Examining Whether Project Support Works

NCT06963554 | Recruiting DMC

• 1 other identifier: Pro00144297
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Child trauma; Non-offending caregiver

Outcome Measures

Primary Outcomes (3)

• Parenting self-efficacy assessed by the Tool to Measure Parenting Self-Efficacy (TOPSE)

  Caregivers will complete the Tool to Measure Parenting Self-Efficacy (TOPSE). Responses to this questionnaire assess several domains of parenting. Responses to items assessing parenting self-efficacy (e.g., "I am able to comfort my child") are made on a 11-point scale (0 = completely disagree, 10 = completely agree). Responses are summed to create a total score. This outcome measure will be assessed by comparing both within- and between-person changes in parenting self-efficacy from baseline to post-test.

  Baseline to Post-test (6 weeks)

• Supportive parenting assessed by the Parent Behavior Inventory

  Caregivers and children will complete convergent versions of the Parent Behavior Inventory. Responses to this questionnaire assess several domains of parenting. Responses to items assessing supportive/engaged parenting (e.g., "I listen to \_\_\_'s feelings and try to understand them") are made on a 6-point scale (0 = not at all true to 5 = very true). Responses are summed to create a total score. This outcome measure will be assessed by comparing within- and between-person changes in supportive parenting from baseline to post-test.

  Baseline to Post-test (6 weeks)

• Attendance to trauma-focused treatment intake session coded from clinical records

  Research staff will review clinical records to determine whether participants attended their intake session. This will be coded dichotomously as whether or not the family attends the intake appointment ( 0 = did not attend intake, 1 = attended intake). Families will be determined to have attended their intake if this is noted either in clinic records as "in treatment" or if there is an "intake note" available in the clinical record. We will monitor the status of intake attendance for up to 4 months after the family completes participation in the post-test assessment.

  4 months after Post-test

Secondary Outcomes (2)

• Child psychological distress assessed by the Pediatric Symptom Checklist

  Baseline to Post-test (6 weeks)

• Child self-blame appraisals assessed by the Child Attributions and Perceptions Scale (CAPS)

  Baseline to Post-test (6 weeks)

Study Arms (2)

Project Support

EXPERIMENTAL

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.

Behavioral: Project Support; Behavioral: Case Management Services

Treatment as usual

OTHER

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.

Behavioral: Case Management Services

Interventions

Project Support BEHAVIORAL

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.

Project Support

Case Management Services BEHAVIORAL

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.

Project Support; Treatment as usual

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Study Officials

• Caitlin Rancher, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin Rancher, PhD

CONTACT

843-608-0491; rancher@musc.edu

Research Coordinator

CONTACT

projectsupport@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 9, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: November 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)