An interventional study of Treatment as usual (TAU) and Preadolescent SITB Intervention in Self-injury, Suicidal Ideation and Behavior and Executive Functioning, sponsored by University of Colorado, Denver. Not yet recruiting at 1 site in United States. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
The goal of this study is to develop and test an outpatient intervention for preadolescents (ages 7-12) with self-injurious thoughts and behaviors (SITBs).
The main questions it aims to answer are:
In Phase 1 (pre-implementation, months 1-6), enrolled preadolescent and caregiver dyads will receive TAU. In Phase 2 (post-implementation, months 7-13), enrolled dyads will receive the newly-developed SITB intervention. Participants will be recruited through referrals from the psychiatric emergency department at Children's Hospital Colorado. Participants will:
In Stage 1 of the study (Aim 1), the investigators will iteratively design an intervention for preadolescent SITBs through a step-by-step process using frameworks for systematically developing and adapting interventions (Wingood et al., 2008; Bartholomew et al., 1998). The design process will incorporate user-centered design methods, whereby multisectoral experts and end-users (i.e., therapists and families) will participate in the design process to maximize the intervention's dissemination and implementation potential. In Stage 2 of the study (Aims 2 and 3), the new intervention will be evaluated using a quasi-experimental, pre-post implementation design including 52 preadolescents and caregiver(s), recruited through the CHCO emergency department (ED) at the Anschutz Campus.
In Stage 1, the investigators will use mixed methods approaches and user-centered design principles to iteratively develop the preadolescent SITB intervention. Through a needs assessment, the investigators will use an exploratory sequential qualitative--> quantitative mixed methods design, whereby qualitative interviews with therapists will inform the development of a quantitative survey assessing needs and experiences of therapists treating preadolescents with SITBs. Results from the therapist assessment will be integrated with findings from qualitative interviews with preadolescents and caregiversto further inform initial decisions about core functions and specific components of the intervention. During a pre-testing phase utilizing a concurrent mixed methods approach, therapists and preadolescents/families will participate in think-aloud design sessions to provide quantitative and qualitative feedback about rough intervention prototypes. An initial draft of the intervention will then be produced and reviewed by a group of experts, resulting in a second draft of the intervention and therapist training and consultation procedures. A single-arm, intervention development trial with 6 preadolescents will inform adaptations to the intervention, therapist training, and trial procedures.
In Stage 2, the investigators will evaluate the feasibility and acceptability of the study methods and intervention, implementation, and changes in SITB and mental health outcomes using a quasi-experimental, pre-post implementation design (ADAPT-ITT Step 8, Part 2). The trial will have two phases. In Phase 1 of the trial (pre-implementation, months 1-6), enrolled participants will receive treatment as usual (TAU); in Phase 2 of the trial (post-implementation, months 7-13), enrolled participants will receive the new intervention. All treatment will be delivered at the Crisis Clinic at Children's Hospital Colorado, which provides short-term (i.e., 6-12 session) outpatient crisis intervention to youth referred from the ED. Clinicians (up to N = 16) will be recruited from the Crisis Clinic to participate. During Phase 1, clinicians will provide treatment using their typical clinical practice. Prior to Phase 2, clinicians will receive training in the new intervention and will receive monthly consultation support from the developers throughout the implementation phase. Aim 2 will evaluate feasibility, acceptability, and implementation outcomes for the intervention and study procedures. Aim 3 will be to collect preliminary evidence to explore changes in SITBs, hypothesized target mechanisms of EF and emotion regulation, and mental health symptoms relative to TAU.
569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.
This study's planned enrollment of 52 is below the median of 80 across 469 interventional studies indexed under Suicidal Ideation.
