Differential Sensitivity Markers in Youth Drug Abuse Prevention

Adolescent Substance Use Clinical Trial

Official title:

Differential Sensitivity Markers in Youth Drug Abuse Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622451
• Other study ID #: 1504S69041
• Secondary ID: R34DA037888
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: March 8, 2020

Study information

• Verified date: September 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 8, 2020
• Est. primary completion date: March 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Substance Use
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for Personalized Prevention Research in Children's Mental Health	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	Natalis Counseling Center, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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