Clinical trial NCT03403153: Parenting Strength At Home- Parents Pilot
Official title: Adaptation, Refinement, and Open Trial of Parent Training for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting Behaviors and PTSD Symptoms
Keywords: Parent-Child Relationship
military family
veterans health
stress disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-01-18
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is examining the feasibility and acceptability of an intervention to improve parent-child functioning. It will also conduct a preliminary test for movement in target outcomes.
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

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 psychologist
  * Individuals will be eligible after crisis intervention has been received

Primary outcomes:
measure: Client Satisfaction Questionnaire-8 (CSQ; Attkisson & Greenfield, 2004)
timeFrame: 8 weeks
measure: Strength at Home Parents Specific Satisfaction Questionnaire
timeFrame: 8 weeks
measure: The Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
timeFrame: 8 weeks
Secondary outcomes:
measure: The Parenting Stress Index, 4th Edition (PSI; Abidin, 2012)
timeFrame: 8 weeks
measure: The Family Assessment Device General Family Functioning Scale (FAD; Epstein, Baldwin, & Bishop, 1983)
timeFrame: 8 weeks
measure: The Pediatric Symptom Checklist (PSC; Jellinek, et al., 1986)
timeFrame: 8 weeks
measure: The Parenting Scale Laxness Subscale
timeFrame: 8 weeks
measure: Beck Depression Inventory-II (BDI-II; Beck et al. 1996)
timeFrame: 8 weeks
measure: PTSD Checklist for DSM-5 (PCL-5; Weathers et al. 2013)
timeFrame: 8 weeks
measure: Parenting Stress Index Hostility Subscale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Information Technology Center, Austin, TX
state: Texas
city: Temple
country: United States
facility: Central Texas Veterans Health Care System, Temple, TX
state: Texas
city: Waco
country: United States
facility: Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
state: Texas
Study officials:
affiliation: Central Texas Veterans Health Care System, Temple, TX
name: Suzannah K. Creech, PhD
role: PRINCIPAL_INVESTIGATOR
References: