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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06213142
Study type Interventional
Source 3-C Institute for Social Development
Contact
Status Completed
Phase N/A
Start date June 1, 2023
Completion date August 31, 2023

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