Project Support for caregivers of children exposed to violence or maltreatment
Randomized Controlled Trial of Project Support
This trial tests whether a brief telehealth program called Project Support helps caregivers of 6–13-year-old children on a trauma-services waitlist improve parenting support and reduce family distress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 13 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06963554 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled trial comparing Project Support delivered by telehealth to a treatment-as-usual control group with two parallel arms. Caregivers of children aged 6–13 who are on a waitlist for trauma-focused services will complete a baseline assessment of family functioning and trauma characteristics and then be randomized. Participants assigned to Project Support will receive didactic, tailored instruction to improve listening, comforting, and parenting skills; all participants will complete a post-test 4–6 weeks after baseline before beginning trauma-focused services. The trial will compare changes in caregiver emotional support, parenting self-efficacy, and family distress between the Project Support and control groups to estimate preliminary efficacy.
Who should consider this trial
Good fit: Caregivers and their children aged 6–13 who are seeking trauma-focused services, have lived together for at least six months, can communicate in English, agreed to be contacted for research, and can participate via telehealth are ideal candidates.
Not a fit: Children or caregivers with conditions that impair participation or benefit (for example severe developmental disability, traumatic brain injury, psychosis) or children in foster care/department of social services custody may not benefit or be eligible.
Why it matters
Potential benefit: If successful, caregivers may gain confidence and practical skills to better support their child, reducing family distress while waiting for trauma-focused services.
How similar studies have performed: Prior pilot and feasibility work has shown Project Support is acceptable and feasible for providers and families on waitlists, but randomized evidence of telehealth delivery is limited and this trial provides preliminary efficacy data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Caitlin Rancher, PhD — Medical University of South Carolina
- Study coordinator: Caitlin Rancher, PhD
- Email: rancher@musc.edu
- Phone: 843-608-0491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.