Clinical trial NCT06391229: Examine the Feasibility and Acceptability of Project Support
Official title: A Brief Intervention to Enhance Supportive Parenting and Treatment Engagement Among Families Waiting for Trauma-Focused Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Parenting
Child Mental Disorder
Keywords: Non-offending caregiver
Child trauma
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-04-30
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Supportive Parenting assessed by the Alabama Parenting Questionnaire
timeFrame: Baseline to Post-test (6 weeks)
measure: Parenting self-efficacy assessed by the Parenting Sense of Competence Scale
timeFrame: Baseline to Post-test (6 weeks)
measure: Hopefulness assessed by the Beck Hopelessness Scale-4
timeFrame: Baseline to Post-test (6 weeks)
Secondary outcomes:
measure: Child psychological distress assessed by the Pediatric Symptom Checklist
timeFrame: Baseline to Post-test (6 weeks)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: National Crime Victims Center
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Caitlin Rancher, PhD
role: PRINCIPAL_INVESTIGATOR
References: