Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604236
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2020-10-15
Brief Title:
Family Assessment Motivation and Linkage Intervention FAMLI
Sponsor:
Texas Christian University
Organization:
Texas Christian University
Study Overview
Official Title:
Increasing Family Engagement and Treatment Initiation Through Family Assessment Motivationand Linkage Intervention FAMLI
Status:
COMPLETED
Status Verified Date:
2023-09
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:
FAMLI
Brief Summary:
The R34 study will integrate existing tools for use with JJ populations and examine the feasibility acceptability and preliminary efficacy of a caregiver-youth intervention aimed at increasing SU treatment initiation The adaptive intervention incorporates three evidence-based components 1 assessment of motivation and linkage-related barriers with personalized feedback 2 Mapping-Enhanced Counseling MEC for improving readiness for change and interpersonal communication and 3 Active Linkage AL for addressing logistical barriers to service initiation Youth-caregiver dyads will be randomly assigned to receive an initial dose 2 1-hr sessions of either MEC or AL After 30 days participants will be classified as Responders 1 or more services initiated or Non-responders no service initiation All participants will be randomized to one of two intervening interventions an additional dose 2 1-hr sessions of the initial intervention MEC or AL or a different dose 2 1-hr sessions of the other The specific aims are to 1 integrate and adapt appropriate evidence-based intervention components as a dyadic intervention approach for JJ youth and caregivers 2 test the feasibility acceptability and optimal configuration of the dyadic intervention components and the protocol used to evaluate effectiveness including feasibility of recruitment implementation measurement and 3 preliminarily explore a whether an initial dose of MEC or AL is sufficient for promoting early initiation and engagement b whether an additional dose of MEC or AL or a change in dose is more effective and c which component sequence is most effective Primary outcomes include youth initiation of assessment or counseling counseling attendance and caregiver attendance at assessment first counseling andor family sessions measures Secondary outcomes include youth and caregiver attitudes problem recognition desire for help normative beliefs SU norms perceived control stressors and obstacles and youth SU self-report corroborated by UA results The study addresses the sizeable gap in service receipt among JJ youth by addressing family engagement and focuses on improving motivation to change linkage to services and treatment engagement
Detailed Description:
None
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