Clinical trial NCT05397691: Substance Use Prevention for Youth With Parents in Recovery
Official title: Substance Use Prevention for Youth With Parents in Recovery: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Keywords: Family Talk
Parent-youth dyad
Family functioning
Coping strategies
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2022-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria for youth:

* 12-18 years without diagnosed SUD
* Comfortable speaking English or Spanish

Inclusion Criteria for parent:

* 18 years or older
* Receiving treatment for SUD
* Receiving substance use care in the CODAC system
* Comfortable speaking English or Spanish

Exclusion Criteria:

* Presence of acute family crisis, such as recent death, incarceration, separation, divorce, or other stressor
* Parent or youth with cognitive limitation or intellectual disability

Primary outcomes:
measure: Participation metrics
timeFrame: 12 months
measure: Reasons for not enrolling
timeFrame: 12 months
measure: Study attrition rates
timeFrame: 12 months
measure: Number of sessions
timeFrame: throughout the study up to 12 months
measure: Person-time of sessions
timeFrame: throughout the study up to 12 months
Secondary outcomes:
measure: Youth substance use in preceding 90 days
timeFrame: 90 days
measure: Youth substance use screening
timeFrame: 12 months
measure: Family Communication
timeFrame: 3 months, 6 months, 12 months
measure: Family Functioning
timeFrame: 3 months, 6 months, 12 months
measure: Depression
timeFrame: 3 months, 6 months, 12 months
measure: Perceived Stress
timeFrame: 3 months, 6 months, 12 months
measure: Problem solving skills
timeFrame: 3 months, 6 months, 12 months
measure: Self-efficacy coping strategies
timeFrame: 3 months, 6 months, 12 months
measure: Types of coping strategies
timeFrame: 3 months, 6 months, 12 months
measure: Social support
timeFrame: 3 months, 6 months, 12 months
measure: Youth perceptions of peer, sibling, parental substance use
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: CODAC
state: Rhode Island
Study officials:
affiliation: Brown University School of Public Health
name: Caroline J Kistin, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: