Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05397691
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2022-05-23
Brief Title:
Substance Use Prevention for Youth With Parents in Recovery
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
Substance Use Prevention for Youth With Parents in Recovery A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Risk for substance use disorder SUD begins early in the life course Although preventing and decreasing illicit and nonmedical drug use among youth is an urgent public health priority there are currently few evidence-based prevention strategies feasible for delivery in the primary care setting The investigators propose a three-year plan to collect critical pilot data to pilot test and optimize a dyadic intervention that aims to increase family resilience strengthen coping skills help families plan for the future and prevent youth SUD
The prototype for the intervention approach is Family Talk an evidence-based parent-youth dyadic intervention that can be delivered within the existing infrastructure of the patient-centered medical home The investigators have made preliminary adaptations to the model in preparation for testing To prepare for a subsequent efficacy study a two-arm pilot randomized controlled trial of the intervention with 40 parent-youth dyads to optimize the intervention model will be conducted The feasibility of the intervention will be evaluated In addition empiric estimates of study parameters to inform the planning of a fully powered randomized controlled trial and plausible intervention targets using semi-structured qualitative interviews will be obtained
The prototype for the intervention approach is Family Talk an evidence-based parent-youth dyadic intervention that can be delivered within the existing infrastructure of the patient-centered medical home The investigators have made preliminary adaptations to the model in preparation for testing To prepare for a subsequent efficacy study a two-arm pilot randomized controlled trial of the intervention with 40 parent-youth dyads to optimize the intervention model will be conducted The feasibility of the intervention will be evaluated In addition empiric estimates of study parameters to inform the planning of a fully powered randomized controlled trial and plausible intervention targets using semi-structured qualitative interviews will be obtained
Detailed Description:
Within the context of a pilot randomized controlled trial the objectives are to 1 Optimize the content and delivery of the intervention through an iterative series of quality improvement cycles informed by structured feedback from parents youth and intervention providers after each session 2 Field test study logistics including participant recruitment willingness to consent to a randomized trial loss to follow-up the acceptability and feasibility of the study measures and 3 Obtain empiric estimates of study parameters to inform future clinical trial design including within-group standard deviation of continuous measures correlations of repeated measures and proportion of control group subjects who experience each outcome The products at the end of the pilot study will be an optimized intervention model developed with parent and youth input and ready for efficacy testing and a set of putative intervention targets ready to be tested in the subsequent trial The ultimate goal is to develop an effective approach to youth substance use prevention delivered within the infrastructure of the patient-centered medical home If successful this trajectory of work has the potential to identify a novel family-centered approach to substance use disorder prevention for a high-risk population of youth whose parents are in recovery
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 |
|---|---|---|---|
| 1R34DA052836-01A1 | NIH | None | httpsreporternihgovquickSearch1R34DA052836-01A1 |