PODER Familiar: Health Promotion for Latino Families of Children With IDD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-100
SponsorUniversity of Texas at Austin

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Child uses mobility aid

Trial design

Design model

Parallel

Treatments tested in this trial

  • PODER Familiar

    Behavioral

    Educational intervention designed to improve healthy behaviors of families of children with intellectual and developmental disabilities.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change from baseline parent Body Mass Index at 4 months

Weight and height measurement

Time frame
from baseline to 4 months
2

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

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

Time frame
from baseline to 4 months
3

Change from baseline parent psychological distress at 4 months

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

Time frame
from baseline to 4 months
4

Change from baseline child body mass index percentile at 4 months

weight and height measurement

Time frame
from baseline to 4 months

Secondary outcomes

1

Change from baseline parent physical activity at 4 months

ActiGraph accelerometer, measures 4 categories: sedentary, light, moderate, vigorous PA

Time frame
from baseline to 4 months
2

Change from baseline parent dietary Intake at 4 months

Dietary Screener Questionnaire (DSQ) intake of fruit, vegetables, dairy, sugars, \& whole grains

Time frame
from baseline to 4 months
3

Change from baseline child physical activity at 4 months

ActiGraph accelerometer, measures 4 categories: sedentary, light, moderate, vigorous PA

Time frame
from baseline to 4 months
4

Change from baseline child dietary Intake at 4 months

Dietary Screener Questionnaire (DSQ) intake of fruit, vegetables, dairy, sugars, \& grains

Time frame
from baseline to 4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas at Austin

Lead sponsor

University of Illinois at Chicago

Collaborator