Substance Use DisordersNCT04281719
M-Health for Teen Substance Abuse and Mental Illness Pilot
A study testing Mobile Application (working name: Bright Path) in people with Substance Use Disorders and Post Traumatic Stress Disorder, run by Indiana University.
Trial summary
The study is exploring the ease and ability to integrate a mobile application in outpatient behavioral health treatment. There are two major aims to the study: 1) Determine feasibility and acceptability of integrating a mobile app into behavioral health treatment for adolescents with co-occurring substance use and… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Post Traumatic Stress Disorder, Adolescent Behavior
- What is being tested?
- Mobile Application (working name: Bright Path)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Aug 2021
- 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 14-17 years
- Current substance use disorder (SUD)
- Co-occurring mental health disorder
- Treatment-seeking
- English-speaking (Only English documents will be used throughout the course of this research study)
- Clinician delivering outpatient dual diagnosis treatment (i.e., for co-occurring SUDs and mental health disorders)
- Therapist with at least a Master's degree in a counseling related field
Who cannot join
- Younger than 14 or older than 17
- Endorsement of active suicidal or homicidal ideation
- Active mania or psychosis
- Significant cognitive disability, developmental delays, or pervasive developmental disability
- No history of outpatient psychotherapy.
About this study
Official title: M-Health for Teen Substance Abuse and Mental Illness: Component III
The study is exploring the ease and ability to integrate a mobile application in outpatient behavioral health treatment. There are two major aims to the study: 1) Determine feasibility and acceptability of integrating a mobile app into behavioral health treatment for adolescents with co-occurring substance use and mental health disorders, and 2) identify initial signal of effect on engagement and/or treatment outcomes among youth who use the mobile app.
Read the detailed description
The purpose of the trial will be to demonstrate the feasibility of the proposed methodology (rate of recruitment, retention at 4-month follow-up, study procedures) as well as estimates of effect on key variables (patient engagement, patient symptoms, use of e-tools, treatment efficiency) in preparation for future studies in this line evaluating the utility of the mobile app.
- Conditions
- Substance Use Disorders, Post Traumatic Stress Disorder, Adolescent Behavior, Mental Health Disorder
- Being tested
- Mobile Application (working name: Bright Path)
- Medical subject headings
- Substance-Related Disorders, Stress Disorders, Post-Traumatic, Adolescent Behavior, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application (working name: Bright Path)Other
The Bright Path web-based mobile application is designed to target co-occurring problems, enhance patient treatment engagement, and contribute to lasting improvements in teens' mental health. The central hypothesis is that developmentally tailored mobile applications that incorporate evidence-based treatment principles can facilitate increased patient engagement in and between sessions, thus, improving the efficiency, efficacy, and reach of treatments for this highly vulnerable population.
| Study group | Role | What they receive |
|---|---|---|
| Mobile App | Experimental | Youth will be assigned to interact with a novel mobile application during a course of outpatient psychotherapy for substance use disorder(s) and co-occurring mental health disorder(s). Receives: Other: Mobile Application (working name: Bright Path) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients retained in study protocol
Retention of >75% of adolescents through assessments measured by study participant enrollment records. The retention rate will be measured by the number of sessions attended.
Measured: 4 months post-baseline
Provider satisfaction assessed by Treatment Evaluation Inventory-Short Form (TEI-SF)
Providers express high satisfaction with e-tools per published norms on the TEI-SF. The Treatment Evaluation Inventory Short Form (TEI-SF) is a 9-item questionnaire that is rated on a 5-point scale. Scores range from 9 to 45 for each treatment with higher scores indicating greater acceptability of the model.
Measured: 4 months post-baseline
Adolescent satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)
Adolescents express high satisfaction with e-tools per published norms. The Client Satisfaction Questionnaire-8, an 8 question survey with ratings from 1 to 4 is used. Scores can range from 8 to 32 with higher scores indicating greater satisfaction.
Measured: 4 months post-baseline
Patient Engagement assessed by the Child Improvement Rating Scale (CIRS)
Provider-rated youth engagement in treatment process.This will be assessed by the Child Involvement Rating Scale (CIRS) which is a 6 item questionnaire with each item being rated on a 6 item scale ranging from 0 to 5. The questionnaire contains 4 items assessing positive involvement and 2 items assessing negative involvement. The positive items are scored according to the selected scale value while the negative involvement items are reverse scored. Higher scores correspond to greater perceived patient involvement.
Measured: 4 months post-baseline
Secondary outcomes (4)
Substance Use Disorder (SUD) Symptoms measured by CRAFFT
Providers record a decrease in SUD symptoms for patients participating in the study and treatment. The CRAFFT, a 6-item questionnaire in which every "yes" scores 1 point is used to measure substance abuse and dependence. A score of 2 or higher indicates a positive screening.
Measured: 4 months post-baseline
Substance Use Disorder (SUD) Symptoms assessed by the Drug Abuse Screening Test for Adolescents (DAST-20-A)
Providers record a decrease in SUD symptoms for patients participating in the study and treatment. The Drug Abuse Screening Test-20 Adolescent Version (DAST-20-A) is a 20-item self-report questionnaire. Higher scores indicate a greater severity in substance use and can be broken down into the following ranges: 0 (n/a), 1-5 (low), 6-10 (intermediate, likely meets DSM criteria), 11-15 (substantial), 16-20 (severe).
Measured: 4 months post-baseline
Post-Traumatic Stress Disorder (PTSD) Symptoms (If applicable)
Providers record a decrease in PTSD symptoms for patients participating in the study and treatment. The PTSD Symptom Scale for DSM-5 (CPSS-5) is used for evaluation. The CPSS-5 is a 20-item symptom checklist in which symptom severity can be rated from 0 to 4. Higher scores indicate greater symptom severity and can be broken down into the following ranges: 0-10 (minimal), 11-20 (mild), 21-40 (moderate), 41-60 (severe), 61-80 (very severe)
Measured: 4 months post-baseline
Therapeutic alliance as measured by the Therapeutic Alliance Scale for Children-Revised (TASC-R)
Providers record high therapeutic alliance per published norms. The TASC-R includes 12 items rated on a Likert scale from 1 (not true) to 4 (very much true), with item scores summed for a total, where higher scores correspond to higher therapeutic alliance.
Measured: 4 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Why it stopped: Unanticipated technical issues and COVID-19 related-disruptions precluded enrollment of participants before the end of the award period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Information Technology Solutions (HITS) LLC
- Responsible party
- Principal investigator, Zachary W. Adams, Indiana University
- Investigators
- Zachary W Adams, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281719
- Sponsor's protocol ID
- 1908720822
- Status last verified
- Mar 2022
- First submitted
- 31 Jan 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M-Health for Teen Substance Abuse and Mental Illness: Component III
- ClinicalTrials.gov ID
- NCT04281719
- Acronym / sponsor ID
- 1908720822
- Conditions
- Substance Use Disorders, Post Traumatic Stress Disorder, Adolescent Behavior, Mental Health Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unanticipated technical issues and COVID-19 related-disruptions precluded enrollment of participants before the end of the award period.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Health Information Technology Solutions (HITS) LLC
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 24 Feb 2020 (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.
The study is exploring the ease and ability to integrate a mobile application in outpatient behavioral health treatment. There are two major aims to the study: 1) Determine feasibility and acceptability of integrating a mobile app into behavioral health treatment for adolescents with co-occurring substance use and mental health disorders, and 2) identify initial signal of effect on engagement and/or treatment outcomes among youth who use the mobile app.
Detailed description
The purpose of the trial will be to demonstrate the feasibility of the proposed methodology (rate of recruitment, retention at 4-month follow-up, study procedures) as well as estimates of effect on key variables (patient engagement, patient symptoms, use of e-tools, treatment efficiency) in preparation for future studies in this line evaluating the utility of the mobile app.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile App | Experimental | Other: Mobile Application (working name: Bright Path)Youth will be assigned to interact with a novel mobile application during a course of outpatient psychotherapy for substance use disorder(s) and co-occurring mental health disorder(s). |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 14-17 years
- Current substance use disorder (SUD)
- Co-occurring mental health disorder
- Treatment-seeking
- English-speaking (Only English documents will be used throughout the course of this research study)
Key exclusion criteria (5 listed)
- Younger than 14 or older than 17
- Endorsement of active suicidal or homicidal ideation
- Active mania or psychosis
- Significant cognitive disability, developmental delays, or pervasive developmental disability
- No history of outpatient psychotherapy.
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 |
|---|---|---|
| Mobile Application (working name: Bright Path)The Bright Path web-based mobile application is designed to target co-occurring problems, enhance patient treatment engagement, and contribute to lasting improvements in teens' mental health. The central hypothesis is that developmentally tailored mobile applications that incorporate evidence-based treatment principles can facilitate increased patient engagement in and between sessions, thus, improving the efficiency, efficacy, and reach of treatments for this highly vulnerable population. | Other | Mobile App |
Primary outcome
Percent of patients retained in study protocol
Time frame: 4 months post-baseline
Retention of >75% of adolescents through assessments measured by study participant enrollment records. The retention rate will be measured by the number of sessions attended.
Provider satisfaction assessed by Treatment Evaluation Inventory-Short Form (TEI-SF)
Time frame: 4 months post-baseline
Providers express high satisfaction with e-tools per published norms on the TEI-SF. The Treatment Evaluation Inventory Short Form (TEI-SF) is a 9-item questionnaire that is rated on a 5-point scale. Scores range from 9 to 45 for each treatment with higher scores indicating greater acceptability of the model.
Adolescent satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)
Time frame: 4 months post-baseline
Adolescents express high satisfaction with e-tools per published norms. The Client Satisfaction Questionnaire-8, an 8 question survey with ratings from 1 to 4 is used. Scores can range from 8 to 32 with higher scores indicating greater satisfaction.
Patient Engagement assessed by the Child Improvement Rating Scale (CIRS)
Time frame: 4 months post-baseline
Provider-rated youth engagement in treatment process.This will be assessed by the Child Involvement Rating Scale (CIRS) which is a 6 item questionnaire with each item being rated on a 6 item scale ranging from 0 to 5. The questionnaire contains 4 items assessing positive involvement and 2 items assessing negative involvement. The positive items are scored according to the selected scale value while the negative involvement items are reverse scored. Higher scores correspond to greater perceived patient involvement.
4 secondary outcomes
Substance Use Disorder (SUD) Symptoms measured by CRAFFT
Time frame: 4 months post-baseline
Substance Use Disorder (SUD) Symptoms assessed by the Drug Abuse Screening Test for Adolescents (DAST-20-A)
Time frame: 4 months post-baseline
Post-Traumatic Stress Disorder (PTSD) Symptoms (If applicable)
Time frame: 4 months post-baseline
Therapeutic alliance as measured by the Therapeutic Alliance Scale for Children-Revised (TASC-R)
Time frame: 4 months post-baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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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.
Zachary W Adams, PhD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application (working name: Bright Path) in people with Substance Use Disorders and Post Traumatic Stress Disorder, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Percent of patients retained in study protocol (time frame: 4 months post-baseline). The study lists 4 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 6 Apr 2022.