NCT02622451

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

4.3 years

First QC Date

December 2, 2015

Last Update Submit

September 18, 2020

Conditions

Adolescent Substance Use

Outcome Measures

Primary Outcomes (16)

  • 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

Study Arms (2)

Youth Behavioral Intervention

OTHER

Teen Intervene

Behavioral: Teen Intervene

Parent Education

OTHER

Everyday Parenting

Behavioral: Everyday Parenting

Interventions

Teen InterveneBEHAVIORAL

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.

Youth Behavioral Intervention
Everyday ParentingBEHAVIORAL

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.

Parent Education

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Personalized Prevention Research in Children's Mental Health

Minneapolis, Minnesota, 55415, United States

Location

Study Officials

  • Gerald August, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 4, 2015

Study Start

December 1, 2015

Primary Completion

March 8, 2020

Study Completion

March 8, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)