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

NCT06306287 | Recruiting

• 1 other identifier: DA053660
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (10)

• Adolescent Substance Use from baseline to 3 months

  Using a Timeline Followback approach, the total number of days on which any substances were used (excluding tobacco and appropriately used prescription medications) will be identified and the percentage of these days in the prior 90 days will be calculated for each assessment point. The change in substance use from baseline to 3-months will serve as a primary outcome measure.

  3 months

• Adolescent Substance Use from baseline to 6 months

  Using a Timeline Followback approach, the total number of days on which any substances were used (excluding tobacco and appropriately used prescription medications) will be identified and the percentage of these days in the prior 90 days will be calculated for each assessment point. The change in substance use from baseline to 6-months will also serve as a primary outcome measure.

  6 months

• Youth Report of Internalizing Problems from baseline to 3 months

  The Global Appraisal of Individual Needs - Short Screener Internalizing subscale will be used to measure youth internalizing problems. The subscale consists of 6 items, with scores ranging from 0 to 24 and higher scores indicating greater problem severity. The outcome measure is the change in internalizing scores from baseline to the 3-month. assessment.

  3 months

• Youth Report of Internalizing Problems Change from baseline to 6-months

  The Global Appraisal of Individual Needs - Short Screener Internalizing subscale will be used to measure youth internalizing problems. The subscale consists of 6 items, with scores ranging from 0 to 24 and higher scores indicating greater problem severity. The outcome measure is the change in internalizing scores from baseline to the 6-month assessment.

  6 months

• Youth Report of Externalizing Problems from baseline to 3-months

  The Global Appraisal of Individual Needs - Short Screener (GSS) Externalizing subscale will be used to measure youth externalizing problems. The subscale consists of 7 items, with scores ranging from 0 to 28 and higher scores indicating greater problem severity. The outcome measure is the change in externalizing scores from baseline to the 3-month assessment.

  3 months

• Youth Report of Externalizing Problems from baseline to 6-months

  The Global Appraisal of Individual Needs - Short Screener (GSS) Externalizing subscale will be used to measure youth externalizing problems. The subscale consists of 7 items, with scores ranging from 0 to 28 and higher scores indicating greater problem severity. The outcome measure is the change in externalizing scores from baseline to the 6-month assessment.

  6 months

• Parent Report of Internalizing Problems from baseline to 3-months

  The Internalizing subscale score on the Brief Problem Monitor (short version of the Child Behavior Checklist) will be used to measure parent report of internalizing problems. The Brief Problem Monitor Internalizing subscale consists of 6 items and ranges from 1 to 12, with higher scores indicating greater problem severity. The outcome measure is the change in internalizing scores from baseline to the 3-month assessment.

  3 months

• Parent Report Internalizing Problems from baseline to 6-months

  The Internalizing subscale score on the Brief Problem Monitor (short version of the Child Behavior Checklist) will be used to measure parent report of internalizing problems. The Brief Problem Monitor Internalizing subscale consists of 6 items and ranges from 1 to 12, with higher scores indicating greater problem severity. The outcome measure is the change in internalizing scores from baseline to the 6-month assessment.

  6 months

• Parent Report Externalizing Problems from baseline to 3-months

  The Externalizing subscale score on the Brief Problem Monitor (short version of the Child Behavior Checklist) will be used to measure parent report of externalizing problems. The Brief Problem Monitor Externalizing subscale consists of 7 items and ranges from 1 to 14, with higher scores indicating greater problem severity. The outcome measure is the change in externalizing scores from baseline to the 3-month assessment.

  3 months

• Parent Report Externalizing Problems from baseline to 6-months

  The Externalizing subscale score on the Brief Problem Monitor (short version of the Child Behavior Checklist) will be used to measure parent report of externalizing problems. The Brief Problem Monitor Externalizing subscale consists of 7 items and ranges from 1 to 14, with higher scores indicating greater problem severity. The outcome measure is the change in externalizing scores from baseline to the 6-month assessment.

  6 months

Secondary Outcomes (6)

• Problem-Solving Inventory from baseline to 3-months

  3 months

• Problem-Solving Inventory from baseline to 6-months

  6 months

• Child Global Assessment Scale (CGAS) from baseline to 3-months

  3 months

• Child Global Assessment Scale (CGAS) from baseline to 6-months

  6 months

• Peer Encouragement and Influence from baseline to 3 months

  3 months

Other Outcomes (4)

• Emotion Regulation from baseline to 3 months

  3 months

• Emotion Regulation - baseline to 6 months

  6 months

• Change in Urine assay - baseline to 3 months

  3 months

Study Arms (3)

ePACE Experimental Condition

EXPERIMENTAL

The experimental intervention to be administered, ePACE, is a web-based brief intervention that includes personalization and youth-centered features. Feedback is provided based on youth's responses to activities, exercises, and quizzes to guide each individual's behavior change efforts.

Behavioral: ePACE Personalized Intervention

eFACE Active Comparator Condition

ACTIVE COMPARATOR

The eFACE active comparator arm involves the eFACE intervention and includes content that is similar to the ePACE experimental intervention, but modules are offered in a fixed order with no tailoring features. No personalized feedback based on youth responses are provided to inform individual youth's behavior change efforts.

Behavioral: eFACE Fixed Intervention

Waiting List Comparison Group

NO INTERVENTION

Youth in the waitlist comparison (WC) condition will not have access to the ePACE or eFACE modules until the final (6-month) assessment has been completed. Thus, the WC group will serve as a "no intervention" comparison group.

Interventions

ePACE Personalized Intervention BEHAVIORAL

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.

ePACE Experimental Condition

eFACE Fixed Intervention BEHAVIORAL

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.

eFACE Active Comparator Condition

Eligibility Criteria

• Age: 12 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• live at home with at least one parent or parent figure
• reporting mild/moderate substance use
• reporting mental health issues
• sufficient English language skills for assessments and intervention

You may not qualify if:

• a sibling has already participated in the study
• evidence of psychotic or organic state
• high problem severity indicating possible need for higher level of care
• sufficient English language skills for assessments and intervention
• another parent or parent figure is already participating in the study

Sponsors & Collaborators

• Oregon Research Institute: lead

Study Sites (1)

Oregon Research Institute

Albuquerque, New Mexico, 87109, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Holly B Waldron, PhD

CONTACT

5419156196; hwaldron@ori.org

Ken C Winters, PhD

CONTACT

6123877691; kwinters@ori.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and the assessors will not have access to the conditions to which participants are assigned until all data are collected.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Youth (n=120) will be randomly assigned to one of three conditions (40 youths per condition): ePACE, eFACE, or waitlist comparison (WC) condition.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 12, 2024
• Study Start: February 15, 2024
• Primary Completion: November 30, 2024
• Study Completion: April 30, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be entered into the data archive annually after recruitment has begun.
• Access Criteria: Compliant with the data archive requirements.

Locations

US (1)