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Active, Not Recruiting

NCT Number: NCT07176481

Diné Parents Taking Action Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Spectrum Disorder Child Development Disorders, Pervasive Developmental Disabilities Developmental Disability Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Health Sciences - Northern Arizona University

Flagstaff, Arizona, 86011, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Parent Knowledge of Evidence-Based Strategies

    Time frame: 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.

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

  2. Child Social Communication

    Time frame: 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.

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

  3. Frequency Using Intervention Strategies

    Time frame: 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.

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

  4. Family Outcomes

    Time frame: 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.

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

Secondary outcomes

  1. Child problem behavior

    Time frame: 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.

    Mean score on the Nisonger Child Behavior Rating Form, an assessment of problematic behavior in children (Aman et al., 1996).

  2. Service Use

    Time frame: 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.

    Number and type of services the child has received.

  3. Autism Parenting Stress

    Time frame: 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.

    Mean score on the Autism Parenting Stress Index (Silva & Schalock, 2012).

  4. Parent Health Literacy

    Time frame: 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.

    Mean score on the BRIEF Health Literacy Measure (Sand-Jecklin, & Coyle, 2014).

  5. Parent Depression

    Time frame: 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-reported depressive symptoms using the Center for Epidemiological Studies Depression Scale (CES-D).

Sponsors and collaborators

Lead sponsor

Northern Arizona University

Other

Collaborators

  • Mercy Care

Registry information

Official study title

Parents Taking Action to Improve Autism Services Access for Navajo Families in Northern Arizona: Intervention Adaptation and Pilot Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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