Examining Whether Project Support Works

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Child Mental Health; Parenting Self Efficacy; Parent-Child Relations

Treatments: Behavioral: Case Management Services; Behavioral: Project Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06963554

Pro00144297

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Project Support

Experimental group

Description:

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.

Treatment:

Behavioral: Project Support

Behavioral: Case Management Services

Treatment as usual

Other group

Description:

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.

Treatment:

Behavioral: Case Management Services