An interventional study of SAHP in Parenting Behaviors and PTSD Symptoms, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
Among 64 studies in Stress Disorders, Traumatic with a site in United States — 11 open to participants now, 11 under way, none of them phase 3. Stress Disorders, Traumatic · United States.
Among the 64 studies in Stress Disorders, Traumatic with a site in United States, this one is the 20th largest by enrollment of the 58 interventional ones that give a count, is one of 6 that started in 2019, is one of 44 with no phase, and was the 37th registered.
120 studies on the registry are indexed under Stress Disorders, Traumatic; 23 are open to participants now.
Browse Stress Disorders, Traumatic studies →11 of the 64 studies in Stress Disorders, Traumatic with a site in United States are open now. Recruiting first, the newest first:
University of North Carolina, Chapel Hill · Sites in United States
SoundHeal · Sites in United States
University of Arkansas · Sites in United States
Foundation for Atlanta Veterans Education and Research, Inc. · Sites in United States
The University of Texas at Dallas · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 15 Stress Disorders, Traumatic studies recruiting now, 5 (33%) set no upper age limit and 9 (60%) stop at 75 or younger; 2 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
64 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 6 started in 2019.
This study's enrollment of 91 is above the median of 67 across 97 interventional studies indexed under Stress Disorders, Traumatic.
Median enrollment 46 across the 58 interventional studies, 69 across the 5 observational. Of the 46 that completed or were terminated, 16 (35%) have results posted.
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4 of 64 have an industry lead sponsor. The 10 most frequent:
VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
VA Office of Research and Development has 7 studies filed under Stress Disorders, Traumatic — fewer than ten, so there is no comparison to draw.
7 of the studies in Stress Disorders, Traumatic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06234371Christopher CroninFinancial Incentives for Veteran Therapy Completion | 2027-01-02 |
| NCT05674617VA Office of Research and DevelopmentPTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes | 2027-03-31 |
| NCT06770998Foundation for Atlanta Veterans Education and Research, Inc.A Study of a Novel EEG Neurofeedback System for PTSD Treatment | 2027-06 |
| NCT07002554Medical University of South CarolinaBright Light Therapy for Depressed Geriatric Inpatients | 2027-06-30 |
| NCT07196332University of North Carolina, Chapel HillRecovering Sleep After Trauma | 2027-09 |
Among the 64 studies in Stress Disorders, Traumatic with a site in United States, from their registry updates:
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The overall goal of this work is to adapt, refine, and conduct an open trial of a parent-training intervention for Veterans with posttraumatic stress disorder (PTSD) symptoms using feedback from Veterans, VA clinicians, and expert consultants as key stakeholders. PTSD symptoms are associated with parent-child functioning difficulties, which are also an important determinant of quality of life and functional recovery. This project will examine the feasibility and acceptability of an evidence-based group intervention to improve parenting behaviors, parenting satisfaction, and family functioning in Veteran parents with PTSD symptoms and who have children between the ages of 3 and 12.
This intervention is derived from an existing evidence-based intervention to improve Veteran relationship functioning (Strength at Home; SAH), and it is informed by the Cognitive Behavioral Theory of Interpersonal Functioning and the Military Family Attachment frameworks for the association between PTSD and family functioning problems. The intervention also includes a pre-treatment Motivational Interviewing Assessment (MIA) to assist Veterans in strengthening and building motivation to change their parenting behaviors. The goals and change talk identified in the pre-treatment MIA are then referred to throughout the treatment. Groups are gender-specific, meaning that the investigators will pilot the treatment in separate groups of women and men Veterans.
Symptoms of posttraumatic stress disorder (PTSD) after deployment have been shown to adversely impact family and close relationship functioning, including parent-child relationships. About 31% of U.S. Veterans are parents to children under the age of 18. In addition, a study of over 100,000 records of Iraq and Afghanistan Veterans indicated those with dependent children were 40% more likely to carry a diagnosis of PTSD compared to those without children. Despite these large numbers and the known association between PTSD and parenting problems, there are no empirically validated parenting interventions within the VHA that address the unique needs of Veteran parents with PTSD, nor is there evidence that existing treatments for PTSD improve family functioning. This gap in both research and practice is significant given that parent-child functioning is a large component of recovery and reintegration into the community. Difficulties with parenting and the parent-child relationship are a vital influence on overall family functioning and quality of life. It follows logically that an intervention that improves parenting will have a significant downstream impact on overall family and close relationship functioning and the Veteran's quality of life.
