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Completed

NCT Number: NCT02622451

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.

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Key information

Conditions

Adolescent Substance Use

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Personalized Prevention Research in Children's Mental Health

Minneapolis, Minnesota, 55415, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teen Intervene

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.

Everyday Parenting

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.

Primary outcomes

  1. Delayed Discounting Task

    Time frame: 4 months post-intervention

    Youth Computer Task

  2. Iowa Gambling Task

    Time frame: 4 months post-intervention

    Youth Computer Task

  3. Urinalysis

    Time frame: 4 months post-intervention

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

  4. Peer Substance Use Test

    Time frame: 4 months post-intervention

    Youth Report

  5. Peer Delinquency Scale

    Time frame: 4 months post-intervention

    Youth Report

  6. Project Towards No Drug Abuse Survey

    Time frame: 4 months post-intervention

    Youth Report

  7. Alcohol Expectancy Questionnaire

    Time frame: 4 months post-intervention

    Youth Report

  8. Single-item self-efficacy Scale

    Time frame: 4 months post-intervention

    Youth Report

  9. Client Satisfaction Questionnaire

    Time frame: 4 months post-intervention

    Parent & Youth Report

  10. Highly Sensitive Person Scale

    Time frame: 4 months post-intervention

    Parent & Youth Report

  11. Parental Monitoring Instrument

    Time frame: 4 months post-intervention

    Parent & Youth Report

  12. Parenting Relationship Questionnaire (PRQ)

    Time frame: 4 months post-intervention

    Parent Report

  13. Family Problem Solving Communication Index

    Time frame: 4 months post-intervention

    Parent Report

  14. Parental Locus of Control Questionnaire

    Time frame: 4 months post-intervention

    Parent Report

  15. Family Assessment Measure - III

    Time frame: 4 months post-intervention

    Parent Report on family functioning .

  16. Conflict Behavior Questionnaire

    Time frame: 4 months post-intervention

    Parent Report

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Natalis Counseling Center
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2015
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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