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临床试验/NCT05713617
NCT05713617招募中不适用

PODER Familiar: A Health Promotion Intervention for Latino Families of Children With Intellectual and Developmental Disabilities

University of Texas at Austin4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年1月17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
90
试验地点
4
主要终点
Change from baseline parent Body Mass Index at 4 months

研究概览

简要总结

The goal of this clinical trial is to test a culturally tailored health promotion intervention for children with IDD and their families. First investigators will conduct a single group design pilot study of a health promotion intervention, followed by second, a small-scale randomized control trial (RCT). of the intervention with Latino parents of children with intellectual and developmental disabilities (IDD) in the Chicago, Illinois and Austin, Texas areas. The following research questions will be addressed:

Question 1: What is the appropriate content, dosage, and delivery method of the intervention?

Question 2: What is the feasibility and acceptability of the intervention?

Question 3: Do participants improve between pre and post-test on outcome measures both in the one group design and compared to the control group in the RCT?

Parents will receive 10 weekly remote sessions on health promotion content delivered by parent mentors called promotoras. Parents and children will attend 3 multi-family group workshops in-person that will provide demonstrations and interactive activities.

详细描述

PODER Familiar will consist of 10 weekly remote one-on-one sessions with the parent and the promotora, and 3 monthly multi-group family sessions to be held in-person. The weekly remote sessions will be conducted on a video-chat platform The multi-group family sessions will be held at a community friendly location (a community center or space at a community organization) in which 3 to 5 families will attend. Family units will consist of the parent and child with IDD and other family members who wish to attend (other parent, siblings, etc.). Group sessions will reinforce content covered in the curriculum through interactive activities and demonstrations.

The promotoras who deliver the weekly sessions will be bilingual and will also be parents of children with IDD. They will offer the sessions in the language of preference of the participant. Promotoras will receive 15 hours of training on content and procedures. Individual sessions will be audio-recorded and reviewed for fidelity, training and consistency.

The group sessions will be conducted by the PIs and graduate students at each site. Groups will be conducted in Spanish and English.

Phase I: Piloting the Intervention (Research Questions 1 &2) Phase I will consist of a one group pre and post-test design with no control group.

Sample and Recruitment. Thirty Latino families will be recruited for the pilot study (15 in Chicago, and 15 in Austin). Community organizations will help recruit eligible families using an informational flyer about the study and an accompanying verbal recruitment script. All recruitment materials will be translated to Spanish. Families who express interest in participation will be contacted by a trained bilingual research assistant to complete consent forms and to schedule the baseline assessment. After a cohort of 15 families has been recruited at each site, the pilot intervention will be scheduled.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Assessors will be independent from the intervention team and will not know the group condition of the participants

入排标准

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

入选标准

  • Parent/Caregiver
  • identify as parent or primary family caregiver
  • 18 years of age or older
  • Identify as Latino/a or of Latin American Descent
  • have a child with IDD between 6 and 17 years of age Child with IDD
  • between 6 and 17 years old
  • the child has a diagnosis of autism spectrum disorder, Down syndrome or intellectual disability

排除标准

  • Child uses mobility aid

结局指标

主要结局

Change from baseline parent Body Mass Index at 4 months

时间窗: from baseline to 4 months

Weight and height measurement

Change from baseline parent health-related quality of life at 4 months

时间窗: from baseline to 4 months

PROMIS Global Health (parent); minimum 9 maximum 45, higher better

Change from baseline parent psychological distress at 4 months

时间窗: from baseline to 4 months

Center for Epidemiological Studies - Depression, minimum 0 maximum 60, higher worse

Change from baseline child body mass index percentile at 4 months

时间窗: from baseline to 4 months

weight and height measurement

Change from baseline child health related quality of life at 4 months

时间窗: from baseline to 4 months

PROMIS Pediatric Scale Global, minimum 7, maximum 35, higher better

次要结局

  • Change from baseline child physical activity at 4 months(from baseline to 4 months)
  • Change from baseline child dietary Intake at 4 months(from baseline to 4 months)
  • Change from baseline parent physical activity at 4 months(from baseline to 4 months)
  • Change from baseline parent dietary Intake at 4 months(from baseline to 4 months)

研究者

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

Sandy Magaña

Professor

University of Texas at Austin

研究点 (4)

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