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临床试验/NCT05353751
NCT05353751已完成不适用

Examining the Effectiveness of a Mindfulness-based Intervention for Underserved Adolescents With and Without Caregiver Involvement

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年5月31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
32
试验地点
1
主要终点
SCARED -Screen for child anxiety and related emotional disorders

研究概览

简要总结

Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective interventions. Participation in mindfulness interventions has been demonstrated to reduce anxiety and depressive symptoms among teenagers. Parents' participation in mindfulness interventions has also been shown to reduce their children's mental health symptoms. However, there is no available evidence regarding potential additional benefits for adolescents' mental health of having both the adolescent and their parent or caregiver learn and practice mindfulness simultaneously.

This pilot intervention study aims to explore potential additive effects of parent/caregiver participation in a digitally-based, kindness-focused, coached mindfulness intervention program for adolescents that lasts 9 weeks. Participating parent/caregiver-child pairs (n = 30) will include one teenager between 12 and 17 years old with a current diagnosis of an anxiety or depressive disorder and one parent/caregiver. All adolescent participants will take part in the mindfulness intervention. Half of the parents/caregivers will be randomized to also take part in the mindfulness program. Outcomes will be compared between families in which only the teen participates in the mindfulness program and families in which the teen and parent/caregiver participate in the intervention.

Adolescents and parents/caregivers will take part in evaluations before, in the middle of, and after the end of the mindfulness program, meaning that participation in the study will take a total of approximately 12 weeks. Pre, mid, and post evaluations will include online questionnaires. Pre and post evaluations will also include clinical interviews via phone or video conference. Evaluations will include measures of mental health diagnoses and symptoms, mood, interpersonal and family functioning, mindfulness, and perceptions of/satisfaction with the program. Participating adolescents and parents/caregivers will also fill out weekly brief questionnaires of anxiety and depressive symptoms. The primary outcome of interest is adolescent mental health, including anxiety and depressive symptoms.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Participants will include:
  • one adolescent (aged 12-17 years) with a current diagnosis of an anxiety or depressive disorder)
  • one of their parents/caregivers.
  • Both adolescent and caregiver must speak English to the degree necessary to participate in the intervention program, which is only available in English.
  • Parent and youth must have a smart phone and be willing to download the online mindfulness program.

排除标准

  • Exclusion criteria apply to both caregiver and adolescent and include:
  • current alcohol or substance use disorder or suicidality
  • lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay diagnosed by an independent evaluator;
  • English reading level below 4th grade
  • non English speaking
  • currently receiving mindfulness-based mental health services or taking medication to treat anxiety or depression.

结局指标

主要结局

SCARED -Screen for child anxiety and related emotional disorders

时间窗: 12-14 weeks after baseline assessment

self report of anxiety symptoms

Generalized Anxiety Disorder-7

时间窗: 12-14 weeks after baseline assessment

self report of anxiety symptoms

Patient Health Questionnaire-9

时间窗: 12-14 weeks after baseline assessment

self report of depressive symptoms

次要结局

  • Kiddie Schedule for Affective Disorders and Schizophrenia interview -anxiety and depressive disorder modules(12-14 weeks after baseline assessment)

研究者

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

Denise A. Chavira, PhD

Professor

University of California, Los Angeles

研究点 (1)

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