Adolescent Screening and Personalized Intervention Resource for Enhancement of Behavioral Health and Substance Use

NCT06306287 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-22

No results posted yet for this study

Summary

Only a small fraction of youth who are beginning to experience behavioral health problems and use alcohol or illicit drugs receive needed treatment services due to the lack of accessible, effective early intervention resources. The goal of this clinical trial is to compare a personalized brief web-based early intervention, eHealth Personalized Approach for Change Efficacy (ePACE), in which youth are offered choices regarding intervention content and desired level of engagement, to a "fixed", non-tailored brief intervention, eHealth Fixed Approach for Change Efficacy (eFACE) for adolescents with mild/moderate substance use and common co-occurring problems. Both ePACE and eFACE include a multi-problem screener that guides youths through a set of key integrated behavior change and counseling modules providing a cohesive focus on these four problem domains: drug abuse, interpersonal relations, negative emotions and stress. The main questions the trial aims to answer are:

* Are substance use and co-occurring problem outcomes for ePACE and eFACE are superior to those for a waitlist comparison group (WC)
* Are outcomes for ePACE are superior to those for eFACE
* Are the direct effects of ePACE and eFACE (i.e., the improvements in substance use and co-occurring problem outcomes) associated with improvements in areas of functioning and new skills that are hypothesized to produce change -- that is, are the improvements shown in the ePACE and eFACE groups due to the mechanisms by which change is hypothesized to occur Participants in ePACE and eFACE will complete a baseline assessment prior to engaging in the intervention to which they are assigned and will complete post-intervention assessments 3 months and 6 months later. Participants in the WC group will complete three assessments: at baseline, 3-months, and 6-months.

Conditions

  • Substance Use
  • Mental Health Issue

Interventions

BEHAVIORAL

ePACE Personalized Intervention

The ePACE intervention is based on culturally and developmentally relevant youth treatments organized around an integrative approach based on Motivational Enhancement Therapy (MET) and Cognitive Behavior Therapy (CBT) to enhance motivation for change, support awareness of thoughts, emotions, and behavior, and address specific behavior change goals. The web-based approach is personalized, with youth-driven choices in terms of intensity, content, and sequencing of content and provide tailored feedback to youth regarding each individual's behavior change efforts. Modules address substance use, negative moods, decision-making, and interpersonal relations and require approximately 40-minutes to complete. Interactive activities, exercises, and quizzes are designed to promote skill acquisition. Each module involves an introduction and engagement strategies, several exercises and activities related to the problem area, goal setting, and a summary.

BEHAVIORAL

eFACE Fixed Intervention

The eFACE intervention includes content that is similar to ePACE, but modules are offered in a fixed order with no tailoring features. Like ePACE, modules address substance use, negative moods, decision-making, and interpersonal relations and require approximately 40-minutes to complete. Each module involves an introduction and engagement strategies, several exercises and activities related to the problem area, goal setting, and a summary. However, no personalized feedback based on youth responses are provided to inform individual youth's behavior change efforts.

Sponsors & Collaborators

  • Oregon Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2024-11-30
Completion
2025-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06306287 on ClinicalTrials.gov