NCT06963554

Examining Whether Project Support Works

Randomized Controlled Trial of Project Support

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parent-Child Relations
• Parenting Self Efficacy
• Child Mental Health

Interventions

Type	Name	Description
BEHAVIORAL	Project Support	The Project Support intervention involves up to four 60-minute individual counseling sessions focused on teaching caregivers how to listen to and comfort their child. Participants will receive didactic instruction and feedback on their use of the skills in role-plays with a treatment provider and with their child. In the role-plays the provider first demonstrates how to use the skill in a brief example of typical situations in which the skill could be used. In these examples the caregiver takes on the role of their child and the provider takes on the role of the caregiver. Subsequently the caregiver and provider switch roles so the caregiver has an opportunity to practice executing the skill. The provider helps the caregiver process their experience of each role-play and provides real-time, targeted feedback to help the caregiver develop their ability to use the skills.
BEHAVIORAL	Case Management Services	Case management services, or treatment as usual, may involve referrals for financial resources or donated goods, as well as assistance with court, law enforcement, or information about orders of protection. The nature of these services depends on the needs identified by the family and case manager. There is currently no standard "treatment" offered to families on the waitlist. This condition will receive individually tailored services, as needed.

Timeline

• Start date: 2025-11-04
• Primary completion: 2027-11-01
• Completion: 2028-03-31
• First posted: 2025-05-09
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States