M-Health for Teen Substance Abuse and Mental Illness Pilot

Post Traumatic Stress Disorder Clinical Trial

Official title:

M-Health for Teen Substance Abuse and Mental Illness: Component III

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04281719
• Other study ID #: 1908720822
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 mental health disorders, and 2) identify initial signal of effect on engagement and/or treatment outcomes among youth who use the mobile app.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

Inclusion Criteria for Adolescents:

• 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)

Exclusion Criteria for Adolescents:

• 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. Inclusion Criteria for Providers
• 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

Related Conditions & MeSH terms

• Adolescent Behavior
• Disease
• Mental Disorders
• Mental Health Disorder
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Health Information Technology Solutions (HITS) LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months post-baseline
Primary	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.	4 months post-baseline
Primary	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.	4 months post-baseline
Primary	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.	4 months post-baseline
Secondary	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.	4 months post-baseline
Secondary	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).	4 months post-baseline
Secondary	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)	4 months post-baseline
Secondary	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.	4 months post-baseline