This proposal will conduct the research necessary to adapt, refine, and conduct an open trial of Strength at Home - Parents (SAHP) - the new intervention incorporates the core clinical components of the empirically validated Strength at Home (SAH) interventions for improved family functioning among Veterans and targets key parenting behaviors and interpersonal relationship skills that can be impaired when a parent suffers from PTSD.
Given that parenting challenges are not typically addressed within VHA, one reason prior national pilot efforts may have had trouble with enrollment and retention is a failure to address motivation and goal setting at the outset. It can be difficult for clients to be ready to change a problem when few resources have historically been available to address it. Therefore this proposal will pilot the feasibility of including a pre-treatment Motivational Interviewing Assessment (MIA15) to assist Veterans with PTSD in strengthening and building motivation to change their parenting behaviors. The MIA can result in higher rates of treatment retention during the first 4 weeks of treatment compared to treatment as usual. Assessment approaches such as MIA that are personalized and collaborative have been shown to have a positive and clinically meaningful impact on treatment.
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.
Current parent to a child between the ages of 3 and 12.
Screen positive for elevated PTSD symptoms on the PTSD checklist for DSM 5 (PCL-5)
Screen positive (above the 85th percentile) for parent-child functioning problems based on Parenting Stress Index- Short Form; PSI-SF
Exclusion Criteria:
Major neurocognitive disorder, including due to TBI
Untreated/poorly managed psychosis or substance dependence
Current suicide risk
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All Participants will complete the 8-week parenting support intervention and will provide satisfaction and acceptability ratings of the intervention. In the pilot trial, participants will make these ratings after each session, in the open trial the ratings will be made pre and post intervention.
Behavioral: SAHP
Aim 1: To obtain and incorporate expert clinician and Veteran feedback on credibility, acceptability, and satisfaction with the intervention to ensure Veteran-friendly intervention manual, materials, and processes. Aim 1 will be accomplished through two rounds of expert panel review of treatment/MIA manual and two rounds of pilot testing of the treatment for Veteran Feedback in 16 female and 16 male Veterans. Aim 2: To evaluate feasibility of study recruitment, retention, assessment procedures and proposed methods of the intervention. Preliminary examination of whether the intervention results in improvements to parenting behaviors, parenting satisfaction and overall family functioning.
Client Satisfaction Questionnaire-8 (CSQ; Attkisson & Greenfield, 2004)
The Client Satisfaction Questionnaire-8 (CSQ) assesses acceptability post-treatment. Eight items are scored on a 4-point scale inquiring about quality of services, treatment satisfaction, and willingness to recommend the treatment to others. Ratings are summed, with higher scores representing greater acceptability ratings (possible range 4-32). This measure is commonly used in both clinical trials and program evaluation, and has been shown to correlate with treatment attendance and outcomes. It takes approximately three minutes to complete. Evaluations of the measure found it to be reliable, with high coefficient alphas (.83-.93) to support internal consistency, and that it evidences positive construct validity with other measures of satisfaction. Where available, mean CSQ ratings can also be compared against norms from other studies in similar populations.
Time frame: 8 weeks
Strength at Home Parents Specific Satisfaction Questionnaire
Measure was designed for this study and administered after each session to assess satisfaction with session components, overall session content, and homework. Sample questions include "The group exercise on child attachment was useful in understanding my child's behavior" and "The number of take home practice assignments is reasonable". Items are scored on a 9-point scale and averaged (range 0 - 8) with higher scores representing greater treatment satisfaction. Additional qualitative feedback was obtained using open-ended questions.
Time frame: 8 weeks
The Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
Measure was administered after first and last session to assess participants perspectives on whether the intervention was logical and their expectations for the success of the intervention. There are 4 items scored on an 8-point scale (range 0-32), with higher scores representing greater credibility, and a reported mean score of 24.96 in standardization samples. Although CEQ session ratings were used to guide manual revisions, only CEQ scores at pre and post-treatment were evaluated for this report. The CEQ has high internal consistency and test-re-test reliability (Devilly \& Borkovec, 2000).
