Differential Sensitivity Markers in Youth Drug Abuse Prevention

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Substance Use
• Intervention / Treatment: Behavioral: Teen Intervene; Behavioral: Everyday Parenting

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Center for Personalized Prevention Research in Children's Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Youth Behavioral Intervention; Teen Intervene	Behavioral: Teen Intervene; Teen Intervene (TI) is an early intervention program for 12-19 year olds who display early stages of alcohol or drug use. TI uses motivational interviewing, goal setting, and skill 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.
Other: Parent Education; Everyday Parenting	Behavioral: Everyday Parenting; Everyday Parenting 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed Discounting Task	Youth Computer Task	4 months post-intervention
Iowa Gambling Task	Youth Computer Task	4 months post-intervention
Urinalysis	Adolescents will provide urine samples for urinalysis to test for recent drug usage.	4 months post-intervention
Peer Substance Use Test	Youth Report	4 months post-intervention
Peer Delinquency Scale	Youth Report	4 months post-intervention
Project Towards No Drug Abuse Survey	Youth Report	4 months post-intervention
Alcohol Expectancy Questionnaire	Youth Report	4 months post-intervention
Single-item self-efficacy Scale	Youth Report	4 months post-intervention
Client Satisfaction Questionnaire	Parent & Youth Report	4 months post-intervention
Highly Sensitive Person Scale	Parent & Youth Report	4 months post-intervention
Parental Monitoring Instrument	Parent & Youth Report	4 months post-intervention
Parenting Relationship Questionnaire (PRQ)	Parent Report	4 months post-intervention
Family Problem Solving Communication Index	Parent Report	4 months post-intervention
Parental Locus of Control Questionnaire	Parent Report	4 months post-intervention
Family Assessment Measure - III	Parent Report on family functioning .	4 months post-intervention
Conflict Behavior Questionnaire	Parent Report	4 months post-intervention

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute on Drug Abuse (NIDA); Natalis Counseling Center
• Investigators: Principal Investigator: Gerald August, Ph.D., University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): March 8, 2020
• Study Completion (Actual): March 8, 2020

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 1504S69041; R34DA037888 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No