Developing the Unified Protocol-Single Session Experience Platform for Adolescent Mental Health
Condition: Depression; Depression, Anxiety; Depression in Adolescence; Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): CBToolkit
Intervention type(s): Other
Intervention description(s): 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 model: Single Group Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment