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临床试验/NCT03783533
NCT03783533已完成不适用

Designing and Evaluating an Asynchronous Remote Communication Approach to Behavioral Activation With Clinicians and Adolescents At Risk for Depression

University of Washington2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
User Burden Scale

研究概览

简要总结

This project aims to use an asynchronous remote communities (ARC) approach both to discover the design requirements for adapting Behavioral Activation (BA) to ARC as well as design/build an ARC platform for administering BA. The investigators will test the feasibility of our approach in a small feasibility observational study with clinicians and adolescents.

详细描述

An estimated 3.1 million adolescents are diagnosed with depression (MDD) each year (SAMHSA, 2016), and adolescent onset MDD is associated with chronic physical, mental and psychosocial disability (Birmaher et al., 1996). However, over 60% of adolescents with MDD do not receive mental health care, and, among those who do, treatment engagement is low (SAMHSA, 2016; Olfson et al., 2003). Behavioral Activation (BA) is an evidence-based psychosocial intervention (EBPI) for individuals with MDD (Dimidjian et al., 2006). While BA holds promise as an effective treatment with adolescents (McCauley et al., 2015, 2016), previous research approaches have found that adolescents may be better reached and engaged through social media, mobile technologies, and other technology platforms (Boyd, 2007; Park & Calamaro, 2013). In addition, BA requires frequent interaction from patients over time, which can be difficult and costly for clinicians to administer directly. Thus, there is an opportunity to improve usability and engagement of EBPIs via new technology-based tools. Asynchronous Remote Communities (ARC) is a promising technology-based approach for engaging adolescents that capitalizes on the reach of technology while also providing support, social interactions, and motivation to engage. ARCs are technology-mediated groups that use private online platforms to deliver weekly tasks to participants and gather information about perceptions in a format that is lightweight, accessible, usable, and low burden. The investigators aim to use ARC both to discover the design requirements for adapting BA to ARC as well as design/build an ARC platform for administering BA. The investigators will test the feasibility of our approach in a small feasibility study with clinicians and adolescents. The investigators propose the following specific aims:

Aim 1: Use the ARC approach with adolescents, primary care physicians, and mental health specialists to discover target user needs, design constraints and to observe their experience with ARC: The investigators will first use ARC to collect target user (i.e., primary care providers (PCP) and mental health specialists, adolescents at risk for depression) data to understand their needs and the facilitators and barriers to adapting BA to ARC.

Aim 2: Design & build an ARC platform for BA delivery with adolescents: Once the investigators have a strong understanding of the facilitators and barriers, the investigators will design a platform to use the ARC approach for BA delivery via Slack. The investigators will use an iterative design approach to understand the technical feasibility of the approach, whether and how to automate parts of the BA intervention using chatbots and other custom applications within Slack. The investigators will conduct small, informal usability testing with target users during this stage.

Aim 3: Test feasibility and usability with small pilot groups of adolescent and clinician target users: Once the investigators have a robust enough prototype of the ARC delivery platform for BA, the investigators will conduct a small pilot study with adolescents at-risk for depression and clinicians to assess the feasibility and usability of the approach. The investigators will collect data on the feasibility, usability, user burden, acceptability, and symptom outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adolescents with PHQ-9 scores between 5 and 15 (Mild to Moderate Range) who do not report current suicidality (Pine et al., 1999) will be recruited from clinician target users' practice settings.

排除标准

  • Current suicidal ideation or PHQ-9 scores that are below or above the cutoff described above for adolescents.

结局指标

主要结局

User Burden Scale

时间窗: Measured within 3-weeks post BA App User Testing

Assesses the burden of the intervention adaptation with both clinician and adolescent participants across several domains and ranges from 0 to 80 for a total score with higher scores indicating higher burden. Scores were averaged across subscales including: * Access Burden * Emotional Burden * Financial Burden * Mental Burden * Physical Burden * Privacy Burden * Social Burden * Time Burden

Appropriateness of Intervention Measure

时间窗: Measured within 3-week post BA App User Testing

This is a survey measure that assesses the appropriateness of the intervention adaptation with both clinician and adolescent participants. Scores range from 4 to 20 with higher scores indicating higher appropriateness.

Feasibility of Intervention Measure

时间窗: Measured within 3-week post BA App User Testing

This is a survey measure that assesses the feasibility of the intervention adaptation with both clinician and adolescent participants. Scores range from 4 to 20 with higher scores indicating higher feasibility.

Patient Health Questionnaire-Adolescent (PHQ-8)

时间窗: Measured within 3-weeks post BA App User Testing

Measures symptoms of adolescent depression; Scores range from 0 to 24 with higher scores indicating higher depression symptoms.

Acceptability of Intervention Measure

时间窗: Measured within 3-weeks post BA App User Testing

This is a survey measure that assesses the acceptability of the intervention adaptation with both clinician and adolescent participants. Scores range from 4 to 20 with higher scores indicating higher acceptability.

次要结局

  • Platform Engagement(Measuring platform engagement across 35 days of platform use.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Jenness

Acting Assistant Professor

University of Washington

研究点 (2)

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