Time frame: 8 weeks
The Parenting Stress Index, 4th Edition (PSI; Abidin, 2012)
Measure has 120 items scored on a 5-point scale, yielding a parent domain score, a child domain scale measuring stress related to parent and child characteristics respectively. These scale scores are combined (Summed) to yield a parenting stress index total score with higher scores reflecting greater stress. The PSI has high reliability coefficients, internal consistency, and test-retest reliability. The measure has been validated for use in various populations (Abidin, 2012). The range for the total score is 20-100.
Time frame: 8 weeks
The Family Assessment Device General Family Functioning Scale (FAD; Epstein, Baldwin, & Bishop, 1983)
Measure is a 12-item measure on a 4 - point scale measuring general family functioning. Items are averaged (range 1 to 4), with higher scores reflecting impaired family functioning. The FAD has high Cronbach's alpha (.86), and split-half reliability (.83) (Byles, et al., 1988). Consistency between responses to the 12-item FAD, and related family variables provides validity evidence.
Time frame: 8 weeks
The Pediatric Symptom Checklist (PSC; Jellinek, et al., 1986)
Measure is a 35-item measure on a 3-point scale assessing parents' impressions of their child's psychosocial functioning. Scores range from 0 to 70, with higher scores reflecting greater psychosocial problems and impairment. The PSC converges with the Child Behavior Checklist, an established self-report measures of child psychosocial difficulties (Jellinek et al., 1986).
Time frame: 8 weeks
The Parenting Scale Laxness Subscale
Parental discipline practices were measured with the laxness and hostility subscales of the Parenting Scale (PS; Arnold et al., 1993). Scores are averaged with higher scores reflecting more dysfunctional parenting practices. Items are anchored by one effective and one ineffective discipline strategy rated on a 1 to 7 scale. The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline e.g. "If my child gets upset when I say 'no': I back down and give in to my child (1)... I stick to what I said (7)." The overreactivity scale measures use of emotional, harsh discipline such as "When my child misbehaves I spank, slap, grab, or hit my child... never or rarely (1) .... most of the time (7)." Adequate internal consistency and reliability have been demonstrated, and the scale correlates well with observational measures of dysfunctional discipline and child misbehavior (Arnold et al. 1993).
Time frame: 8 weeks
Beck Depression Inventory-II (BDI-II; Beck et al. 1996)
Measure is a 21-item measure on a 4-point scale assessing depression symptom severity. Scores range from 0 to 63 with higher scores reflecting increased endorsement of depressive symptoms. The BDI-II has high internal consistency, good test-retest reliability (.94), and correlates highly with other interview-based measures of depression (Sprinkle et al., 2002).
Time frame: 8 weeks
PTSD Checklist for DSM-5 (PCL-5; Weathers et al. 2013)
Measure is a 20-item measure on a 5-point scale assessing PTSD symptom severity. Scores range from 0 to 80 with higher scores reflecting increased endorsement of PTSD symptoms. The measure has good internal consistency, test-retest reliability and convergent and discriminant validity (Blevins, et al., 2015). The PCL-5 is as sensitive to clinical change that occurs between pre-and post- treatment as golden standard interview-based measures of PTSD symptoms (Worthmann et al., 2016).
Time frame: 8 weeks
Parenting Stress Index Hostility Subscale
Parental discipline practices were measured with the laxness and hostility subscales of the Parenting Scale (PS; Arnold et al., 1993). Scores are averaged with higher scores reflecting more dysfunctional parenting practices. Items are anchored by one effective and one ineffective discipline strategy rated on a 1 to 7 scale. The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline e.g. "If my child gets upset when I say 'no': I back down and give in to my child (1)... I stick to what I said (7)." The overreactivity scale measures use of emotional, harsh discipline such as "When my child misbehaves I spank, slap, grab, or hit my child... never or rarely (1) .... most of the time (7)." Adequate internal consistency and reliability have been demonstrated, and the scale correlates well with observational measures of dysfunctional discipline and child misbehavior (Arnold et al. 1993).