Browse Suicidal Ideation studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Compared within Suicidal Ideation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Self-Injurious Behavior. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Experimental intervention for preadolescent SITBs targeting executive functioning, emotion regulation, and other SITB risk factors
Behavioral: Preadolescent SITB Intervention
Treatment as Usual provided by outpatient mental health therapist
Behavioral: Treatment as usual (TAU)
Typical interventions Outpatient therapist would provide to a preadolescent with SITBs, based on their clinical judgement
Experimental intervention developed with end-users and experts to target emotion regulation, executive functioning, and other risk factors for SITBs in preadolescents
Feasibility of recruitment
% recruitment targets met (benchmark = 52 preadolescents enrolled within 13 months)
Time frame: Calculated at enrollment
Suicidal Ideation Intensity
Measured using the Columbia Suicide and Self Injury Severity Rating Scale (C-SSRS; Posner et al., 2011), a brief interview that consists of sections that assess: suicidal ideation, ideation intensity, and suicidal behavior. The C-SSRS has strong convergent validity, sensitivity to change, predictive and incremental validity, and good internal consistency.
Time frame: From enrollment to 3-month follow-up at 20 weeks
Feasibility of Retention
% participants completing treatment (benchmark =≥ 80% participants considered treatment completers)
Time frame: From enrollment to the end of treatment at 8 weeks
Perceived Appropriateness of Intervention
The Intervention Appropriateness Measure (IAM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists. The IAM is a 4-item measure assessing the extent to which stakeholders believe an intervention or to be appropriate. Items are rated from 1 ("completely disagree") to 5 ("completely agree"), with higher scores indicating greater appropriateness. The appropriateness benchmark for all reporters is set at a mean score of 4 or greater.
Time frame: From enrollment to the end of treatment at 8 weeks
Perceived Feasibility of Intervention
The Feasibility of Intervention Measure (FIM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists. The FIM is a 4-item measures assessing the extent to which stakeholders believe an intervention to be feasible. Items are rated from 1 ("completely disagree") to 5 ("completely agree"), with higher scores indicating greater feasibility. The feasibility benchmark for all reporters is set at a mean score of 4 or greater.
Time frame: From enrollment to the end of treatment at 8 weeks
Perceived acceptability of intervention
The Acceptability of Intervention Measure (AIM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists. The AIM is a 4-item measure assessing the extent to which stakeholders believe an intervention to be acceptable. Items are rated from 1 ("completely disagree") to 5 ("completely agree"), with higher scores indicating greater acceptability. The acceptability benchmark for all reporters is set at a mean score of 4 or greater.
Time frame: From enrollment to the end of treatment at 8 weeks
Treatment Engagement
Number of treatment sessions completed at post-treatment, compared to prescribed or recommended number of sessions
Time frame: From enrollment to post-treatment at 8 weeks
Readmission/Admission Rates
Readmission/admission rates to the psychiatric ED or inpatient psychiatric hospitalization will be evaluated via caregiver report on the Brief form of the Services Assessment for Children and Adolescents (SACA; Horwitz et al., 2001), which will be supplemented with chart review.
Time frame: From enrollment to 3-month follow-up at 8 weeks
Feasibility of Measurement
% participants at each timepoint completing measures (target = ≥ 80% at each timepoint).
Time frame: From enrollment to follow-up at 20 weeks
Non-Suicidal Self-Injury
Measured using an adapted version of the Self-Injurious Thoughts and Behaviors Interview (SITBI)-Short Form, Thoughts of NSSI and NSSI subscales (Nock et al., 2007), which assesses history and characteristics of NSSI thoughts and behaviors. First instance of engagement in NSSI after beginning treatment will be the outcome of most interest, but other outcomes assessed by the interview (e.g., frequency of NSSI thoughts) may be examined as well if rates of NSSI are very low.
Time frame: From enrollment to 3-month follow-up at 20 weeks
Anxiety Symptoms
We will measure anxiety using the Revised Child Anxiety and Depression Scale (RCADS)-Short Version (Ebesutani et al., 2012; 2017), which is a 25-item measure of depression and anxiety symptoms that includes both parent-and self-report measures. Both versions are rated on a 5-point Likert scale, with higher scores indicating greater frequency of anxiety symptoms. Anxiety items are summed to yield a raw score, which is then converted to a t-score. The measure has good psychometric properties and treatment sensitivity (Ebesutani et al., 2012; 2017).
