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临床试验/NCT05818397
NCT05818397已完成不适用

Nurturing Compassionate Responding Towards Oneself and Others Through the Caregiver-child Relationship

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Change in number of dyads in attendance each week

研究概览

简要总结

The Self-Compassion for Children and Caregivers Study aims to understand if an online course designed to help kids and their caregivers learn self-compassion is feasible, enjoyable, and helpful for well-being and relationships in families from diverse backgrounds. Children ages 8-11 who have a caregiver willing to participate with them will:

  • Attend 2 in-person study visits (about 1-1.5 hour each) that includes

  • A survey for caregiver and child

  • A brief computer puzzle challengetask while heart rate and sweat is recorded (child)

  • A brief discussion about how the challenge went

  • Participate in a 6-session, online self-compassion course with other families (see back)

  • Provide feedback about how the course went

详细描述

This pilot study examines the feasibility, acceptability, and preliminary outcomes of the Self-Compassion for Children and Caregivers (SCCC) program. Twenty-four children ages 8-11 and a primary caregiver will be recruited from a racially diverse school community to participate in 6 1-hour group intervention sessions over 6 weeks. Feasibility and acceptability data will guide program refinements; pre and post assessments will explore dimensional changes in anxiety/depression symptoms as well as potential physiological, relational/behavioral changes associated with SCCC participation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •English speaking:
  • •Youth between the ages of 8 and 11 years old
  • •Youth are currently attending an elementary school in the Madison Metropolitan School District (MMSD).
  • •Accompanied by a willing and able caregiver (e.g., parent, grandparent, legal guardian)
  • •Access to an internet-enabled device
  • •Both parent and youth participants must be able to read/write in English
  • •Meet threshold (T greater than 59) for clinically significant anxiety and/or depression from either parent- or youth-report of symptoms
  • •Inclusion Criteria - Spanish speaking:
  • •Youth between the ages of 8 and 11 years old
  • •Accompanied by an eligible caregiver participant
  • •Safe access to a computer or mobile device that can connect to the internet
  • •Visual acuity adequate to read text on a computer or mobile device
  • •Able to provide assent and complete surveys in Spanish

排除标准

  • •English speaking:
  • •Are unable to provide adequate informed consent and/or assent
  • •Parent or youth that is currently impaired by any medical condition that would prevent study participation
  • •Active self-reported psychotic disorder
  • •Current use of psychotropic medication is not exclusionary. However, certain medications that may impact physiology recordings may be excluded (e.g. those with direct impacts on the sympathetic nervous system). Exclusionary medications will be decided on a case-by-case basis, per discretion of the PI, a pediatric psychiatrist
  • •Exclusion Criteria - Spanish speaking:
  • •Previous completion of a Mindfulness and Self-Compassion for children and Caregivers (MSC-CC) program

研究组 & 干预措施

Self-Compassion Intervention - English speaking

Experimental

干预措施: Self-Compassion for Children and Caregivers (SCCC) (Behavioral)

Self-Compassion Intervention - Spanish speaking

Experimental

干预措施: Self-Compassion for Children and Caregivers (SCCC) (Behavioral)

结局指标

主要结局

Change in number of dyads in attendance each week

时间窗: Week 1 to week 6

Feasibility and acceptability will be measured using attendance records each week of the program

Fidelity to SCCC Curriculum

时间窗: Through study completion, up to 2 years

The SCCC Fidelity Checklist is a subjective checklist for evidence shown for an array of items covered during each session. No evidence, some evidence, and definite evidence are selected, with higher counts of definite evidence reflecting greater fidelity to the curriculum.

Reasons for study attrition

时间窗: Up to week 6

Feasibility and acceptability will be assessed through reasons provided by dyads for leaving the program

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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