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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Depression, Anxiety; Depression in Adolescence
• Intervention / Treatment: Other: CBToolkit

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • 3C Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CBToolkit; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usage Metrics from the CBToolkit system for adolescents	The CBToolkit software will tracks progress through the modules, and the length of time spent on each sections of the module. These metrics are measured in seconds. A longer time generally indicates more time spent with the content.	The period in which adolescents interact with the system, approximately 2 weeks
Feedback interviews with adolescents	Adolescents will participate in individual interviews. They will be asked about their experience with the CBToolkit, strengths and weaknesses of CBToolkit, and challenges to using CBToolkit.. Comments will be combined and grouped based on themes in a qualitative summary.	15-minutes, completed after the test of the CBToolkit system

Collaborators and Investigators

• Sponsor: 3-C Institute for Social Development
• Collaborators: University of Miami; Stony Brook University
• Investigators: Principal Investigator: Melissa DeRosier, PhD, 3C Institute; Principal Investigator: Jill Ehrenreich-May, PhD, University of Miami; Principal Investigator: Jessica Schleider, PhD, StoneyBrook University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 3CG078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No