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CompletedNCT05822687Updated Sep 30, 2026Results posted

Factorial Optimization Trial to Test Effects of Coping Intervention Components

An interventional study of Education and Reappraisal Coping in Anxiety, Depression and Coping Skills, sponsored by Arizona State University. Completed at 1 site in United States. Open to participants aged 9 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Arizona State University · Not applicable, Interventional, and Prevention

Updated Sep 30, 2026Results postedPrimary outcomes revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
9 Years to 12 Years
Sex
All
01

Study summary

This study will identify components for inclusion in a coping intervention package to reduce mental health problems among children exposed to high interparental conflict after parental separation/divorce. Reappraisal, distraction, and relaxation coping strategies are related to fewer mental health problems among children, making intervention components based on these strategies key candidates for inclusion in an optimized coping intervention. The primary aim is to experimentally assess the main and interactive effects of three digital intervention coping components (reappraisal, distraction, relaxation) on children's coping efficacy, emotional security, and internalizing and externalizing problems. Secondary aims are to assess indirect effects of the intervention components on children's coping efficacy, emotional security, and internalizing and externalizing problems through their cognitive, emotional, and behavioral reactions to post-separation/divorce interparental conflict events.

Read the detailed description

A randomized and counterbalanced 2x2x2 factorial trial (N = 144 children, ages 9-12) will be conducted to assess the individual effects of the three digital coping intervention components. The three components to be tested will be: (1) Reappraisal (No vs. Yes), (2) Distraction (No vs. Yes), (3) Relaxation (No vs. Yes). Components that meet a priori thresholds for meaningful change will be combined to form an intervention package that will be evaluated in a subsequent randomized controlled trial.

02

Conditions studied

  • Anxiety
  • Depression
  • Coping Skills
  • Emotional Problem

Keywords

  • optimization
  • parental divorce/separation
  • interparental conflict
  • adaptive coping
  • child mental health
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 148 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Arizona State University is the lead sponsor of 234 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • child between ages 9-12 whose parents are separated or divorced
  • child and one parent are fluent in English
  • a parent with sufficient contact (i.e., at least 4 overnights and/or 12 daytime visits per month) with child who is willing to complete study assessments and has legal right to give permission for the child to participate in research
  • child-report of high exposure to IPC (mean Z score ≥ 40th percentile on the two child report measures of IPC; score standardization based on data from 559 youth whose parents participated in an experimental parenting program)
  • elevated internalizing or externalizing problems (T score in the borderline clinical range according to either child or parent report on the BPM).

Exclusion criteria

Exclusion Criteria:

  • in active therapy
  • score ≥ 99th percentile on either internalizing and externalizing problems subscale
  • endorse suicidality (will be ineligible for the study and referred for treatment)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
148 participants (actual)

Study arms

  • Experimental
    Education

    Participants will complete an educational digital module and no skills-based digital modules.

    Behavioral: Education

  • Experimental
    Education + Reappraisal

    Participants will complete an educational digital module and a skills-based digital module that teaches reappraisal coping.

    Behavioral: Education · Behavioral: Reappraisal Coping

  • Experimental
    Education + Distraction

    Participants will complete an educational digital module and a skills-based digital module that teaches distraction coping.

    Behavioral: Education · Behavioral: Distraction Coping

  • Experimental
    Education + Relaxation

    Participants will complete an educational digital module and a skills-based digital module that teaches relaxation coping.

    Behavioral: Education · Behavioral: Relaxation Coping

  • Experimental
    Education + Reappraisal + Distraction

    Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches distraction coping.

    Behavioral: Education · Behavioral: Reappraisal Coping · Behavioral: Distraction Coping

  • Experimental
    Education + Reappraisal + Relaxation

    Participants will complete an educational digital module and two skills-based digital modules, one that teaches reappraisal coping and one that teaches relaxation coping.

    Behavioral: Education · Behavioral: Reappraisal Coping · Behavioral: Relaxation Coping

  • Experimental
    Education + Distraction + Relaxation

    Participants will complete an educational digital module and two skills-based digital modules, one that teaches distraction coping and one that teaches relaxation coping.

    Behavioral: Education · Behavioral: Distraction Coping · Behavioral: Relaxation Coping

  • Experimental
    Education + Reappraisal + Distraction + Relaxation

    Participants will complete an educational digital module and three skills-based digital modules, one that teaches reappraisal coping, one that teaches distraction coping, and one that teaches relaxation coping.