Time frame: From enrollment to 3-month follow-up at 20 weeks
Depression Symptoms
We will measure depression using the Revised Child Anxiety and Depression Scale (RCADS)-Short Version (Ebesutani et al., 2012; 2017), which is a 25-item measure of depression and anxiety symptoms that includes both parent-and self-report measures. Both versions are rated on a 5-point Likert scale, with higher scores indicating greater frequency of depression symptoms. Depression items are summed to yield a total raw score, which is then converted to a t-score. The measure has good psychometric properties and treatment sensitivity (Ebesutani et al., 2012; 2017).
Time frame: From enrollment to 3-month follow-up at 20 weeks
Disruptive Behavior Symptoms
We will measure disruptive behaviors using the Disruptive Behavior Disorders Scale (DBRS)-Parent Version (Fosco et al., 2023), a 45-item rating scale used to assess symptoms of inattention, hyperactivity-impulsivity, and oppositional defiant behavior among school-aged children. Items are rated on a 4-point scale, with higher scores indicating greater severity of symptoms.
Time frame: From enrollment to 3-month follow-up at 20 weeks
Emotion Dysregulation--Reactivity
Measured using the Emotion Dysregulation Inventory-Reactivity Short Form (EDI-R; Mazefsky et al., 2018; 2021), which includes a 7-item, caregiver report measure of emotional reactivity. Items are rated on a 5-point Likert scale, with higher scores indicating greater emotional reactivity.
Time frame: From enrollment to 3-month follow-up at 20 weeks
Emotion Dysregulation--Dysphoria
Measured using the Emotion Dysregulation Inventory-Dysphoria Short Form (EDI-D; Mazefsky et al., 2018; 2021), which is a 6-item, caregiver report measure of dysphoria in youth. Items are rated on a 5-point Likert scale, with higher scores indicating greater dysphoria.
Time frame: From enrollment to 3-month follow-up at 20 weeks
Caregiver Report of Preadolescent Executive Functioning
The Brief Rating Inventory of Executive Function 2nd Edition (BRIEF 2) --Parent Form (Gioia et al., 2015) is 63-item questionnaire with eight clinical scales designed to assess everyday behaviors associated with seven domains of EF. These scales are combined to form two broader indices (Behavioral Regulation and Metacognition) and a Global Executive Composite score. Items are rated on a 4-point scale, and sum scores for each scale and index are converted to t-scores, with higher t-scores indicating greater difficulties with executive functioning. The measure has strong psychometric properties, discriminates between typically developing and clinical populations, and is sensitive to change.
Time frame: From enrollment to 3-month follow-up at 20 weeks
Behavioral Assessment of Executive Functioning and Distress Tolerance
Executive Function Challenge Task (EFCT; Kenworthy et al., 2014, 2020) is a "hot" measure of EF that uses a standardized protocol to assess flexibility and planning during several activities with an examiner that change rules or modalities. The EFCT has precise behavioral markers to guide scoring on a three-point scale and yields flexibility and planning raw scores that range from 0 to 8. The EFCT has good psychometric properties and demonstrated moderate associations with parent-reported EF and treatment-specific sensitivity to change (Kenworth et al., 2014; 2020).
Time frame: From enrollment through post-treatment at 8 weeks
Task-Based Assessment of Executive Functioning
NIH toolbox Dimensional Change Card Sort test (DCCS; Kavanaugh et al., 2020; Zelazo et al., 2013). is a standard, lab-based, computerized task for assessing cognitive flexibility, will be administered as a computerized measure of EF. The DCCS has been validated in youth, does not demonstrate practice effects, and has excellent convergent validity.
Time frame: From enrollment to the end of treatment at 8 weeks
Plan to share: Yes — IPD from the randomized controlled trial will be shared with the NIMH National Data Archive.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for May 2028, 17 months later.
Of 281 non-industry interventional studies with no phase under Suicidal Ideation, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 17 months is below that.
Counting every sponsor, half of 290 studies reached it within 29 months; a quarter within 13 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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