Substance UseASPIRENCT06306287
Adolescent Screening and Personalized Intervention Resource for Enhancement of Behavioral Health and Substance Use
A study testing ePACE Personalized Intervention and eFACE Fixed Intervention in people with Substance Use and Mental Health Issue, run by Oregon Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Mental Health Issue
- What is being tested?
- ePACE Personalized Intervention and eFACE Fixed Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Adolescent Inclusion Criteria:
- 12-17 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
Adolescent Exclusion Criteria:
- 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
Parent Inclusion Criteria:
- sufficient English language skills for assessments and intervention
Parent Exclusion Criteria:
- another parent or parent figure is already participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Institute
Albuquerque, New Mexico, 87109
About this study
Official title: Adolescent Screening and Personalized Intervention Resource for Mild/Moderate Substance Use and Co-Occurring Problems
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.
Read the detailed description
This clinical trial is designed to test a technology-based, multicomponent behavioral health intervention for adolescents who have begun to experience behavioral health problems, including substance use. The design and functionality of the mobile health intervention, called eHealth Personalized Approach for Change Efficacy (ePACE), is grounded in two pivotal developmental frameworks. First, the intervention will address the well-established bidirectional relationship between substance use and co-occurring problems in adolescence. Second, in keeping with contemporary patient- and youth-centered health care delivery models, the mobile health intervention will have an interactive design permitting youth to receive feedback and make active choices about the care they receive. These conceptually informed design features and functionalities will optimize youth engagement, empowerment, and agency in order to maximize clinical outcomes. A digital health resource scalable to any smart phone would avert the need for delivery by highly trained professionals, and could be easily accessed by youth, especially those in rural or other settings where resources remain scarce. The ePACE intervention is user-friendly personalized, youth-centered, mobile health resource designed for use as a stand-alone intervention by providers of youth services or integrated into existing programming such as juvenile justice diversion programs, school-based counseling programs, or community behavioral health or drug treatment programs. ePACE is composed of a multi-problem screener to guide the implementation of a set of key integrated behavior change modules (Drug Use, Interpersonal Relations, Negative Emotions, Stress) providing a cohesive focus on substance use and co-occurring problem behaviors. The specific aims of are to:
- Evaluate the impact of ePACE and a "fixed" non-personalized intervention, eHealth Fixed Approach for Change Efficacy (eFACE), for youth with co-occurring problems, relative to a waiting list comparison (WC) group on substance use and related problem outcomes. We expect better outcomes for both ePACE and eFACE vs WC over the 6-month follow-up and expect that ePACE vs WC
- effects will be larger than eFACE vs WC effects.
- Evaluate the direct effects of ePACE and eFACE on targeted areas of functioning and skill development hypothesized to produce change in substance use and co-occurring problems. Youth assigned to ePACE and eFACE are expected to exhibit greater improvements compared to those assigned to WC, with the effects of ePACE larger than those of eFACE.
- Examine factors associated with successful implementation of ePACE, including participant ratings of usability, acceptability, and satisfaction.
The proposed brief, personalized, youth-centered, early intervention approach, web and smart-phone friendly, offers a promising solution for youth service providers to address the underserved needs of youth, potentially mitigating the need for more intensive, costly interventions later and potentially accommodating a youth-serving system that often lacks accessible and affordable behavior health services.
Youth will be recruited to participate in the trial through community organizations such as juvenile justice, schools, and organizations serving parents and adolescents. Participating youth will be randomly assigned to one of three groups (N=40 per group): ePACE, eFACE or WC. Both ePACE and eFACE address substance use and co-occurring problems. However, ePACE is a personalized, youth-centered approach that allows youth a choice of modules they receive, ranging from two to four, the order in which modules are selected, and the feedback they receive from interactive components of the program, depending on youth responses to activities and exercises, whereas ePACE involves a "fixed", non-tailored set of modules that all youth in this condition receive in the same set order with no tailored feedback based on their responses to activities and exercises. The trial design will allow us to examine if ePACE and eFACE outcomes are both superior to WC but ePACE is NOT superior eFACE. Such a finding would suggest that the less complex, fixed, four-module version of the intervention is adequate for scaling and broad implementation efforts. eFACE is arguably lower cost to develop and easier to scale and maintain than ePACE. Thus, finding such support for eFACE (versus WC) could have important implications for dissemination of the program.