    Behavioral: Education · Behavioral: Reappraisal Coping · Behavioral: Distraction Coping · Behavioral: Relaxation Coping

Interventions

  • BehavioralEducation

    This is a constant component; all participants will get a psychoeducation digital module.

  • BehavioralReappraisal Coping

    This digital module will teach reappraisal coping skills.

  • BehavioralDistraction Coping

    This digital module will teach distraction coping skills.

  • BehavioralRelaxation Coping

    This digital module will teach relaxation coping skills.

06

What researchers measure

Primary outcomes

  1. Mean Child-Reported Interparental Emotional Security Score on the SIS-SF at 3-Month Follow-Up

    Child-reported Security in the Interparental Subsystem Scale-Short Form (SIS-SF; Holt et al., 2020). The score is the mean of 17 items rated from 0 (not at all true) to 3 (very true for me). Higher scores indicate greater interparental emotional security (better outcome). The outcome table reports observed scores; factorial analyses adjust for baseline SIS-SF and prespecified covariates.

    Time frame: approximately 3 months after posttest

  2. Mean Child-Reported Family Emotional Security Score on the SIFS at 3-Month Follow-Up

    Child-reported Security in the Family System Scale (SIFS; Forman \& Davies, 2005). The score is the mean of 24 items rated from 0 (completely disagree) to 3 (completely agree). Higher scores indicate greater family emotional security (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline SIFS score and prespecified covariates.

    Time frame: approximately 3 months after posttest

  3. Mean Child-Reported Coping Efficacy Score on the CES at 3-Month Follow-Up

    Child-reported Coping Efficacy Scale (CES; Sandler et al., 2000). The score is the mean of 7 items rated from 0 (not at all) to 3 (very). Higher scores indicate greater coping efficacy (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline CES score and prespecified covariates.

    Time frame: approximately 3 months after posttest

  4. Mean Child-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up

    Child-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Internalizing Problems score and prespecified covariates.

    Time frame: approximately 3 months after posttest

  5. Mean Parent-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up

    Parent-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Internalizing Problems score and prespecified covariates.

    Time frame: approximately 3 months after posttest

  6. Mean Child-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up

    Child-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Externalizing Problems score and prespecified covariates.

    Time frame: approximately 3 months after posttest

  7. Mean Parent-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up

    Parent-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Externalizing Problems score and prespecified covariates.

    Time frame: approximately 3 months after posttest

07

Results

Posted Sep 30, 2026

Participant flow

Participants were recruited from February 2023 through July 2025 through Arizona State University in Tempe, Arizona. Recruitment sources included BuildClinical; Facebook, Instagram, LinkedIn, and other online advertisements; ASU email and MyASU outreach; family-court and public court-record outreach; and referrals from relatives, friends, attorneys, parent coordinators, parenting classes, podcasts or influencers, and community events.

Participant flow — Overall Study
MilestoneEducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + Relaxation
Started1818181819182019
Completed1815171418161716
Not completed03141233

Outcome measures

PrimaryMean Child-Reported Interparental Emotional Security Score on the SIS-SF at 3-Month Follow-Up

Child-reported Security in the Interparental Subsystem Scale-Short Form (SIS-SF; Holt et al., 2020). The score is the mean of 17 items rated from 0 (not at all true) to 3 (very true for me). Higher scores indicate greater interparental emotional security (better outcome). The outcome table reports observed scores; factorial analyses adjust for baseline SIS-SF and prespecified covariates.

Time frame:
approximately 3 months after posttest
Reported as:
Mean · Mean scale score
Mean Child-Reported Interparental Emotional Security Score on the SIS-SF at 3-Month Follow-Up
Mean scale scoreEducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + Relaxation
Mean Child-Reported Interparental Emotional Security Score on the SIS-SF at 3-Month Follow-Up1.01 ± 0.560.88 ± 0.501.29 ± 0.690.81 ± 0.801.16 ± 0.671.28 ± 0.421.22 ± 0.531.27 ± 0.52
Statistical analysis
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.21Posterior median d = -0.21; 95% Bayesian CrI \[-0.69, 0.27\]. Positive values indicate greater interparental emotional security. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.34Posterior median d = -0.34; 95% Bayesian CrI \[-0.80, 0.14\]. Positive values indicate greater interparental emotional security. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.10Posterior median d = -0.10; 95% Bayesian CrI \[-0.59, 0.41\]. Positive values indicate greater interparental emotional security. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.16Posterior median d = 0.16; 95% Bayesian CrI \[-0.30, 0.62\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.26Posterior median d = -0.26; 95% Bayesian CrI \[-0.76, 0.23\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.03Effect-coded 2 x 2 x 2 model adjusted for baseline outcome, age, gender, baseline IPC exposure, and baseline primary-control coping.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.25Posterior median d = 0.25; 95% Bayesian CrI \[-0.22, 0.73\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
PrimaryMean Child-Reported Family Emotional Security Score on the SIFS at 3-Month Follow-Up

