Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04281719
Other study ID # 1908720822
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Recruiting NCT05934175 - Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder N/A
Recruiting NCT05934162 - Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD N/A
Completed NCT04460014 - Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT N/A
Completed NCT05877807 - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Active, not recruiting NCT05992649 - The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 40-week Pilotproject N/A
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Not yet recruiting NCT05331534 - Effect of Attentional Therapy on Post-traumatic Stress Disorder N/A
Not yet recruiting NCT04076215 - Biochemical and Physiological Response to Stressogenic Stimuli N/A
Not yet recruiting NCT03649607 - Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black N/A
Not yet recruiting NCT02545192 - A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments Phase 1
Completed NCT02329418 - Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit N/A
Active, not recruiting NCT00978484 - A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder Phase 3
Completed NCT00760734 - Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT03278171 - Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit
Recruiting NCT05874362 - People Bereaved by Violent Death : Negative Event Biases and Temporal Perception N/A
Terminated NCT03898843 - Assisted Animal Therapy: ReAnimal N/A
Recruiting NCT04747379 - Psychological Effect of Explicit Recall After Sedation (PEERS)
Completed NCT03248167 - Cannabidiol as a Treatment for AUD Comorbid With PTSD Phase 1/Phase 2