Developing the Unified Protocol-Single Session Experience Platform for Adolescent Mental Health

NCT06213142 | Completed

• 1 other identifier: 3CG078
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depression, Anxiety; Depression in Adolescence; Anxiety

Outcome Measures

Primary Outcomes (3)

• Program Feedback Scale for Adolescents

  Adolescents will complete this 12-item measure, rating the extent to which they agree with statements about the usability, acceptability, and feasibility of the CBToolkit modules. The measure includes 9 Likert items and 3 open-ended items. Responses to the Likert items range from 1 (Really Disagree) to 5 (Really Agree). Total scores are based on the Likert items are range from 0 to 45. Higher scores reflect more positive opinions.

  2 week followup post module review

• Module Knowledge

  Adolescents will complete this 9-item measure to determine what they know about key concepts taught in the CBToolkit module prior to and following review of the modules. The measure includes 9 multiple choice items with a 1 correct response per item. Total scores are based on the number of items with correct responses and range from 0 to 9. Higher scores reflect more correct responses.

  Average of 2 weeks apart, as pre- and post-tests

• Revised Children's Anxiety and Depression Scale- Shortened

  Adolescents will complete the shortened 11-item version of this measure to assess levels of anxiety and depression prior to and following review of the modules. The measure includes 11 Likert items. Responses to the Likert items range from 0- Never to 3- Always. Total scores are based on the Likert items are range from 0 to 33. Higher scores reflect more severe symptoms.

  Average of 2 weeks apart, as pre- and post-tests

Secondary Outcomes (2)

• Usage Metrics from the CBToolkit system for adolescents

  The period in which adolescents interact with the system, approximately 2 weeks

• Feedback interviews with adolescents

  15-minutes, completed after the test of the CBToolkit system

Study Arms (1)

CBToolkit

EXPERIMENTAL

CBToolkit includes two SSI modules: (1) Mindful Awareness, with the goal of increasing awareness and tolerance of physical sensations and emotional experiences using mindfulness practices and tips and (2) Flexible Problem Solving, with the goal of promoting cognitive flexibility, applying problem-solving strategies in difficult scenarios, and learning to modify behavioral action tendencies.

Other: CBToolkit

Interventions

CBToolkit OTHER

CB Toolkit Mindful Awareness module to increase awareness and tolerance of physical sensations and emotional experiences using mindfulness practices. The module involves videos with motion graphics, video demos, voiceover, music, and sound effects intermixed throughout with a variety of interactive exercises tailored to specific core components. The module aims to establish understanding of the intervention concept (psychoeducation), increase self-efficacy in mindfulness skills via active practice and personalized feedback, and facilitate self-reflection and understanding of strengths and improvement areas related to mindfulness. CBToolkit Flexible Problem Solving module to promote cognitive flexibility, applying problem-solving strategies in difficult scenarios, and learning to modify behavioral action tendencies. Videos and activities will be tailored to provide examples of effective problem-solving techniques and provide personalized reinforcing and/or scaffolded feedback.

CBToolkit

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• 3-C Institute for Social Development: lead
• University of Miami: collaborator
• Stony Brook University: collaborator

Study Sites (1)

3C Institute

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Melissa DeRosier, PhD

  3C Institute

  PRINCIPAL INVESTIGATOR

• Jill Ehrenreich-May, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Jessica Schleider, PhD

  StoneyBrook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 19, 2024
• Study Start: June 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)