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临床试验/NCT04030897
NCT04030897Unknown不适用

Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Evaluation of Web-based, Single-session Interventions for Parents and Youths

Stony Brook University1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2020年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
246
试验地点
1
主要终点
Mental Health Treatment-Seeking Behavior Checklist

研究概览

简要总结

Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality. The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, <50% of youth with MD access treatment. Thus, a need exists for interventions that are feasible for youths and parents to access and complete-and that may strengthen parents' likelihood of pursuing longer-term services. Single-session interventions (SSIs) may help forward these goals. SSIs include elements of comprehensive treatments, but their brevity makes them easier to disseminate at scale. Meta-analytic evidence suggests SSIs can reduce youth psychopathology, including self-administered (e.g., online) SSIs. One computer-based SSI, teaching growth mindset (GM; viewing personal traits as malleable), has reduced adolescent depressive symptoms in multiple RCTs; GM-SSIs have also improved parents' expectancies that psychotherapy could benefit their children's mental health. This project will test whether these online, youth- and parent-directed GM-SSIs-designed to reduce youth depressive symptoms and improve parents' mental health treatment expectancies, respectively-may increase mental health service access, reduce youth depressive symptoms, and relieve parental stress following PC-based youth MD screening. Youths reporting elevated MD symptoms at PC visits (N = 200) will receive either Information/Psychoeducation/Referral (IPR) or IPR plus parent- and youth-directed GM-SSIs (IPR+SSI). The investigators will examine whether IPR+SSI, versus IPR alone, increases MD service access; reduces parental stress; and reduces youth depressive symptoms across three months. Results may yield a disseminable model for promoting youth treatment access after PC-based depression screening.

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 (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Participating youths and parents will be aware of whether they are receiving the online interventions immediately or after the 3-month follow-up period (i.e., whether they are in the 'intervention group' or the 'waitlist group'). However, participating families will be assigned to these conditions via an online survey, which they complete remotely, and condition assignments will be unknown to the research team and the youth's primary care provider.

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

  • •Youth is between the ages of 11 and 16, inclusive, at the time of study recruitment
  • •Youth reports a Pediatric Symptom Checklist 'Internalizing' score of 5 or higher (out of 10) at her/his most recent pediatric primary care visit at 1 of the 9 Stony Brook University-affiliated clinics participating in this study
  • •Parent and youth are comfortable with reading and writing in English
  • •Parent and youth are comfortable with online activity

排除标准

  • •Parent or youth is not comfortable reading and/or writing in English
  • •Parent or youth is not comfortable with online activity

研究组 & 干预措施

Online Programs + Information/Psychoeducation/Referral (IPR)

Active Comparator

Includes 2 online, one-session programs (one for youths; one for parents) and Primary Care-based IPR. The 30-min, self-administered YOUTH PROGRAM includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable, due to the brain's plasticity; 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. In the 15-min Qualtrics-based PARENT PROGRAM, parents read 2 scientific passages on (1) the notion that emotions are flexible in youth and adults, and (2) that failure promotes personal growth. After each passage, parents write a persuasive summary of its main arguments, directed to fellow parents who may benefit from the information.

干预措施: Parent-Directed Online Single-Session Program (Behavioral)

Online Programs + Information/Psychoeducation/Referral (IPR)

Active Comparator

Includes 2 online, one-session programs (one for youths; one for parents) and Primary Care-based IPR. The 30-min, self-administered YOUTH PROGRAM includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable, due to the brain's plasticity; 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. In the 15-min Qualtrics-based PARENT PROGRAM, parents read 2 scientific passages on (1) the notion that emotions are flexible in youth and adults, and (2) that failure promotes personal growth. After each passage, parents write a persuasive summary of its main arguments, directed to fellow parents who may benefit from the information.

干预措施: Youth-Directed Online Single-Session Program (Behavioral)

Online Programs + Information/Psychoeducation/Referral (IPR)

Active Comparator

Includes 2 online, one-session programs (one for youths; one for parents) and Primary Care-based IPR. The 30-min, self-administered YOUTH PROGRAM includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable, due to the brain's plasticity; 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. In the 15-min Qualtrics-based PARENT PROGRAM, parents read 2 scientific passages on (1) the notion that emotions are flexible in youth and adults, and (2) that failure promotes personal growth. After each passage, parents write a persuasive summary of its main arguments, directed to fellow parents who may benefit from the information.

干预措施: Information/Psychoeducation/Referral (Behavioral)

Information/Psychoeducation/Referral (IPR; usual care control)

Placebo Comparator

Information, Psychoeducation and Referral (IPR) represents usual care in the Stony Brook University Hospital's Pediatric Primary Care Division. Families of a youth with elevated MD symptoms during a PC visit receive a folder containing informational materials about the nature of depression and referrals to providers in their area. All families in this study will receive PC-based IPR.

干预措施: Information/Psychoeducation/Referral (Behavioral)

结局指标

主要结局

Mental Health Treatment-Seeking Behavior Checklist

时间窗: Baseline to 3-month follow-up

At baseline and 3-month follow-up, parents will indicate whether they have engaged in each of four treatment-seeking behaviors for their child: researched local mental healthcare providers/agencies for their child; contacted a mental healthcare provider or agency about treatment for their child; contacted child's school regarding mental health supports for their child; and scheduled an appointment OR placed child on a waiting-list with a mental healthcare provider/agency. Total number of treatment-seeking behaviors between baseline and 3-month follow-up may range from 0 to 4. Individual behaviors are self-reported by parents on as 'yes' or 'no' (noting whether they engaged in the behavior during the study period). At baseline, parents will report on whether they engaged in these behaviors 'since the child's last doctor's appointment.' At follow-up, parents will report whether they have engaged in these behaviors 'since their past survey, 3 months ago.'

Change in Children's Depression Inventory 2 - Youth Report Total Score

时间窗: Baseline to 3-month follow-up.

Change in youth reported depressive symptoms, total score derived from 28-item CDI-2. Scores range from 0-56, with higher scores indicating higher levels of depression.

次要结局

  • Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report)(Baseline to 3-month follow-up.)
  • Change in Pediatric Symptom Checklist - Youth-Report Total score(Baseline to 3-month follow-up.)
  • Change in Pediatric Symptom Checklist- Parent Report Total score(Baseline to 3-month follow-up.)
  • Change in Attitudes Toward Therapy Scale - Parent(Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).)
  • Mental Health Treatment Access at 3-month follow-up(3-month follow-up)
  • Change in Beck Hopelessness Scale - 4 (Parent Report)(Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).)
  • Change in Barriers to Accessing Care Evaluation (BACE)(Baseline to 3-month follow-up)
  • Change in Perceived Stress Scale(Baseline to 3-month follow-up)
  • Change in Beck Hopelessness Scale - 4 (Youth Report)(Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).)
  • Change in Brief Symptom Inventory - 18(Baseline to 3-month follow-up)
  • Change in Pediatric Symptom Checklist - Youth-Report Internalizing Score(Baseline to 3-month follow-up.)
  • Change in Children's Depression Inventory 2 - Parent Report total score(Baseline to 3-month follow-up.)

研究者

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

Jessica Schleider

Assistant Professor of Psychology

Stony Brook University

研究点 (1)

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