PODER Familiar: A Health Promotion Intervention for Latino Families of Children With Intellectual and Developmental Disabilities
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
- 是
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
Sandy Magaña
Professor
University of Texas at Austin
