Diné Parents Taking Action Trial

NCT07176481 | Active Not Recruiting

• 1 other identifier: 1620944
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a family support program helps Navajo parents and guardians of children with autism spectrum disorder (ASD) or other developmental concerns. The main questions it aims to answer are:

• Is the program something families find useful and easy to take part in?
• Does the program raise parents' knowledge and confidence in using strategies that support their child's development?
• Does the program help children improve in areas such as social communication? Researchers will compare two groups:
• One group of parents will join the program right away.
• The other group will join the program after waiting. Participants will:
• Be randomly placed into the "immediate" or "waitlist control" group using simple randomization.
• Take part in sessions led by trained Navajo Family Advisors, who are parents of children with ASD.
• Learn and practice strategies they can use at home to support their child
• Answer surveys about their experience, knowledge, and their child's progress

Conditions

Autism Spectrum Disorder (ASD); Developmental Disability

Keywords

Autism Spectrum Disorder (ASD); Parent Training Program; Navajo/Diné

Outcome Measures

Primary Outcomes (4)

• Parent Knowledge of Evidence-Based Strategies

  Mean score on a parent-report survey assessing comprehension and confidence using strategies taught in the program.

  Immediate intervention group: Baseline, immediate post-intervention, and 2-months post-intervention. Waitlist intervention group: Baseline, 2-months after baseline, and 2-months after second assessment.

• Child Social Communication

  Mean score on the Social Communication Questionnaire (Rutter, Bailey, \& Lord, 2003), a parent-report survey assessing their child's social communication skills.

  Immediate intervention group: Baseline, immediate post-intervention, and 2-months post-intervention. Waitlist intervention group: Baseline, 2-months after baseline, and 2-months after second assessment.

• Frequency Using Intervention Strategies

  Mean score on a parent-report survey assessing the frequency of use of the learned intervention strategies.

  Immediate intervention group: Baseline, immediate post-intervention, and 2-months post-intervention. Waitlist intervention group: Baseline, 2-months after baseline, and 2-months after second assessment.

• Family Outcomes

  Mean score on the Family Outcomes Survey-Revised, a parent-reported measure of their child's strengths, needs, and abilities (Waschl et al., 2021).

  Immediate intervention group: Baseline, immediate post-intervention, and 2-months post-intervention. Waitlist intervention group: Baseline, 2-months after baseline, and 2-months after second assessment.

Secondary Outcomes (5)

• Child problem behavior

  Immediate intervention group: Baseline, immediate post-intervention, and 2-months post-intervention. Waitlist intervention group: Baseline, 2-months after baseline, and 2-months after second assessment.

• Service Use

  Immediate intervention group: Baseline, immediate post-intervention, and 2-months post-intervention. Waitlist intervention group: Baseline, 2-months after baseline, and 2-months after second assessment.

• Autism Parenting Stress

  Immediate intervention group: Baseline, immediate post-intervention, and 2-months post-intervention. Waitlist intervention group: Baseline, 2-months after baseline, and 2-months after second assessment.

• Parent Health Literacy

  Immediate intervention group: Baseline, immediate post-intervention, and 2-months post-intervention. Waitlist intervention group: Baseline, 2-months after baseline, and 2-months after second assessment.

• Parent Depression

  Immediate intervention group: Baseline, immediate post-intervention, and 2-months post-intervention. Waitlist intervention group: Baseline, 2-months after baseline, and 2-months after second assessment.

Study Arms (2)

Immediate Group

EXPERIMENTAL

Participants in this arm will begin the adapted parent training program right away. The program is delivered by trained Navajo Family Advisors who are parents of older children with autism spectrum disorder (ASD). Parents/guardians of children ages 2-12 years with ASD or related developmental concerns will take part in group sessions that focus on learning and practicing evidence-based strategies to support their child's development and family well-being.

Behavioral: Diné Parents Taking Action Program

Waitlist Control Group

NO INTERVENTION

Participants in this arm will be placed on a waitlist and will not begin the program during the initial study period. After the waiting period, they will be offered the adapted parent training program delivered by trained Navajo Family Advisors.

Interventions

Diné Parents Taking Action Program BEHAVIORAL

A culturally adapted parent training program delivered by trained Navajo Family Advisors, focused on teaching parents/guardians evidence-based strategies to support their child's development and family well-being.

Immediate Group

Eligibility Criteria

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

You may qualify if:

• Parent/legal guardian of a child between 2 and 12 years of age.
• Child received a diagnosis of autism spectrum disorder (ASD) OR a developmental disability.
• Parent/guardian identifies as Navajo/Diné.

You may not qualify if:

• Parent/guardian is 17 years or younger.
• Child is 13 years or older.
• Child did not receive an ASD diagnosis or a developmental disability diagnosis.
• Parent/guardian does not identify as Navajo/Diné.

Sponsors & Collaborators

• Northern Arizona University: lead
• Mercy Care: collaborator

Study Sites (1)

Department of Health Sciences - Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Developmental Disabilities

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Olivia Lindly, Ph.D., M.P.H.

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Health Sciences

Model Details: Participants were randomly assigned to one of two groups: immediate intervention or a waitlist control group (intervention later).

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: August 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)