Child-reported Security in the Family System Scale (SIFS; Forman \& Davies, 2005). The score is the mean of 24 items rated from 0 (completely disagree) to 3 (completely agree). Higher scores indicate greater family emotional security (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline SIFS score and prespecified covariates.

Time frame:
approximately 3 months after posttest
Reported as:
Mean · score on a scale
Mean Child-Reported Family Emotional Security Score on the SIFS at 3-Month Follow-Up
score on a scaleEducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + Relaxation
Mean Child-Reported Family Emotional Security Score on the SIFS at 3-Month Follow-Up1.11 ± 0.620.78 ± .0321.18 ± 0.390.76 ± 0.450.87 ± 0.501.11 ± 0.360.97 ± 0.391.14 ± 0.51
Statistical analysis
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.05Posterior median d = -0.05; 95% Bayesian CrI \[-0.50, 0.40\]. Positive values indicate greater family emotional security. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.19Posterior median d = -0.19; 95% Bayesian CrI \[-0.62, 0.26\]. Positive values indicate greater family emotional security. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.05Posterior median d = -0.05; 95% Bayesian CrI \[-0.50, 0.40\]. Positive values indicate greater family emotional security. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.08Posterior median d = 0.08; 95% Bayesian CrI \[-0.37, 0.51\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.46Posterior median d = -0.46; 95% Bayesian CrI \[-0.92, -0.00\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.09Posterior median d = -0.09; 95% Bayesian CrI \[-0.53, 0.35\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.15Posterior median d = 0.15; 95% Bayesian CrI \[-0.29, 0.60\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
PrimaryMean Child-Reported Coping Efficacy Score on the CES at 3-Month Follow-Up

Child-reported Coping Efficacy Scale (CES; Sandler et al., 2000). The score is the mean of 7 items rated from 0 (not at all) to 3 (very). Higher scores indicate greater coping efficacy (better outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline CES score and prespecified covariates.

Time frame:
approximately 3 months after posttest
Reported as:
Mean · score on a scale
Mean Child-Reported Coping Efficacy Score on the CES at 3-Month Follow-Up
score on a scaleEducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + Relaxation
Mean Child-Reported Coping Efficacy Score on the CES at 3-Month Follow-Up1.65 ± 0.971.92 ± 0.541.53 ± 0.812.47 ± 0.582.13 ± 0.611.91 ± 0.55-1.93 ± 0.511.84 ± 0.64
Statistical analysis
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): .09Posterior median d = 0.09; 95% Bayesian CrI \[-0.32, 0.50\]. Positive values indicate greater coping efficacy. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.38Posterior median d = -0.38; 95% Bayesian CrI \[-0.79, 0.03\]. Positive values indicate greater coping efficacy. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.66Posterior median d = 0.66; 95% Bayesian CrI \[0.23, 1.09\]. Positive values indicate greater coping efficacy. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.36Posterior median d = 0.36; 95% Bayesian CrI \[-0.05, 0.77\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.52Posterior median d = -0.52; 95% Bayesian CrI \[-0.94, -0.09\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.23Posterior median d = -0.23; 95% Bayesian CrI \[-0.64, 0.18\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.09Posterior median d = -0.09; 95% Bayesian CrI \[-0.50, 0.32\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
PrimaryMean Child-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up

Child-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Internalizing Problems score and prespecified covariates.

Time frame:
approximately 3 months after posttest
Reported as:
Mean · score on a scale
Mean Child-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up
score on a scaleEducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + Relaxation
Mean Child-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up0.59 ± 0.700.39 ± 0.510.81 ± 0.630.30 ± 0.360.57 ± 0.670.48 ± 0.530.68 ± 0.700.52 ± 0.40
Statistical analysis
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.12Posterior median d = 0.12; 95% Bayesian CrI \[-0.36, 0.60\]. Positive values indicate fewer child-reported internalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.30Posterior median d = -0.30; 95% Bayesian CrI \[-0.78, 0.18\]. Positive values indicate fewer child-reported internalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.08Posterior median d = 0.08; 95% Bayesian CrI \[-0.41, 0.58\]. Positive values indicate fewer child-reported internalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.10Posterior median d = 0.10; 95% Bayesian CrI \[-0.37, 0.59\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.05Posterior median d = -0.05; 95% Bayesian CrI \[-0.56, 0.46\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.10Posterior median d = -0.10; 95% Bayesian CrI \[-0.57, 0.38\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.16Posterior median d = 0.16; 95% Bayesian CrI \[-0.32, 0.65\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
PrimaryMean Parent-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up

Parent-reported Brief Problem Monitor (BPM) Internalizing Problems scale. The score is the mean of 6 items rated from 0 (not true) to 2 (very true). Higher scores indicate more internalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Internalizing Problems score and prespecified covariates.

Time frame:
approximately 3 months after posttest
Reported as:
Mean · score on a scale
Mean Parent-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up
score on a scaleEducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + Relaxation
Mean Parent-Reported Internalizing Problems Score on the BPM at 3-Month Follow-Up0.61 ± 0.560.34 ± 0.440.61 ± 0.470.33 ± 0.360.73 ± 0.630.47 ± 0.420.42 ± 0.25056 ± 0.49
Statistical analysis
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.12Posterior median d = 0.12; 95% Bayesian CrI \[-0.36, 0.60\]. Positive values indicate fewer child-reported internalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.30Posterior median d = -0.30; 95% Bayesian CrI \[-0.78, 0.18\]. Positive values indicate fewer child-reported internalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.08Posterior median d = 0.08; 95% Bayesian CrI \[-0.41, 0.58\]. Positive values indicate fewer child-reported internalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.10Posterior median d = 0.10; 95% Bayesian CrI \[-0.37, 0.59\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.05Posterior median d = -0.05; 95% Bayesian CrI \[-0.56, 0.46\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.10Posterior median d = -0.10; 95% Bayesian CrI \[-0.57, 0.38\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.16Posterior median d = 0.16; 95% Bayesian CrI \[-0.32, 0.65\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
PrimaryMean Child-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up

Child-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline child-reported BPM Externalizing Problems score and prespecified covariates.

Time frame:
approximately 3 months after posttest
Reported as:
Mean · score on a scale
Mean Child-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up
score on a scaleEducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + Relaxation
Mean Child-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up0.35 ± 0.320.65 ± 0.440.43 ± 0.460.29 ± 0.360.26 ± 0.270.60 ± 0.420.54 ± 0.580.48 ± 0.43
Statistical analysis
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.13Posterior median d = -0.13; 95% Bayesian CrI \[-0.58, 0.32\]. Positive values indicate fewer child-reported externalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.03Posterior median d = 0.03; 95% Bayesian CrI \[-0.41, 0.48\]. Positive values indicate fewer child-reported externalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.01Posterior median d = -0.01; 95% Bayesian CrI \[-0.47, 0.45\]. Positive values indicate fewer child-reported externalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.52Posterior median d = 0.52; 95% Bayesian CrI \[0.07, 0.96\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.05Posterior median d = -0.05; 95% Bayesian CrI \[-0.52, 0.40\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.14Posterior median d = -0.14; 95% Bayesian CrI \[-0.60, 0.31\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.13Posterior median d = -0.13; 95% Bayesian CrI \[-0.58, 0.32\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
PrimaryMean Parent-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up

Parent-reported Brief Problem Monitor (BPM) Externalizing Problems scale. The score is the mean of 7 items rated from 0 (not true) to 2 (very true). Higher scores indicate more externalizing problems (worse outcome). The outcome table reports observed scores; the attached factorial analyses adjust for the baseline parent-reported BPM Externalizing Problems score and prespecified covariates.

