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

NCT ID: NCT06213142

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-08-31

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.

Conditions

Depression; Depression, Anxiety; Depression in Adolescence; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CBToolkit

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: collaborator

3-C Institute for Social Development

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa DeRosier, PhD

Role: PRINCIPAL_INVESTIGATOR

3C Institute

Jill Ehrenreich-May, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Jessica Schleider, PhD

Role: PRINCIPAL_INVESTIGATOR

StoneyBrook University

Locations

3C Institute

Durham, North Carolina, United States

Countries

United States

Other Identifiers

3CG078

Identifier Type: -

Identifier Source: org_study_id