Harnessing Network Science to Personalize Scalable Interventions for Adolescent Depression: Do Idiographic Symptom Structures Predict Response to Single Session Interventions?
试验速览
- 阶段
- 不适用
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change in adolescent depressive symptom severity
研究概览
简要总结
We will recruit 216 subjects meeting the eligibility criteria. After completing a baseline battery session via secure video conferencing and 3-week phone survey period, adolescents will be randomly assigned to receive 1 of 3 web-based single session interventions (SSIs) at a second secure video conference session. This second session for the intervention will take place within 2-3 weeks after the phone survey period. Immediately pre- and post-SSI, adolescents will complete a limited number of self-report questionnaires to index shifts in proximal outcomes. Participants, both adult and youth, will complete additional follow-up questionnaires 3, 6, 12, 18, and 24 months post-intervention. Participants will complete the intervention, including the pre- and post- SSI questionnaires, and follow-up surveys on their own.
详细描述
216 eligible adolescents, along with one accompanying parent, will complete a Qualtrics baseline battery via a secure video-conference platform. This battery will be followed by a 3-week (ESM) period. In preparation for this 3-week period, adolescents with a personal smartphone will be assisted in downloading the ecological sampling method (ESM) app during the initial lab session. The participants will then receive an ESM tutorial, and a research team member will review each survey question with the adolescent to ensure comprehension. At the end of the initial session, participating families will schedule a second, brief meeting with the lab to help the adolescent set up the online intervention, which will be completed after the ESM period.
During the ESM period following the baseline battery, adolescents will be prompted to complete the same 2-minute, 8-item survey 5 times per day for 21 days, via a smartphone-based, encrypted data collection app (LifeData). Notifications to complete surveys will occur every 2-3 hours. Responses will be deemed valid if completed within 2 hour of notification, ensuring at least 1-hour lags between surveys.
Once the 3-week ESM period is complete, adolescents will be randomly assigned to receive 1 of 3 web-based single session interventions (SSIs) at a second secure video conference session. The second video conference session will be brief and is meant to help adolescents access the online intervention, which they will complete by themselves. This second session will take place within 2-3 weeks after the ESM period. Immediately pre- and post-SSI, adolescents will complete a limited number of self-report questionnaires by themselves to index shifts in proximal outcomes.
The adolescent and parent pairs will, on their own, complete follow-up assessments at post-intervention. These assessments are abridged versions of the baseline battery. To enable longitudinal analysis of outcome trajectories, adolescents and parents will complete online follow-up questionnaires (including subjective reports of clinical and functional outcomes) 3, 6, 12, 18, and 24 months post-intervention. All follow-up surveys will be completed via Qualtrics, through personalized links sent to the family.
All families will be debriefed by email, and the intervention SSI condition assignment will be revealed, after 24-month follow-up is complete. At this time, adolescents will be offered the opportunity to remotely complete the SSIs they did not originally receive.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomized to the Behavioral Activation SSI (BA-SSI), Growth Mindset SSI (GM-SSI), or the Supportive Therapy SSI (ST-SSI; each 30 minutes in length).
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 11-16 (inclusive) at the time of study enrollment
- •Has one parent or legal guardian willing to participate in the study
- •Speaks English well enough to complete the smartphone-based questionnaire
- •Comfort with smartphone-based surveys
- •Indication of elevated risk for youth depression, one of two ways (or both ways): (a) elevations in depressive symptoms, at least 80th percentile or higher, based on parent-report CDI 2; (b) received treatment for depression within the previous 2 years
排除标准
- •Fail to meet the above-listed inclusion criteria
- •Exit the study prior to condition randomization
- •Respond with either copy/pasted responses from text earlier in the intervention to any of free response questions
- •Obvious lack of English fluency in open response questions
- •Responding with random text in open response questions
- •Duplicate responses from the same individual in baseline or follow-up surveys
- •Provide responses of fewer than 3 words to writing prompts that ask for at least 2 sentences or more
研究组 & 干预措施
Supportive Therapy SSI (ST-SSI)
The web-based supportive therapy (ST-SSI) intervention, called the Sharing Feelings Intervention, is designed to mimic supportive therapy (ST). The goals of the ST intervention are to encourage participants to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. In previous clinical trials, ST has resulted in significantly fewer reductions in youth internalizing problems compared to cognitive-behavioral and growth mindset interventions. The ST-SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the other SSIs.
干预措施: Supportive Therapy SSI (Behavioral)
Behavioral Activation SSI (BA-SSI)
The BA-SSI include 5 elements: (1) An introduction to the program's rationale: that engaging in value-based activities can combat sad mood and low self-esteem; (2) Psychoeducation about depression, including how behavior shapes feelings and thoughts; (3) A life values assessment, where youth identify key areas from which they draw enjoyment and meaning; (4) Creation of an activity hierarchy, where youth identify and personalize (in guided exercises) 3 activities to target for change; and (5) An exercise in which youths write about benefits that might result from engaging in each activity; an obstacle that might keep them from doing the activities; and a strategy for overcoming identified obstacles.
干预措施: Behavioral Activation SSI (Behavioral)
Growth Mindset SSI (GM-SSI)
Program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable Further stories by older youths, describing times when they used "growth mindsets" to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change.
干预措施: Growth Mindset SSI (Behavioral)
结局指标
主要结局
Change in adolescent depressive symptom severity
时间窗: Pre-intervention to 3-month follow-up; Pre-intervention to 6-month follow-up; Pre-intervention to 12-month follow-up; Pre-intervention to 18-month follow-up; Pre-intervention to 24-month follow-up
The Children's Depression Inventory (CDI) 2 - short form (CDI-SF) is a reliable, valid measure of youth-reported depression severity, normed for youth age and sex and yielding raw and T scores.
次要结局
- Changes in parent-reported adolescent symptom severity(Pre-intervention to 3-month follow-up; Pre-intervention to 6-month follow-up; Pre-intervention to 12-month follow-up; Pre-intervention to 18-month follow-up; Pre-intervention to 24-month follow-up)
研究者
Jessica Schleider
Assistant Professor of Psychology
Stony Brook University