Status:
COMPLETED
Parenting Strength At Home- Parents Pilot
Lead Sponsor:
VA Office of Research and Development
Conditions:
Parenting Behaviors and PTSD Symptoms
Eligibility:
All Genders
18+ years
Phase:
NA
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 Veter...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03403153
Start Date
March 1 2019
End Date
March 31 2022
Last Update
July 26 2024
Active Locations (3)
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1
Austin Information Technology Center, Austin, TX
Austin, Texas, United States, 78772
2
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, United States, 76504
3
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
Waco, Texas, United States, 76711