Implementation of the Parents Taking Action in Paraguay

NCT05780138 | Unknown

• 1 other identifier: STUDY00004046
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Autism

Keywords

international research; autism; developmental disabilities; caregiver training

Outcome Measures

Primary Outcomes (5)

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

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

  from baseline to 4 months

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

  Change from baseline caregivers' depression at 4 months

  from baseline to 4 months

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

  Change from baseline caregivers' depression at 4

  : from baseline to 4 months

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

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

  from baseline to 4 months

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

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

  from baseline to 4 months

Study Arms (1)

Intervention group

EXPERIMENTAL

Participants will receive 10 remote sessions with the curriculum

Behavioral: Parents Taking Action

Interventions

Parents Taking Action BEHAVIORAL

Educational intervention designed to provide caregivers of children with autism information about autism, and strategies to advocate and support their child's development.

Intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Depression; Autistic Disorder; Developmental Disabilities

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sandy Magana, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana K Terol, MEd

CONTACT

3129752242; aterol2@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post-test intervention study

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: December 16, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after the completion of the study
• Access Criteria: Researcher from a recognized institution

Locations

US (1)