N/A
N=74
Parenting Strength At Home- Parents Pilot
Parenting Behaviors and PTSD Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT03403153 ↗Enrolled (actual)
74
Serious AEs
1.4%
Results posted
Jul 2024
Primary outcome: Primary: Client Satisfaction Questionnaire-8 (CSQ; Attkisson & Greenfield, 2004) — 29.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SAHP (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Client Satisfaction Questionnaire-8 (CSQ; Attkisson & Greenfield, 2004) |
29.9 | — |
| PRIMARY Strength at Home Parents Specific Satisfaction Questionnaire |
6.65 | — |
| PRIMARY The Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000) |
27.7; 28.9 | — |
| SECONDARY The Parenting Stress Index, 4th Edition (PSI; Abidin, 2012) |
62; 55.5 | <0.01 sig |
| SECONDARY The Family Assessment Device General Family Functioning Scale (FAD; Epstein, Baldwin, & Bishop, 1983) |
2.17; 1.86 | <.01 sig |
| SECONDARY The Pediatric Symptom Checklist (PSC; Jellinek, et al., 1986) |
20.6; 15.7 | <.01 sig |
| SECONDARY The Parenting Scale Laxness Subscale |
2.68; 2.38 | <.01 sig |
| SECONDARY Beck Depression Inventory-II (BDI-II; Beck et al. 1996) |
27.6; 21 | <.01 sig |
| SECONDARY PTSD Checklist for DSM-5 (PCL-5; Weathers et al. 2013) |
44.1; 35.5 | <.01 sig |
| SECONDARY Parenting Stress Index Hostility Subscale |
2.35; 1.86 | <.01 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- English speaking and able to provide written informed consent
- Current parent to a child between the ages of 3 and 12.
- If the parent has more than one child within the target group, they will choose one of their children to be the index child for the purposes of SAHP
- Though we expect skills learned will translate to other children in the family
- The child must reside with the Veteran or spend at least an average of two days per week with the Veteran
- Screen positive for elevated PTSD symptoms on the PTSD checklist for DSM 5 (PCL-5)
- The PCL-5 is a 20 item self-report measure of PTSD symptoms in the past month. Items are rated on a 5 point Likert scale (0 = not at all, 4= extremely) and participants endorse symptoms based on "a very stressful experience."
- Items are summed with higher scores reflecting greater symptomatology. The measure evidences good reliability (Internal consistency = .96; test-retest = .84), discriminant and convergent validity and takes 5-10 min. to complete
- Screen positive (above the 85th percentile) for parent-child functioning problems based on Parenting Stress Index- Short Form; PSI-SF
- All three subscales and the total stress scale on the short-form are highly correlated with those on the long-form (.97-.99), and is expected to take respondents about 10 minutes to complete
- The total stress scale can successfully differentiate between different levels of risk for parent-child functioning problems and has strong convergent validity. High Cronbach's alpha scores have been reported across all scales, ranging from .88 to .9584
Exclusion Criteria
- Major neurocognitive disorder, including due to TBI
- The adapted Ohio State Traumatic Brain Injury Identification Method (OSU TBI-ID), is a 3-5 min. clinician administered interview for lifetime history of TBI
- The OSU TBI-ID is a recommended common data element by NIH and evidences good- excellent reliability and validity
- The OSU TBI-ID will be used to identify severe TBI as defined as a score of 5
- The participant's medical record may also be used for secondary verification in the case of TBI
- For those scoring a 5, further referral and screening for comprehension ability will be recommended to determine exclusion (as the intent is to identify individuals who may not understand or comprehend study materials)
- Untreated/poorly managed psychosis or substance dependence
- The Mini-International Diagnostic Interview (MINI), is a structured diagnostic interview that can be completed in less than 10 minutes
- It is one of the most widely used diagnostic interviews and evidences psychometric properties that are like more complex and lengthier measures
- The psychotic disorders and substance dependence subscales of the MINI will be used to screen for DSM-V criteria for current psychosis and substance dependence
- Participants meeting the diagnostic criteria above will be asked about their current treatment and if needed, the PI (licensed clinical psychologist) will speak with them regarding their current treatment plan and interest in referrals
- Those not engaged in treatment (diagnosis without ongoing medication management or psychotherapy) and/or evidencing need for referral to detox (e.g. symptoms of withdrawal), and/or evidencing symptoms that interfere with the intake assessment will be excluded and referred for treatment. Where possible, a warm handoff will always be provided
- Participants will be welcomed back to the study once stabilized
- Current suicide risk
- The Beck Depression Inventory-II (BDI-II), a 21-item self-report measure of depression symptoms (5 min. to complete), will be used to assess for suicide risk as defined as a score of 2 or more on the BDI-II suicide item
- The BDI-II suicide item evidences a moderate correlation with the other scales of suicidal ideation in clinical samples, and has predictive validity
- Follow-up risk-assessment will be provided by the PI who is a licensed clinical
Data sourced from ClinicalTrials.gov (NCT03403153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.