Examining Whether Project Support Works
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Project Support, Case Management Services.
- Who it may be relevant to
- Registry conditions: Parent-Child Relations, Parenting Self Efficacy, Child Mental Health. Basic parameters: 6 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial of Project Support
Overview
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.
Detailed 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.
Interventions
- Behavioral 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 - Behavioral 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 measures
- 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]
Secondary outcome measures (2)
- Child psychological distress assessed by the Pediatric Symptom Checklist [Time frame: Baseline to Post-test (6 weeks)]
- Child self-blame appraisals assessed by the Child Attributions and Perceptions Scale (CAPS) [Time frame: Baseline to Post-test (6 weeks)]
Eligibility 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT06963554 · Pro00144297