Clinical trial NCT02622451: Differential Sensitivity Markers in Youth Drug Abuse Prevention
Official title: Differential Sensitivity Markers in Youth Drug Abuse Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Substance Use
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Natalis Counseling Center
First posted: 2015-12-04
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Delayed Discounting Task
timeFrame: 4 months post-intervention
measure: Iowa Gambling Task
timeFrame: 4 months post-intervention
measure: Urinalysis
timeFrame: 4 months post-intervention
measure: Peer Substance Use Test
timeFrame: 4 months post-intervention
measure: Peer Delinquency Scale
timeFrame: 4 months post-intervention
measure: Project Towards No Drug Abuse Survey
timeFrame: 4 months post-intervention
measure: Alcohol Expectancy Questionnaire
timeFrame: 4 months post-intervention
measure: Single-item self-efficacy Scale
timeFrame: 4 months post-intervention
measure: Client Satisfaction Questionnaire
timeFrame: 4 months post-intervention
measure: Highly Sensitive Person Scale
timeFrame: 4 months post-intervention
measure: Parental Monitoring Instrument
timeFrame: 4 months post-intervention
measure: Parenting Relationship Questionnaire (PRQ)
timeFrame: 4 months post-intervention
measure: Family Problem Solving Communication Index
timeFrame: 4 months post-intervention
measure: Parental Locus of Control Questionnaire
timeFrame: 4 months post-intervention
measure: Family Assessment Measure - III
timeFrame: 4 months post-intervention
measure: Conflict Behavior Questionnaire
timeFrame: 4 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Center for Personalized Prevention Research in Children's Mental Health
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Gerald August, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: