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Parenting Strength At Home- Parents Pilot (PSAH)

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ClinicalTrials.gov Identifier: NCT03403153
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease Intervention/treatment Phase
Parenting Behaviors and PTSD Symptoms Behavioral: SAHP Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Adaptation, Refinement, and Open Trial of Parent Training for Veterans With PTSD
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Pilot and Open Trial
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.





Primary Outcome Measures :
  1. Client Satisfaction Questionnaire-8 (CSQ) [ Time Frame: eight week ]
    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.

  2. Strength at Home Parents Specific Satisfaction Questionnaire [ Time Frame: eight week ]
    Veteran feedback will be elicited after sessions using an open-ended measure to assess satisfaction with SAHP strategies and content. Satisfaction will be evaluated via Veteran ratings of how helpful the session was, how helpful the homework was (0 = 'not at all helpful,' 8 = 'definitely helpful'), whether they learned anything during the session, and which components of each session were helpful or unhelpful. A modified version of this form will evaluate satisfaction with the MIA during the open trial.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Groups are gender-specific, meaning that the investigators will pilot the treatment in separate groups of women and men Veterans.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403153


Contacts
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Contact: Suzannah K Creech, PhD (254) 297-3025 Suzannah.Creech@va.gov
Contact: Kathryn Roe, BA (254) 297-3167 Kathryn.Roe@va.gov

Locations
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United States, Texas
Austin Information Technology Center, Austin, TX Recruiting
Austin, Texas, United States, 78772
Contact: Suzannah K Creech, PhD    254-297-3025      
Contact: John Kelley    2542973646    John.Kelley2@va.gov   
Central Texas Veterans Health Care System, Temple, TX Recruiting
Temple, Texas, United States, 76504
Contact: Suzannah K Creech, PhD    254-297-3025    Suzannah.Creech@va.gov   
Principal Investigator: Suzannah K. Creech, PhD         
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX Not yet recruiting
Waco, Texas, United States, 76711
Contact: Suzannah K Creech, PhD    254-297-3025      
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Suzannah K. Creech, PhD Central Texas Veterans Health Care System, Temple, TX

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03403153     History of Changes
Other Study ID Numbers: D2421-R
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 03/01/21-03/01/22
Access Criteria: Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication (guidance is provided on the ORD website).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Parent-Child Relationship
military family
veterans health
stress disorders