Actively Recruiting
Randomized Controlled Trial of Project Support Delivered via Telehealth for Families with Children Awaiting Trauma-Focused Services
Led by Medical University of South Carolina · Updated on 2025-11-06
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on families with children aged 6 to 13 years who are awaiting trauma-focused services. It evaluates Project Support, a program aimed at helping caregivers improve parenting skills and reduce the negative effects of child trauma. The study compares Project Support delivered via telehealth with usual case management services, assessing impacts on caregiver emotional support, parenting confidence, and family distress. Participants are randomly assigned to one of two groups: one receives Project Support, which includes up to four one-hour counseling sessions teaching caregivers how to listen to and comfort their child through guided role-plays and feedback. The other group receives routine case management services tailored to family needs, such as referrals and assistance with legal or financial issues. Both groups complete baseline and post-test assessments about 4-6 weeks apart. Families will take part in assessments measuring parenting behaviors, mental health symptoms, and satisfaction with services before and after the intervention. Researchers will also track attendance to trauma-focused treatment sessions up to four months after the post-test. The study uses questionnaires and clinical records to evaluate outcomes related to parenting self-efficacy, supportive parenting, and child psychological distress. Participation lasts through these assessments and follow-up periods.
CONDITIONS
Brief Title
Examining Whether Project Support Works
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Family is seeking trauma-focused services for their child
- Child is between 6 and 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 least the last 6 months
- Family is able to participate in services delivered via telehealth
You will not qualify if you...
- 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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) for eligibility assessment
Duration - 4 to 6 weeks
Participants randomized to the experimental group receive up to four 60-minute individual telehealth counseling sessions focused on teaching caregivers how to listen to and comfort their child. Participants in the control group receive routine case management services tailored to family needs.
Up to 4 telehealth sessions for the experimental group; case management as needed for control group
Duration - Post-test at 4 to 6 weeks after baseline
Participants complete a post-test assessment approximately 4 to 6 weeks after baseline to evaluate parenting behaviors and mental health outcomes.
1 assessment visit (in-person or virtual)
Duration - 4 months after post-test
Attendance to trauma-focused treatment intake session is tracked 4 months after the post-test assessment to evaluate longer-term outcomes.
No visits; data collected from clinical records
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
C
Caitlin Rancher, PhD
R
Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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