Examining Whether Project Support Works
- Conditions
- Parent-Child RelationsParenting Self EfficacyChild Mental Health
- Registration Number
- NCT06963554
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
This study will involve a randomized, controlled trial with two parallel groups, Project Support and a treatment as usual control group. Families with a child on the waitlist for trauma-focused services will be invited to participate. Participation involves completing a baseline assessment of family functioning and trauma characteristics. Participants will then be randomized to either Project Support or the treatment as usual control group. All participants will be invited to complete the post-test assessment 4-6 weeks after the baseline assessment, prior to beginning trauma-focused services.
- Detailed Description
The proposed research addresses the dearth of brief, empirically-supported programs designed for caregivers to mitigate the adverse effects of child trauma. This project will examine the telehealth delivery of Project Support, a program that addresses parenting skills and behavior problems among children exposed to violence or maltreatment. Project Support uses didactic, tailored instruction to teach caregivers how to listen to and comfort their child. This study builds on prior research which has found that Project Support is feasible and acceptable for both treatment providers and families on the waitlist for trauma-focused services. This phase of the research will examine the preliminary efficacy of Project Support in a randomized controlled trial, evaluating the impact of this intervention on caregiver emotional support, parenting self-efficacy, and family distress, compared to treatment as usual.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Family is seeking trauma-focused services for their child;
- Child is between 6 - 13 years old;
- Caregiver agreed to be contacted for volunteer research opportunities;
- Caregiver and child can communicate in English;
- Child has been living with caregiver for at the last 6 months or longer;
- Family is able to participate in services delivered via telehealth.
- Child or caregiver has a diagnosis that would impair their ability to participate in or benefit from services (e.g., traumatic brain injury, developmental disability, psychosis);
- Child is in Foster Care or Department of Social Services custody;
- The caregiver is unwilling or unable to give informed consent and/or the child is unwilling and unable to give assent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Parenting self-efficacy assessed by the Tool to Measure Parenting Self-Efficacy (TOPSE) Baseline to Post-test (6 weeks) Caregivers will complete the Tool to Measure Parenting Self-Efficacy (TOPSE). Responses to this questionnaire assess several domains of parenting. Responses to items assessing parenting self-efficacy (e.g., "I am able to comfort my child") are made on a 11-point scale (0 = completely disagree, 10 = completely agree). Responses are summed to create a total score. This outcome measure will be assessed by comparing both within- and between-person changes in parenting self-efficacy from baseline to post-test.
Supportive parenting assessed by the Parent Behavior Inventory Baseline to Post-test (6 weeks) Caregivers and children will complete convergent versions of the Parent Behavior Inventory. Responses to this questionnaire assess several domains of parenting. Responses to items assessing supportive/engaged parenting (e.g., "I listen to ___'s feelings and try to understand them") are made on a 6-point scale (0 = not at all true to 5 = very true). Responses are summed to create a total score. This outcome measure will be assessed by comparing within- and between-person changes in supportive parenting from baseline to post-test.
Attendance to trauma-focused treatment intake session coded from clinical records 4 months after Post-test Research staff will review clinical records to determine whether participants attended their intake session. This will be coded dichotomously as whether or not the family attends the intake appointment ( 0 = did not attend intake, 1 = attended intake). Families will be determined to have attended their intake if this is noted either in clinic records as "in treatment" or if there is an "intake note" available in the clinical record. We will monitor the status of intake attendance for up to 4 months after the family completes participation in the post-test assessment.
- Secondary Outcome Measures
Name Time Method Child psychological distress assessed by the Pediatric Symptom Checklist Baseline to Post-test (6 weeks) Caregivers and children will complete convergent versions of the Pediatric Symptom Checklist. Responses to items on this questionnaire measuring child psychological distress (e.g., "Feels sad, unhappy") are made on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Responses are summed to create a total score, with higher scores indicating greater psychological distress. This outcome measure will be assessed by comparing within and between-person changes in child psychological distress from baseline to post-test.
Child self-blame appraisals assessed by the Child Attributions and Perceptions Scale (CAPS) Baseline to Post-test (6 weeks) Children will complete the Child Attributions and Perceptions Scale (CAPS) assessing their self-blame appraisals (e.g., "Do you blame yourself when things go wrong?") on a 5-point scale (1 = never to 5 = always). Responses are summed to create a total score, with higher scores indicating greater self-blame. This outcome measure will be assessed by comparing within- and between-person change from baseline to post-test.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States