Time frame: 8 weeks
Recruitment was conducted between 3/01/2019 and 11/8/2019. Participants self-referred through study flyers or were recruited through letters sent to those veterans who met initial study eligibility based on medical record data.
| Milestone | SAHP Pilot | SAHP Open Trial |
|---|---|---|
| Started | 21 | 53 |
| Completed | 20 | 47 |
| Not completed | 1 | 6 |
The Client Satisfaction Questionnaire-8 (CSQ) assesses acceptability post-treatment. Eight items are scored on a 4-point scale inquiring about quality of services, treatment satisfaction, and willingness to recommend the treatment to others. Ratings are summed, with higher scores representing greater acceptability ratings (possible range 4-32). This measure is commonly used in both clinical trials and program evaluation, and has been shown to correlate with treatment attendance and outcomes. It takes approximately three minutes to complete. Evaluations of the measure found it to be reliable, with high coefficient alphas (.83-.93) to support internal consistency, and that it evidences positive construct validity with other measures of satisfaction. Where available, mean CSQ ratings can also be compared against norms from other studies in similar populations.
| score on a scale | SAHP Pilot |
|---|---|
| Client Satisfaction Questionnaire-8 (CSQ; Attkisson & Greenfield, 2004) | 29.9 (4 to 32) |
Measure was designed for this study and administered after each session to assess satisfaction with session components, overall session content, and homework. Sample questions include "The group exercise on child attachment was useful in understanding my child's behavior" and "The number of take home practice assignments is reasonable". Items are scored on a 9-point scale and averaged (range 0 - 8) with higher scores representing greater treatment satisfaction. Additional qualitative feedback was obtained using open-ended questions.
| score on a scale | SAHP Pilot |
|---|---|
| Strength at Home Parents Specific Satisfaction Questionnaire | 6.65 (0 to 8) |
Measure was administered after first and last session to assess participants perspectives on whether the intervention was logical and their expectations for the success of the intervention. There are 4 items scored on an 8-point scale (range 0-32), with higher scores representing greater credibility, and a reported mean score of 24.96 in standardization samples. Although CEQ session ratings were used to guide manual revisions, only CEQ scores at pre and post-treatment were evaluated for this report. The CEQ has high internal consistency and test-re-test reliability (Devilly \& Borkovec, 2000).
| score on a scale | SAHP Pilot |
|---|---|
| 1st session | 27.7 (0 to 32) |
| last session | 28.9 (0 to 32) |
Measure has 120 items scored on a 5-point scale, yielding a parent domain score, a child domain scale measuring stress related to parent and child characteristics respectively. These scale scores are combined (Summed) to yield a parenting stress index total score with higher scores reflecting greater stress. The PSI has high reliability coefficients, internal consistency, and test-retest reliability. The measure has been validated for use in various populations (Abidin, 2012). The range for the total score is 20-100.
| score on a scale | SAHP Open Trial |
|---|---|
| Pre-treatment | 62 ± 8.95 |
| post-treatment | 55.5 ± 7.95 |
Measure is a 12-item measure on a 4 - point scale measuring general family functioning. Items are averaged (range 1 to 4), with higher scores reflecting impaired family functioning. The FAD has high Cronbach's alpha (.86), and split-half reliability (.83) (Byles, et al., 1988). Consistency between responses to the 12-item FAD, and related family variables provides validity evidence.
| score on a scale | SAHP Open Trial |
|---|---|
| pre-treatment | 2.17 ± .5 |
| post-treatment | 1.86 ± .6 |
Measure is a 35-item measure on a 3-point scale assessing parents' impressions of their child's psychosocial functioning. Scores range from 0 to 70, with higher scores reflecting greater psychosocial problems and impairment. The PSC converges with the Child Behavior Checklist, an established self-report measures of child psychosocial difficulties (Jellinek et al., 1986).
