Viewing Study NCT06391229



Ignite Creation Date: 2024-05-06 @ 8:27 PM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06391229
Status: RECRUITING
Last Update Posted: 2024-07-09
First Post: 2024-04-22

Brief Title: Examine the Feasibility and Acceptability of Project Support
Sponsor: Medical University of South Carolina
Organization: Medical University of South Carolina

Study Overview

Official Title: A Brief Intervention to Enhance Supportive Parenting and Treatment Engagement Among Families Waiting for Trauma-Focused Services
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
K99HD111677 NIH None httpsreporternihgovquickSearchK99HD111677