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临床试验/NCT06138730
NCT06138730进行中(未招募)不适用

Digital Delivery of Evidence-Based Mental Health Content and Mentoring to Adolescents

Appa Health2 个研究点 分布在 1 个国家目标入组 475 人开始时间: 2024年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
475
试验地点
2
主要终点
Youth-Reported Psychosocial Functioning

研究概览

简要总结

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.

详细描述

Pilot Study (1 year). Optimize Study Procedures and Participant Retention (6 months). In an initial pilot study with N=75 youth, the researchers will examine the adapted Appa Health and research study content, offering data for optimization and retention incentive decisions prior to larger scale RCT through the following research questions (RQs): RQ 1.1: Are research and incentive protocols sufficient for recruiting and retaining adolescents in the study, and how can they be optimized? RQ 1.2. Do Appa's modified engagement strategies developed in preliminary studies increase use of CBT video content? This pilot study will enable the research team to identify and address any problems in recruitment, study procedures, and retention prior to the effectiveness trial.

Setting. The study will be carried out within the Appa Health remote platform, which comprises over 20 trained youth mentors serving, on average, 400 youth every 3 months. Clients come primarily from school-based partnerships. Appa has several existing school partners who refer students to Appa either through a paid partnership from the school or through access to parents of students.

Recruitment and Randomization. Participants will be recruited from the Appa Health client population using email outreach. As described in the Commercialization Plan, the Appa client base from individual paying clients, school systems, and B2B customers is expected to be sufficient to meet this goal within the study timeframe. Screening of youth using the PHQ-8 and GAD is standard protocol for Appa; those who score above 10 on either instrument will be invited to participate in the study. Due to the relatively small sample size of the pilot trial, the research team will use stratified random sampling to ensure approximate balance to the three study conditions on baseline covariates (gender, age, baseline severity on GAD & PHQ-8, race/ethnicity, and LGBTQ status), with stratification blocks created via nearest neighbor matching on all variables.

Interventions. Youth will be randomized to three conditions, which in the larger RCT will enable analyses of the main effect of the traditional Appa package as compared to a waiting list control group, as well as exploring the impact of a light touch version of Appa for commercial purposes. This will also permit examination of the impact of the two components on specific psychosocial mechanisms, as appropriate in an experimental therapeutics paradigm.

"Appa Lite": 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 13 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)
  • Inclusion Criteria (Caregivers):
  • - Must be a caregiver (e.g., parent, grandparent, custodian) of a youth participant in the study
  • Inclusion Criteria (Mentors):
  • - Must be a mentor with a youth mentee in the study
  • Inclusion Criteria (Supervisors):
  • - Must supervise a mentor with a mentee in the study

排除标准

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

结局指标

主要结局

Youth-Reported Psychosocial Functioning

时间窗: Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

Youth TOP Problems Scale

Youth-Reported Self-Efficacy for CBT

时间窗: Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

Self-Efficacy for CBT Scale

Youth-Reported Use of CBT

时间窗: Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3)

Skills of Cognitive Therapy Measure (SCT)

次要结局

  • Youth-Reported Depressive Symptoms(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 Anxiety Symptoms(Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3))
  • Youth-Reported Existential Isolation(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))
  • Caregiver-Reported Youth Psychosocial Functioning(Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3))
  • Caregiver-Reported Strain(Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3))
  • Caregiver-Reported Financial Burden(Baseline (T1) + 6 Weeks Survey (T2) + 12 Weeks Survey (T3))

研究者

发起方
Appa Health
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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