Clinical trial NCT06213142: Developing the Unified Protocol-Single Session Experience Platform for Adolescent Mental Health
Official title: Developing the Unified Protocol-Single Session Experience Platform for Adolescent Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depression, Anxiety
Depression in Adolescence
Anxiety
Lead sponsor: 3-C Institute for Social Development
Sponsor class: INDUSTRY
Collaborators: name: University of Miami
name: Stony Brook University
First posted: 2024-01-19
Enrollment: 57
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants in the acceptability test will be assigned to the same set of study tasks, where all participants will engage with the two modules and provide feedback. All participants will complete the RCADS pre and post, in addition to all study-related surveys: demographics, pre- and post-knowledge checks, module component ratings, prototype evaluations, and advocacy ratings. All participants will be invited to the follow-up focus group sessions.
Primary purpose: TREATMENT

Brief summary: This SBIR Phase I proposal will develop and test the acceptability and feasibility of a new suite of digital Single-Session Interventions, specifically applying Unified Protocol core principles for emotional disorders, to produce a highly accessible, engaging, and scalable product to help address the clinical needs of youth.

Detailed description: This project proposes develop a suite of Single Session Intervention (SSI) modules using the Unified Protocol (UP) core principles. For Phase I, the team will develop two SSI modules from UP: Awareness of Physical Sensations and Emotional Experiences, and Being Flexible in Your Problem Solving. For the acceptability test (Specific Aim 2), investigators will recruit 60 youth who are screened as eligible based on the internalizing subscale of the Pediatric Symptom Checklist. Caregivers/parents of youth will be recruited using targeted social media advertisements, where they can view a brief study description and complete the eligibility screener. If interested, caregivers can provide contact information for the study team to conduct consent and assent processes. Following consent and enrollment, participants will receive private login information to access the prototype and study materials. First, participants will complete pre-surveys that collect demographic information and responses to the Revised Children's Anxiety and Depression Scale (RCADS). Next, participants will take a brief survey to assess knowledge of intervention concepts presented in the first module: Mindful Awareness. Then, they will engage with the module and provide feedback on the quality of its components. Then, they will complete the knowledge assessment again. Participants will complete the same process for the second module: Flexible Problem Solving (pre knowledge check, review, rate the quality, and post knowledge check). Participants will complete a product evaluation to rate their overall experience with the prototype (quality, usability, innovation, feasibility, and value) and the degree they advocate for full product development. Finally, participants will take the RCADS at the end of the review period. There will also be an opportunity for participants to participate in a brief feedback call to provide additional feedback.

Eligibility criteria: Inclusion Criteria:

* be ages 13 to 17 years old
* be willing and available to take part in the study requirements
* be fluent in English
* have access to the internet with a mobile device or personal computer
* have parent permission
* screen as eligible according to the internalizing subscale from the Pediatric Symptom Checklist

Exclusion Criteria:

Primary outcomes:
measure: Program Feedback Scale for Adolescents
timeFrame: 2 week followup post module review
measure: Module Knowledge
timeFrame: Average of 2 weeks apart, as pre- and post-tests
measure: Revised Children's Anxiety and Depression Scale- Shortened
timeFrame: Average of 2 weeks apart, as pre- and post-tests
Secondary outcomes:
measure: Usage Metrics from the CBToolkit system for adolescents
timeFrame: The period in which adolescents interact with the system, approximately 2 weeks
measure: Feedback interviews with adolescents
timeFrame: 15-minutes, completed after the test of the CBToolkit system
Other outcomes:
Locations:
city: Durham
country: United States
facility: 3C Institute
state: North Carolina
Study officials:
affiliation: 3C Institute
name: Melissa DeRosier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Jill Ehrenreich-May, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: StoneyBrook University
name: Jessica Schleider, PhD
role: PRINCIPAL_INVESTIGATOR
References: