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NCT Number: NCT06963554

Examining Whether Project Support Works

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.

Recruiting

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Key information

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Caitlin Rancher, PhD

PRINCIPAL_INVESTIGATOR

Principal Investigator

CONTACT

[email protected]

843-608-0491

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline to Post-test (6 weeks)

    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.

  2. Supportive parenting assessed by the Parent Behavior Inventory

    Time frame: Baseline to Post-test (6 weeks)

    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.

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

    Time frame: 4 months after Post-test

    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.

Secondary outcomes

  1. Child psychological distress assessed by the Pediatric Symptom Checklist

    Time frame: Baseline to Post-test (6 weeks)

    Caregivers and children will complete convergent versions of the Pediatric Symptom Checklist. Responses to items on this questionnaire measuring child psychological distress (e.g., "Feels sad, unhappy") are made on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Responses are summed to create a total score, with higher scores indicating greater psychological distress. This outcome measure will be assessed by comparing within and between-person changes in child psychological distress from baseline to post-test.

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

    Time frame: Baseline to Post-test (6 weeks)

    Children will complete the Child Attributions and Perceptions Scale (CAPS) assessing their self-blame appraisals (e.g., "Do you blame yourself when things go wrong?") on a 5-point scale (1 = never to 5 = always). Responses are summed to create a total score, with higher scores indicating greater self-blame. This outcome measure will be assessed by comparing within- and between-person change from baseline to post-test.

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Rancher, PhD

CONTACT

[email protected]

843-608-0491

Research Coordinator

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Randomized Controlled Trial of Project Support

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 9, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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