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Clinical Trials/NCT02622451
NCT02622451
Completed
N/A

Differential Sensitivity Markers in Youth Drug Abuse Prevention

University of Minnesota1 site in 1 country32 target enrollmentDecember 1, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Adolescent Substance Use
Sponsor
University of Minnesota
Enrollment
32
Locations
1
Primary Endpoint
Delayed Discounting Task
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This pilot study conducts feasibility and exploratory intervention outcome research that will lead to the development of a personalized intervention framework that seeks to preempt the progression from early drug use to more chronic abuse and dependency. The study will explore moderators representing two frameworks, risk severity and differential sensitivity. Moderators will be explored in their ability to influence the differential efficacy of two adolescent drug abuse interventions.

Detailed Description

This R34 pilot study proposes to conduct feasibility and exploratory intervention outcome research that will lead to the development of a personalized intervention framework for early stage adolescent drug users. The study will explore putative moderators representing two theoretically distinct frameworks and determine whether they are suitable candidates for a subsequent R01 study. One moderation framework is based on risk severity (RS) as reflected by individual differences in delay discounting (DD), a form of impulsive decision making that is positively associated with escalation to more serious levels of abuse and addiction. A second more exploratory framework is based on differential sensitivity (DS) theory. The DS framework stipulates that individuals, due to specific sensitivity factors, vary in their responsiveness to environmental influence such as the influence provided by an intervention. The study will explore DS markers associated with the reward motivational system, including dopaminergic genes, the post-auricular physiological reflex and a high sensory-processing sensitivity trait. An agency-university partnership will collaborate in providing services to 120 adolescents (ages 12-17) who were referred to a community counseling center because of a recent alcohol and/or marijuana incident. Recruitment will select mild/moderate drug users. Participants will be randomized to one of two evidence-based drug abuse interventions. The two interventions offer the same delivery dosage but differ in terms of their mechanism of therapeutic change (i.e., degree of environmental influence). The Teen Intervene program (TI; Winters \& Leitten, 2007) is a youth-focused intervention that uses motivational interviewing, goal setting, and skills training to foster the internal development of responsible decision-making with the goal of choosing attitudes and behaviors that are healthier alternatives to drug use behaviors. The Everyday Parenting program (EP; Dishion et al., 2003; 2010) is a family focused-intervention that works with parents to provide environmental scaffolding necessary to help teens gradually internalize decision-making skills that reinforce and promote healthy lifestyle alternatives to drug use. The aims of this R34 are to (1) assess feasibility of recruiting, assessing, and following-up enrolled youth in an intervention trial, (2) assess the ability of staff to implement TI and EP with fidelity, and (3) obtain promising data on moderator and outcome variables that will help answer the question of "what intervention works best for which youth" in a subsequent R01 study.

Registry
clinicaltrials.gov
Start Date
December 1, 2015
End Date
March 8, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Youth ages 12-17
  • Substance Use referral to community partner agency
  • Adolescent report of weekly-monthly use of one or more substances within the prior 6 months

Exclusion Criteria

  • Current DSM-5 diagnosis of a severe substance use disorder (i.e. substance dependence)
  • Adolescent report of daily use of substance within prior 6 months
  • Current or past history of psychosis (including suicidal ideation)
  • Pervasive developmental disabilities

Outcomes

Primary Outcomes

Delayed Discounting Task

Time Frame: 4 months post-intervention

Youth Computer Task

Iowa Gambling Task

Time Frame: 4 months post-intervention

Youth Computer Task

Urinalysis

Time Frame: 4 months post-intervention

Adolescents will provide urine samples for urinalysis to test for recent drug usage.

Peer Delinquency Scale

Time Frame: 4 months post-intervention

Youth Report

Project Towards No Drug Abuse Survey

Time Frame: 4 months post-intervention

Youth Report

Single-item self-efficacy Scale

Time Frame: 4 months post-intervention

Youth Report

Parental Monitoring Instrument

Time Frame: 4 months post-intervention

Parent \& Youth Report

Alcohol Expectancy Questionnaire

Time Frame: 4 months post-intervention

Youth Report

Parenting Relationship Questionnaire (PRQ)

Time Frame: 4 months post-intervention

Parent Report

Family Problem Solving Communication Index

Time Frame: 4 months post-intervention

Parent Report

Conflict Behavior Questionnaire

Time Frame: 4 months post-intervention

Parent Report

Peer Substance Use Test

Time Frame: 4 months post-intervention

Youth Report

Client Satisfaction Questionnaire

Time Frame: 4 months post-intervention

Parent \& Youth Report

Highly Sensitive Person Scale

Time Frame: 4 months post-intervention

Parent \& Youth Report

Family Assessment Measure - III

Time Frame: 4 months post-intervention

Parent Report on family functioning .

Parental Locus of Control Questionnaire

Time Frame: 4 months post-intervention

Parent Report

Study Sites (1)

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