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Examine the Feasibility and Acceptability of Project Support

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Parenting
Parent-Child Relations
Child Mental Disorder

Treatments

Behavioral: Project Support

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06391229
Pro00136524
K99HD111677 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

32 patients

Sex

All

Ages

5 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

Project Support
Experimental group
Description:
All caregivers will receive the Project Support intervention over the course of 4-6 weeks.
Treatment:
Behavioral: Project Support

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Caitlin Rancher, PhD

Data sourced from clinicaltrials.gov

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