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Differential Sensitivity Markers in Youth Drug Abuse Prevention

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ClinicalTrials.gov Identifier: NCT02622451
Recruitment Status : Recruiting
First Posted : December 4, 2015
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Natalis Counseling Center
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Adolescent Substance Use Behavioral: Teen Intervene Behavioral: Everyday Parenting Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Differential Sensitivity Markers in Youth Drug Abuse Prevention
Study Start Date : December 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Parenting

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622451


Contacts
Contact: Gerald August, Ph.D. augus001@umn.edu
Contact: Nicole Morrell, M.Ed. 612-624-2600 morre006@umn.edu

Locations
United States, Minnesota
Center for Personalized Prevention Research in Children's Mental Health Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Nicole Morrell, M.Ed.    612-624-2600    morre006@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
Natalis Counseling Center
Investigators
Principal Investigator: Gerald August, Ph.D. University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02622451     History of Changes
Other Study ID Numbers: R34DA037888 ( U.S. NIH Grant/Contract )
R34DA037888 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders