跳至主要内容
临床试验/NCT05780138
NCT05780138招募中不适用

Implementation of the Parents Taking Action With Caregivers of Young Autistic Children in Paraguay

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Social Communication Questionnaire, 40-items, 0-40, higher is worst

研究概览

简要总结

The principal aim of this study is to conduct a single group design pilot of a psychoeducational caregiver training (i.e., culturally adapted Parents Taking Action) with a group of family caregivers of young children with autism in Paraguay. The following research questions will be addressed:

Research Question #1: What is the feasibility and acceptability of the intervention? Research Question #2: Do participants improve between pre and post-test on outcome measures? Parents will receive 10 weekly remote sessions on information about autism and strategies to support their child's development. The weekly sessions will be held via telehealth by the researcher and 2 and 2 Paraguayan trained parents of autistic individuals.

详细描述

The adapted intervention, Parents Taking Action, will consist of 10 weekly online group sessions among family caregivers, the researcher, and 2 Paraguayan trained parents of autistic individuals (Promotoras). The weekly remote sessions will be conducted on a video-chat platform, in Spanish (See Appendix A for curriculum outline).

The promotoras who deliver the sessions will be Paraguayan and will offer the sessions in Spanish. Promotoras will receive 10 hours of training on content and procedures prior to the beginning of the intervention.

Piloting the Intervention The Pilot will consist of a one group pre and post-test design with no control group.

Sample and Recruitment. Twenty family caregivers in Paraguay will be recruited for this pilot study. Primary caregivers are the ones who do most of the care and parenting of the child. Family caregivers will be recruited and will be eligible if (1) they live in Paraguay, (2) are the primary caregivers of a child with autism who is 0-8 years old, and (3) are18 years old or older. All recruitment materials will be in Spanish. Families who express interest in participation will be contacted by a trained research assistant to complete consent forms and to schedule the baseline assessment. After a cohort of 10 to 20 families have been recruited, the pilot intervention will be scheduled.

Data Source/Data Collection. Parents/ family caregivers will complete objective and self-report assessments at baseline and post-intervention follow-up through telephone or videochat interviews with trained students. One interview will be conducted at baseline and one at follow-up to collect the full battery of measures. See Appendix B for a list of the measures. Participants will not receive any compensation to participate in the study. After completing the intervention, family caregivers will be invited to attend an additional individual interview in which we will seek feedback on the social validity of the content and delivery of the intervention. Interviews will be held in Spanish.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Live in Paraguay
  • Be a parent or primary family caregiver
  • Be 18 years old or older
  • Child has a diagnosis of autism
  • Child is between 2 and 8 years old

排除标准

  • Primary Language is not Spanish
  • Does not have access to a device with connection to the internet

结局指标

主要结局

Social Communication Questionnaire, 40-items, 0-40, higher is worst

时间窗: from baseline to 4 months

Change from baseline caregiver -reported social communication questionnaire at 4 months

Epidemiological Studies -Depression, 20 items, minimum 0 maximum 60, higher worse.

时间窗: from baseline to 4 months

Change from baseline caregivers' depression at 4 months

Family Outcome Measure, 24 items, range 0 to 120. Higher better

时间窗: from baseline to 4 months

Change from baseline helping and supporting their child at 4 months,

caregivers' empowerment to use different caregiving strategies, 11 items, 0-44, higher is better

时间窗: : from baseline to 4 months

Change from baseline caregivers' depression at 4

Caregiver Knowledge Questionnaire, 40 items, 0-40 higher is better

时间窗: from baseline to 4 months

Change from baseline caregivers' knowledge about autism at 4 months.

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 (2)

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