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Completed

NCT Number: NCT06391229

Examine the Feasibility and Acceptability of Project Support

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Crime Victims Center

Charleston, South Carolina, 29425, United States

About this study

Over two-thirds of children experience traumatic events such as child maltreatment, violence, or sudden or violent loss. Many of these children sustain significant emotional and developmental difficulties including trauma symptoms, aggression, and suicidality. Emotional support from a caregiver is theorized to buffer against the effects of trauma; however, many caregivers lack the self-efficacy and skills to effectively support their child, or struggle to apply these skills during the stressful time following trauma. Unfortunately, programs designed for caregivers following child trauma are scarce. Existing interventions are lengthy (lasting 8-20 sessions) and result in families placed on long waitlists. This proposal asserts the adverse effects of child trauma can be interrupted though a brief intervention (the Project Support Positive Parenting Module) that enhances supportive parenting - delivered via telehealth to families on waitlists for trauma-focused services. In this study, Investigators will conduct a proof-of-concept pilot trial with 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. Long-term, this research will generate an effective intervention that addresses the needs of families affected by trauma, which can be scaled up to address other public health epidemics that impede supportive parenting and child development.

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 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.

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

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.

Other names: Project Support Positive Parenting Module

Primary outcomes

  1. Supportive Parenting Assessed by the Alabama Parenting Questionnaire

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

    Supportive Parenting scale includes 3 items (e.g,. "you praise your child if he/she behaves well") made on a 5-point scale (0 = never, 1 = almost never, 2 = sometime, 3 = often, 4 = always). Scale ranges from 0 to 12. Item responses are summed. Higher scores indicate a better outcome of more supportive parenting.

  2. Parenting Self-efficacy Assessed by the Parenting Sense of Competence Scale

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

    Parenting self-efficacy subscale includes 8 items (e.g., "If anyone can find the answer to what is troubling my child, I am the one") made on a 6-point scale (1 = strongly disagree to 6 = strongly agree). Scale ranges from 8 to 48. Item responses are summed. Higher scores indicate better outcome of greater parenting self-efficacy.

  3. Hopefulness Assessed by the Beck Hopelessness Scale-4

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

    The Beck Hopelessness Scale-4 includes 4 items measuring hopelessness (e.g., "I feel the future is hopeless and that things cannot improve") made on a 4-point scale (0 = not typical, 1 = rarely typical, 2 = typical, 3 = very typical). Scale ranges from 0 to 12. Item responses are summed. Higher scores indicate worse outcomes in that they represent a higher degree of hopelessness.

Secondary outcomes

  1. Child Psychological Distress Assessed by the Pediatric Symptom Checklist

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

    The total problems scale on the Pediatric Symptom Checklist includes 17 items measuring child psychological distress (e.g., "Feels sad, unhappy") made on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Scale ranges from 0 to 34. Item responses are summed. Higher scores indicate worse outcomes in that they represent higher psychological distress.

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

A Brief Intervention to Enhance Supportive Parenting and Treatment Engagement Among Families Waiting for Trauma-Focused Services

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2024
Registry last updated
Jul 15, 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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