Clinical trial NCT06963554: Examining Whether Project Support Works
Official title: Randomized Controlled Trial of Project Support
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Parenting Self Efficacy
Child Mental Health
Keywords: Child trauma
Non-offending caregiver
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Parenting self-efficacy assessed by the Tool to Measure Parenting Self-Efficacy (TOPSE)
timeFrame: Baseline to Post-test (6 weeks)
measure: Supportive parenting assessed by the Parent Behavior Inventory
timeFrame: Baseline to Post-test (6 weeks)
measure: Attendance to trauma-focused treatment intake session coded from clinical records
timeFrame: 4 months after Post-test
Secondary outcomes:
measure: Child psychological distress assessed by the Pediatric Symptom Checklist
timeFrame: Baseline to Post-test (6 weeks)
measure: Child self-blame appraisals assessed by the Child Attributions and Perceptions Scale (CAPS)
timeFrame: Baseline to Post-test (6 weeks)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Caitlin Rancher, PhD
role: PRINCIPAL_INVESTIGATOR
References: