Evaluating a Virtual Mentoring Program Plus Mental Health Videos for Teens

NCT06138730 | Active Not Recruiting DMC

• 1 other identifier: STUDY00017822
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluates Appa Health, a mental health smartphone and computer app for teenagers. Appa is built from two components. Component #1 shares short TikTok-style videos with teens to cover techniques from a science-backed mental health treatment, Cognitive Behavioral Therapy. These videos are designed by mental health experts and delivered by mental health influencers. Component #2 pairs teens with peer mentors with similar life experiences, who help guide teens through each week's video content. All peer mentors are trained and supervised by licensed mental health experts. The researchers believe Appa Health improves teens' mental health and well-being through teens' strengthened relationships and support from their mentor, as well as through the skills they gain through watching the videos. This study hopes to understand: (1) whether these Appa Health components improve teens' mental health and well-being, (2) how these components might improve teen outcomes, and (3) costs associated with each of these components. To answer these questions, the researchers will compare two versions of Appa support: Appa Complete and Appa Lite. Appa Complete involves pairing teens with mentors and sharing videos. Appa Lite involves only sharing videos with teens. First, the researchers will conduct a small version of this study to test procedures. Seventy-five teenagers (13-18 years old) with high depression or anxiety scores will be randomly given either: Appa Complete (mentoring + videos), Appa Lite (videos only), or a Waiting List Control. Based on the results of this smaller study, the researchers will change study procedures to improve teens' experiences and engagement in this research. After completing this smaller study, the researchers will run a larger version of the same study with 400 more teens. After teens are randomly given Appa Complete, Appa Lite, or a Waiting List Control, the researchers will test whether Appa's two treatment components improve teens' depression, anxiety, well-being, and other related outcomes. The researchers expect both Appa Complete and Appa Lite will improve teens' outcomes more than the Waiting List Control. The researchers also expect Appa Complete will improve teens' outcomes more than Appa Lite. The researchers will also measure costs associated with giving teens both treatment components and use this information to improve Appa's services for future teens.

Conditions

Depressive Symptoms; Anxiety Disorders and Symptoms

Keywords

Depression; Anxiety; Adolescence; Digital Mental Health; Mentorship

Outcome Measures

Primary Outcomes (3)

• Youth-Reported Psychosocial Functioning

  Youth TOP Problems Scale

  Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

• Youth-Reported Use of CBT

  Skills of Cognitive Therapy Measure (SCT)

  Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

• Youth-Reported Self-Efficacy for CBT

  Self-Efficacy for CBT Scale

  Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

Secondary Outcomes (8)

• Youth-Reported Depressive Symptoms

  Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

• Youth-Reported Anxiety Symptoms

  Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

• Youth-Reported Quality of Life and Flourishing

  Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

• Youth-Reported Self-Esteem

  Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

• Youth-Reported Existential Isolation

  Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

Other Outcomes (13)

• Youth-Reported Youth Demographics

  Baseline (T1)

• Youth-Reported Mentorship Alliance

  6 Weeks Survey (T2) + 12 Weeks Survey (T3) - Appa Complete ONLY

• Youth-Reported Mentorship Match

  6 Weeks Survey (T2) + 12 Weeks Survey (T3) - Appa Complete ONLY

Study Arms (3)

Appa Complete

EXPERIMENTAL

Participants in this arm will be granted access to Appa Complete (i.e., weekly mentorship + CBT videos).

Behavioral: Appa Complete

Appa Lite

ACTIVE COMPARATOR

Participants in this arm will be granted access to Appa Lite (i.e., CBT videos without weekly mentorship).

Behavioral: Appa Lite

Waiting List Control

NO INTERVENTION

Participants in this arm will be given a mental health resources packet. In 12 weeks (after the study period), they will be granted access to Appa Lite.

Interventions

Appa Complete BEHAVIORAL

Weekly mentorship meetings \& guided CBT videos. Participants assigned to Appa Complete will have unlimited access to the Appa website and materials described in Appa Lite, along with weekly mentorship meetings with a trained and supervised near-peer mentor with whom they have been matched. Matching is based on preference for mentor gender, racial/ethnic minority status, and LGBTQ status and is designed to increase the sense of identification with the mentor and peer-mentor alliance. Virtual meetings begin with a review and discussion of the video and other materials for the week. Mentors ask about how clients are incorporating their CBT learnings into their life, share ways they have used the focal skills in their own lives, illustrate skills use in popular culture, and provide problem solving strategies. Each week has a specific prompt to ensure that clients are applying the concepts and skills they are learning and can talk about any questions or reflections with their mentors.

Appa Complete

Appa Lite BEHAVIORAL

Unguided EBP videos and materials. Participants assigned to the Appa Lite condition will have unlimited access to the Appa website, including short form CBT-based videos and materials such as an emotions wheel pdf and thoughts, feelings, and behavior worksheets. The website is structured so that the materials are presented in a developmentally appropriate manner consistent with evidence-based principles in a 12-week format, beginning with general psychoeducation to define mental health, proceeding to introducing CBT and basic CBT skills such as identifying thoughts, feelings, and behaviors, layering on applying specific CBT skills, and ending with reflective journal exercises. Client progress through the materials will be completely unguided.

Appa Lite

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 18 years old
• Generalized Anxiety Disorder screen or Patient Health Questionnaire screen scores of 10 or higher
• Living in the United States
• Speak English
• Read/comprehend English at a 5th grade level or higher (treatment delivery is in English)
• Able to appropriately and independently engage with study intervention (i.e., without parental support)
• \- Must be a caregiver (e.g., parent, grandparent, custodian) of a youth participant in the study
• \- Must be a mentor with a youth mentee in the study
• \- Must supervise a mentor with a mentee in the study

You may not qualify if:

• Psychotic disorders
• Substance use disorders
• Active engagement in self-harm
• Active suicidal ideation (intent or plan)

Sponsors & Collaborators

• Appa Health: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Appa Health

Oakland, California, 94618, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Michelle Kaufman, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Robert Miller, JD

  Appa Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: February 12, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 20, 2025

Record last verified: 2025-06

Locations

US (1)