Recruiting

Project Support

Sponsor:

Medical University of South Carolina

Code:

NCT06963554

Conditions

Parent-Child Relations

Parenting Self Efficacy

Child Mental Health

Eligibility Criteria

Sex: All

Age: 6 - 13

Healthy Volunteers: Not accepted

Interventions

Project Support

Case Management Services

Study Details

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.

Conditions

Parent-Child Relations

Parenting Self Efficacy

Child Mental Health

Study ID

NCT06963554

Start date

Nov 4, 2025

Status verified date

Jun, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 13

Healthy Volunteers: Not accepted

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 or Spanish;
  • Child has been living with caregiver for 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Project Support

All participants will complete a baseline assessment on demographics, parenting behaviors, and mental health symptoms. Participants randomized to the experimental condition will receive Project Support and be offered case management services. Approximately 4-6 weeks after the baseline assessment all participants will complete a post-test assessment that includes measures of service satisfaction.

other: Treatment as usual

All participants will complete a baseline assessment on demographics, parenting behaviors, and mental health symptoms. Participants randomized to the treatment as usual condition will receive routine provision of case management services. Approximately 4-6 weeks after the baseline assessment all participants will complete a post-test assessment that includes measures of service satisfaction.

Interventions

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.

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.

Primary outcome measure

  • Parenting self-efficacy assessed by the Tool to Measure Parenting Self-Efficacy (TOPSE) [ Time Frame: Baseline to Post-test (6 weeks) ]
  • Supportive parenting assessed by the Parent Behavior Inventory [ Time Frame: Baseline to Post-test (6 weeks) ]
  • Attendance to trauma-focused treatment intake session coded from clinical records [ Time Frame: 4 months after Post-test ]

Central Contacts and Locations

Central contacts

Caitlin Rancher, PhD

843-608-0491rancher@musc.edu

Research Coordinator

projectsupport@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator

843-608-0491rancher@musc.edu

Principal Investigator:

Caitlin Rancher, PhD

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Child trauma
  • Non-offending caregiver

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-06-09.