Time frame:
approximately 3 months after posttest
Reported as:
Mean · score on a scale
Mean Parent-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up
score on a scaleEducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + Relaxation
Mean Parent-Reported Externalizing Problems Score on the BPM at 3-Month Follow-Up0.48 ± 0.490.35 ± 0.250.61 ± .0460.23 ± 0.260.38 ± 0.330.64 ± 0.450.43 ± 0.360.30 ± 0.42
Statistical analysis
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.02Posterior median d = -0.02; 95% Bayesian CrI \[-0.34, 0.31\]. Positive values indicate fewer parent-reported externalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.14Posterior median d = -0.14; 95% Bayesian CrI \[-0.46, 0.18\]. Positive values indicate fewer parent-reported externalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.09Posterior median d = 0.09; 95% Bayesian CrI \[-0.24, 0.41\]. Positive values indicate fewer parent-reported externalizing problems. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.23Posterior median d = 0.23; 95% Bayesian CrI \[-0.09, 0.55\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): -0.29Posterior median d = -0.29; 95% Bayesian CrI \[-0.62, 0.03\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.12Posterior median d = 0.12; 95% Bayesian CrI \[-0.20, 0.44\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.
  • Education vs Education + Reappraisal vs Education + Distraction vs Education + Relaxation vs Education + Reappraisal + Distraction vs Education + Reappraisal + Relaxation vs Education + Distraction + Relaxation vs Education + Reappraisal + Distraction + Relaxation · Bayesian factorial regression · Standardized contrast (cohen's d): 0.21Posterior median d = 0.21; 95% Bayesian CrI \[-0.11, 0.53\]. Positive values indicate a positive interaction contrast under the specified effect coding. Adjusted ITT N = 147; missing outcome and baseline-outcome data were jointly modeled.

Adverse events

Collected over enrollment until end of follow-up, up to 22 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Education0/18 (0%)0/18 (0%)0/18 (0%)
Education + Reappraisal0/18 (0%)0/18 (0%)0/18 (0%)
Education + Distraction0/18 (0%)0/18 (0%)0/18 (0%)
Education + Relaxation0/18 (0%)0/18 (0%)0/18 (0%)
Education + Reappraisal + Distraction0/19 (0%)0/19 (0%)0/19 (0%)
Education + Reappraisal + Relaxation0/18 (0%)0/18 (0%)0/18 (0%)
Education + Distraction + Relaxation0/20 (0%)0/20 (0%)0/20 (0%)
Education + Reappraisal + Distraction + Relaxation0/19 (0%)0/19 (0%)0/19 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)EducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + RelaxationTotal
<=18 years1818181819182019148
Between 18 and 65 years000000000
>=65 years000000000
Sex: Female, Male
Sex: Female, Male(Participants)EducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + RelaxationTotal
Female868689111167
Male101210121199881
Race (NIH/OMB)
Race (NIH/OMB)(Participants)EducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + RelaxationTotal
American Indian or Alaska Native000000000
Asian001001002
Native Hawaiian or Other Pacific Islander000000000
Black or African American3324413323
White1415141413131512110
More than one race1010231412
Unknown or Not Reported000000101
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)EducationEducation + ReappraisalEducation + DistractionEducation + RelaxationEducation + Reappraisal + DistractionEducation + Reappraisal + RelaxationEducation + Distraction + RelaxationEducation + Reappraisal + Distraction + RelaxationTotal
Hispanic or Latino3312544022
Not Hispanic or Latino1415171512131519120
Unknown or Not Reported100121106
08

Study locations

1 site
  • Arizona State University
    Tempe, Arizona 85087, United States
09

References and documents

Publications

  • O'Hara KL, Wolchik SA, Sandler IN, West SG, Reis HT, Collins LM, Lyon AR, Cummings EM. Preventing Mental Health Problems in Children After High Conflict Parental Separation/Divorce Study: An Optimization Randomized Controlled Trial Protocol. Ment Health Prev. 2023 Dec;32:200301. doi: 10.1016/j.mhp.2023.200301. Epub 2023 Sep 16. PubMed 38496232 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 8, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Study results will be shared through presentations at conferences and submissions in peer-reviewed journals. In addition, after taking all steps necessary to minimize possible re-identification of confidential data, I will make data, codebooks, and analysis scripts available to appropriate parties to verify findings and conclusions.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

10

Updates

1 registry update since Sep 25, 2026
Results
Results posted
posted Sep 30, 2026
Also revised
primary outcomes
Show all 1 update
  1. Sep 30, 2026
    Results posted
    Primary outcomes Revised (22 changes)
    + 4 other changes: verification date, secondary outcomes, references and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05822687
Lead sponsor
Arizona State University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Karey O'Hara (Assistant Professor, Arizona State University) — Principal investigator
First posted
Apr 21, 2023
Start date
Feb 18, 2023
Primary completion
Mar 30, 2026
Completion
Mar 30, 2026
Results posted
Sep 30, 2026
Last update
Sep 30, 2026

Study contacts

Karey L O'Hara, PhD
principal investigator · Arizona State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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