- Conditions
- Substance Use, Mental Health Issue
- Being tested
- ePACE Personalized Intervention, eFACE Fixed Intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePACE Personalized InterventionBehavioural
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.
eFACE Fixed InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (6)
Problem-Solving Inventory from baseline to 3-months
Change in youth self-report on 5 subscales of self-confidence in problem solving and decision making from baseline to 3-months.
skills.
Measured: 3 months
Problem-Solving Inventory from baseline to 6-months
Change in youth self-report on 5 subscales of self-confidence in problem solving and decision making from baseline to 6-months.
skills.
Measured: 6 months
Child Global Assessment Scale (CGAS) from baseline to 3-months
Change in the parent rating of the severity of their adolescent's functional impairment from baseline to 3-months. The C-GAS ranges from 1-100 and includes behavioral examples as anchor points.
The C-GAS ranges from 1-100 and includes behavioral examples as anchor points.
Measured: 3 months
Child Global Assessment Scale (CGAS) from baseline to 6-months
Change in the parent rating of the severity of their adolescent's functional impairment from baseline to 6-months. The C-GAS ranges from 1-100 and includes behavioral examples as anchor points.
The C-GAS ranges from 1-100 and includes behavioral examples as anchor points.
Measured: 6 months
Peer Encouragement and Influence from baseline to 3 months
Adolescent perceptions of the extent to which peer drug use influences their own substance use will be measured using the Peer Encouragement and Influence scale. This scale consists of 24 items and ranges from 0 to 108, with higher scores indicating greater negative influence. Change in peer influence will be measured from baseline to the 3-month assessment.
Measured: 3 months
Peer Encouragement and Influence from baseline to 6 months
Adolescent perceptions of the extent to which peer drug use influences their own substance use will be measured using the Peer Encouragement and Influence scale. This scale consists of 24 items and ranges from 0 to 108, with higher scores indicating greater negative influence. Change in peer influence will be measured from baseline to the 6-month assessment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Feb 2024
- Primary completion21 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Youth (n=120) will be randomly assigned to one of three conditions (40 youths per condition): ePACE, eFACE, or waitlist comparison (WC) condition.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306287
- Sponsor's protocol ID
- DA053660
- Acronym
- ASPIRE
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified participant data will be available through the National Institute on Drug Abuse Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Screening and Personalized Intervention Resource for Mild/Moderate Substance Use and Co-Occurring Problems
- ClinicalTrials.gov ID
- NCT06306287
- Acronym / sponsor ID
- ASPIRE / DA053660
- Conditions
- Substance Use, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial is designed to test a technology-based, multicomponent behavioral health intervention for adolescents who have begun to experience behavioral health problems, including substance use. The design and functionality of the mobile health intervention, called eHealth Personalized Approach for Change Efficacy (ePACE), is grounded in two pivotal developmental frameworks. First, the intervention will address the well-established bidirectional relationship between substance use and co-occurring problems in adolescence. Second, in keeping with contemporary patient- and youth-centered health care delivery models, the mobile health intervention will have an interactive design permitting youth to receive feedback and make active choices about the care they receive. These conceptually informed design features and functionalities will optimize youth engagement, empowerment, and agency in order to maximize clinical outcomes. A digital health resource scalable to any smart phone would avert the need for delivery by highly trained professionals, and could be easily accessed by youth, especially those in rural or other settings where resources remain scarce. The ePACE intervention is user-friendly personalized, youth-centered, mobile health resource designed for use as a stand-alone intervention by providers of youth services or integrated into existing programming such as juvenile justice diversion programs, school-based counseling programs, or community behavioral health or drug treatment programs. ePACE is composed of a multi-problem screener to guide the implementation of a set of key integrated behavior change modules (Drug Use, Interpersonal Relations, Negative Emotions, Stress) providing a cohesive focus on substance use and co-occurring problem behaviors. The specific aims of are to:
- Evaluate the impact of ePACE and a "fixed" non-personalized intervention, eHealth Fixed Approach for Change Efficacy (eFACE), for youth with co-occurring problems, relative to a waiting list comparison (WC) group on substance use and related problem outcomes. We expect better outcomes for both ePACE and eFACE vs WC over the 6-month follow-up and expect that ePACE vs WC
- effects will be larger than eFACE vs WC effects.
