Differential Sensitivity Markers in Youth Drug Abuse Prevention

NCT ID: NCT02622451

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2020-03-08

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.

Conditions

Adolescent Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Youth Behavioral Intervention

Teen Intervene

Group Type: OTHER

Teen Intervene

Intervention Type: BEHAVIORAL

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.

Parent Education

Everyday Parenting

Group Type: OTHER

Everyday Parenting

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Natalis Counseling Center

UNKNOWN

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerald August, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Center for Personalized Prevention Research in Children's Mental Health

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

R34DA037888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1504S69041

Identifier Type: -

Identifier Source: org_study_id