| score on a scale | SAHP Open Trial |
|---|---|
| Pre-treatment | 20.6 ± 8.06 |
| post-treatment | 15.7 ± 8.12 |
Parental discipline practices were measured with the laxness and hostility subscales of the Parenting Scale (PS; Arnold et al., 1993). Scores are averaged with higher scores reflecting more dysfunctional parenting practices. Items are anchored by one effective and one ineffective discipline strategy rated on a 1 to 7 scale. The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline e.g. "If my child gets upset when I say 'no': I back down and give in to my child (1)... I stick to what I said (7)." The overreactivity scale measures use of emotional, harsh discipline such as "When my child misbehaves I spank, slap, grab, or hit my child... never or rarely (1) .... most of the time (7)." Adequate internal consistency and reliability have been demonstrated, and the scale correlates well with observational measures of dysfunctional discipline and child misbehavior (Arnold et al. 1993).
| score on a scale | SAHP Open Trial |
|---|---|
| pre-treatment | 2.68 ± 1.14 |
| post-treatment | 2.38 ± .93 |
Measure is a 21-item measure on a 4-point scale assessing depression symptom severity. Scores range from 0 to 63 with higher scores reflecting increased endorsement of depressive symptoms. The BDI-II has high internal consistency, good test-retest reliability (.94), and correlates highly with other interview-based measures of depression (Sprinkle et al., 2002).
| score on a scale | SAHP Open Trial |
|---|---|
| Pre-treatment | 27.6 ± 13 |
| Post-treatment | 21 ± 11.8 |
Measure is a 20-item measure on a 5-point scale assessing PTSD symptom severity. Scores range from 0 to 80 with higher scores reflecting increased endorsement of PTSD symptoms. The measure has good internal consistency, test-retest reliability and convergent and discriminant validity (Blevins, et al., 2015). The PCL-5 is as sensitive to clinical change that occurs between pre-and post- treatment as golden standard interview-based measures of PTSD symptoms (Worthmann et al., 2016).
| score on a scale | SAHP Open Trial |
|---|---|
| pre-treatment | 44.1 ± 16.1 |
| post-treatment | 35.5 ± 17.8 |
Parental discipline practices were measured with the laxness and hostility subscales of the Parenting Scale (PS; Arnold et al., 1993). Scores are averaged with higher scores reflecting more dysfunctional parenting practices. Items are anchored by one effective and one ineffective discipline strategy rated on a 1 to 7 scale. The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline e.g. "If my child gets upset when I say 'no': I back down and give in to my child (1)... I stick to what I said (7)." The overreactivity scale measures use of emotional, harsh discipline such as "When my child misbehaves I spank, slap, grab, or hit my child... never or rarely (1) .... most of the time (7)." Adequate internal consistency and reliability have been demonstrated, and the scale correlates well with observational measures of dysfunctional discipline and child misbehavior (Arnold et al. 1993).
| units on a scale | SAHP Open Trial |
|---|---|
| pre-treatment | 2.35 ± 1.25 |
| post-treatment | 1.86 ± .94 |
Collected over Two months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pilot Trial | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Open Trial | 1/53 (1.9%) | 1/53 (1.9%) | 0/53 (0%) |
| Event | Pilot Trial | Open Trial |
|---|---|---|
| Serious, anticipated, unrelated adverse eventPsychiatric disorders | 0/21 | 1/53 |
| Age, Categorical(Participants) | SAHP Pilot | SAHP Open Trial | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 53 | 74 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | SAHP Pilot | SAHP Open Trial | Total |
|---|---|---|---|
| Female | 12 | 28 | 40 |
| Male | 9 | 25 | 34 |
| Ethnicity (NIH/OMB)(Participants) | SAHP Pilot | SAHP Open Trial | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 10 | 10 |
| Not Hispanic or Latino | 0 | 43 | 43 |
| Unknown or Not Reported | 21 | 0 | 21 |
| Race (NIH/OMB)(Participants) | SAHP Pilot | SAHP Open Trial | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 15 | 17 |
| White | 12 | 24 | 36 |
| More than one race | 7 | 10 | 17 |
| Unknown or Not Reported | 0 | 4 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Upon written request and IRB approval of sharing, final datasets will be made available in electronic computer readable form. Only de-identified non-PHI raw data will be shared.
Ran from Mar 2019 to primary completion in Mar 2022, 36 months.
Results were first posted in Jul 2024, 2 years 3 months after primary completion.
Of 50 non-industry interventional studies with no phase under Stress Disorders, Traumatic, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's 36 months is close to that.
Counting every sponsor, half of 52 studies reached it within 33 months; a quarter within 14 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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