- Evaluate the direct effects of ePACE and eFACE on targeted areas of functioning and skill development hypothesized to produce change in substance use and co-occurring problems. Youth assigned to ePACE and eFACE are expected to exhibit greater improvements compared to those assigned to WC, with the effects of ePACE larger than those of eFACE.
- Examine factors associated with successful implementation of ePACE, including participant ratings of usability, acceptability, and satisfaction.
The proposed brief, personalized, youth-centered, early intervention approach, web and smart-phone friendly, offers a promising solution for youth service providers to address the underserved needs of youth, potentially mitigating the need for more intensive, costly interventions later and potentially accommodating a youth-serving system that often lacks accessible and affordable behavior health services.
Youth will be recruited to participate in the trial through community organizations such as juvenile justice, schools, and organizations serving parents and adolescents. Participating youth will be randomly assigned to one of three groups (N=40 per group): ePACE, eFACE or WC. Both ePACE and eFACE address substance use and co-occurring problems. However, ePACE is a personalized, youth-centered approach that allows youth a choice of modules they receive, ranging from two to four, the order in which modules are selected, and the feedback they receive from interactive components of the program, depending on youth responses to activities and exercises, whereas ePACE involves a "fixed", non-tailored set of modules that all youth in this condition receive in the same set order with no tailored feedback based on their responses to activities and exercises. The trial design will allow us to examine if ePACE and eFACE outcomes are both superior to WC but ePACE is NOT superior eFACE. Such a finding would suggest that the less complex, fixed, four-module version of the intervention is adequate for scaling and broad implementation efforts. eFACE is arguably lower cost to develop and easier to scale and maintain than ePACE. Thus, finding such support for eFACE (versus WC) could have important implications for dissemination of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Youth (n=120) will be randomly assigned to one of three conditions (40 youths per condition): ePACE, eFACE, or waitlist comparison (WC) condition.
| Arm | Type | Receives |
|---|---|---|
| ePACE Experimental Condition | Experimental | Behavioral: ePACE Personalized InterventionThe 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. |
| eFACE Active Comparator Condition | Active comparator | Behavioral: eFACE Fixed InterventionThe 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. |
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePACE Personalized InterventionThe 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. | Behavioural | ePACE Experimental Condition |
| eFACE Fixed InterventionThe 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. | Behavioural | eFACE Active Comparator Condition |
Primary outcome
Adolescent Substance Use from baseline to 3 months
Time frame: 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.
Adolescent Substance Use from baseline to 6 months
Time frame: 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.
Youth Report of Internalizing Problems from baseline to 3 months
Time frame: 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.
Youth Report of Internalizing Problems Change from baseline to 6-months
Time frame: 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.
Youth Report of Externalizing Problems from baseline to 3-months
Time frame: 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.
Youth Report of Externalizing Problems from baseline to 6-months
Time frame: 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.
Parent Report of Internalizing Problems from baseline to 3-months
Time frame: 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.
Parent Report Internalizing Problems from baseline to 6-months
Time frame: 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.
Parent Report Externalizing Problems from baseline to 3-months
Time frame: 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.
Parent Report Externalizing Problems from baseline to 6-months
Time frame: 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 secondary outcomes
Problem-Solving Inventory from baseline to 3-months
Time frame: 3 months
Problem-Solving Inventory from baseline to 6-months
Time frame: 6 months
Child Global Assessment Scale (CGAS) from baseline to 3-months
Time frame: 3 months
Child Global Assessment Scale (CGAS) from baseline to 6-months
Time frame: 6 months
Peer Encouragement and Influence from baseline to 3 months
Time frame: 3 months
Peer Encouragement and Influence from baseline to 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. All de-identified participant data will be available through the National Institute on Drug Abuse Data Archive.
Related trials for Substance Use
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePACE Personalized Intervention and eFACE Fixed Intervention in people with Substance Use and Mental Health Issue, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Substance Use from baseline to 3 months (time frame: 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.