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Differential Sensitivity Markers in Youth Drug Abuse Prevention

Primary Purpose

Adolescent Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teen Intervene
Everyday Parenting
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Substance Use

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Personalized Prevention Research in Children's Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Youth Behavioral Intervention

Parent Education

Arm Description

Teen Intervene

Everyday Parenting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 2, 2015
Last Updated
September 18, 2020
Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA), Natalis Counseling Center
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1. Study Identification

Unique Protocol Identification Number
NCT02622451
Brief Title
Differential Sensitivity Markers in Youth Drug Abuse Prevention
Official Title
Differential Sensitivity Markers in Youth Drug Abuse Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
March 8, 2020 (Actual)
Study Completion Date
March 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Drug Abuse (NIDA), Natalis Counseling Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Substance Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald August, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Personalized Prevention Research in Children's Mental Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Differential Sensitivity Markers in Youth Drug Abuse Prevention

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