Examine the Feasibility and Acceptability of Project Support

NCT06391229 | Completed DMC

• 2 other identifiers: Pro00136524K99HD111677
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will conduct a proof-of-concept pilot trial of delivering the Project Support Positive Parenting Module (Project Support) to n = 30 families waiting for trauma-focused services. Investigators hypothesize that Project Support will be feasible and acceptable as evidenced by benchmarks for recruitment, retention at post assessment, engagement, fidelity, and program satisfaction. Investigators will also explore trends on caregiver emotional support, parenting self-efficacy, and child mental health symptoms.

Conditions

Parent-Child Relations; Parenting; Child Mental Disorder

Keywords

Non-offending caregiver; Child trauma

Outcome Measures

Primary Outcomes (3)

• Supportive Parenting assessed by the Alabama Parenting Questionnaire

  Caregivers and children will complete convergent versions of the Alabama Parenting Questionnaire. Responses to this questionnaire assess several domains of parenting. Responses to items assessing supportive parenting (e.g,. "you praise your child if he/she behaves well") are made on a 5-point scale (0 = never, 1 = almost never, 2 = sometime, 3 = often, 4 = always). Responses are summed to create a total score. Higher scores of supportive parenting measured on the Alabama Parenting Questionnaire have previously been associated with lower levels of child behavior problems. This outcome measure will be assessed by comparing within-person mean levels of supportive parenting from baseline to post-test.

  Baseline to Post-test (6 weeks)

• Parenting self-efficacy assessed by the Parenting Sense of Competence Scale

  Caregivers will complete the parenting self-efficacy subscale of the Parenting Sense of Competence Scale. Responses to items on this questionnaire measuring self-efficacy (e.g., "If anyone can find the answer to what is troubling my child, I am the one") are made on a 6-point scale (1 = strongly disagree to 6 = strongly agree). Responses are summed to create a total score. Higher scores on the self-efficacy subscale have been associated with lower levels of child externalizing problems. This outcome measure will be assessed by comparing within-person mean levels of parenting self-efficacy from baseline to post-test.

  Baseline to Post-test (6 weeks)

• Hopefulness assessed by the Beck Hopelessness Scale-4

  Caregivers will complete the Beck Hopelessness Scale-4. Responses to items on this questionnaire measuring hopelessness (e.g., "I feel the future is hopeless and that things cannot improve") are made on a 4-point scale (0 = not typical, 1 = rarely typical, 2 = typical, 3 = very typical). Responses are summed to create a total score, with higher scores indicating greater hopelessness. The Beck Hopelessness Scale-4 has demonstrated robust internal reliability, coefficient alphas = .84-.88. This outcome measure will be assessed by comparing within-person mean levels of hopelessness from baseline to post-test.

  Baseline to Post-test (6 weeks)

Secondary Outcomes (1)

• Child psychological distress assessed by the Pediatric Symptom Checklist

  Baseline to Post-test (6 weeks)

Study Arms (1)

Project Support

EXPERIMENTAL

All caregivers will receive the Project Support intervention over the course of 4-6 weeks.

Behavioral: Project Support

Interventions

Project Support BEHAVIORAL

Caregivers will receive up to four, 60- to 90-minute sessions focused on teaching two parenting skills - attentive listening and comforting. Attentive listening involves providing accurate and timely responses to show interest and keep the child engaged until they are ready to end the conversation. Comforting involves using the same attentive listening skills when the child is upset or distressed. Effective mastery of the listening and comforting skills also requires caregivers to withhold any non-listening or non-comforting responses (e.g., interruptions, criticisms). The program is individually tailored such that caregivers with stronger skills could complete the program in less time (i.e., fewer sessions). Service providers educate caregivers about the skills, then engage in an iterative process of modeling the skills, engaging the caregivers in behavioral practice, and providing tailored, supportive feedback to help caregivers gain mastery.

Also known as: Project Support Positive Parenting Module

Project Support

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Family is seeking trauma-focused services for their child as measured by their placement on the waitlist for services at the National Crime Victims Center;
• Child is between 5 - 12 years old;
• Caregiver agreed to be contacted for volunteer research opportunities;
• Caregiver and child can communicate in either English or Spanish;
• 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)

National Crime Victims Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Caitlin Rancher, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 30, 2024
• Study Start: July 2, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)