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

Depression Clinical Trial

— CBToolkit  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06213142
• Other study ID #: 3CG078
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: January 2024
• Source: 3-C Institute for Social Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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:

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depression in Adolescence
• Depression, Anxiety
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	3C Institute	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
3-C Institute for Social Development	Stony Brook University, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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