Suspended

Support Program for Navajo Families with Autism in Northern Arizona

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What is being tested

Diné Parents Taking Action Program

Behavioral
Who is being recruted

Autism Spectrum Disorder
+2

+ Mental Disorders
+ Developmental Disabilities
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorNorthern Arizona University
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2024Actual date on which the first participant was enrolled.

This clinical trial focuses on a family support program designed to assist Navajo parents and guardians who have children with autism spectrum disorder (ASD) or other developmental challenges. The study seeks to determine if the program is helpful and convenient for families to participate in. It aims to see if participating in the program increases parents' understanding and confidence in using techniques to help their child's development, and if it results in improvements in children’s social communication skills. This study is particularly important as it could lead to better support services for Navajo families, who may face unique challenges in accessing autism-related resources. Participants in this study are divided into two groups. One group begins the program immediately, while the other group waits to start. Participants are randomly assigned to these groups. The program includes sessions led by Navajo Family Advisors, who are themselves parents of children with ASD. These advisors guide the participants in learning strategies to support their children's development at home. Throughout the trial, parents complete surveys to share their experiences, evaluate what they have learned, and report on their child’s progress. This approach helps researchers understand the effectiveness and practicality of the program.

Official TitleParents Taking Action to Improve Autism Services Access for Navajo Families in Northern Arizona: Intervention Adaptation and Pilot Trial 
NCT07176481
Principal SponsorNorthern Arizona University
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
29 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Autism Spectrum Disorder
Mental Disorders
Developmental Disabilities
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.

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.
Study Objectives
Primary Objectives

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

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

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

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 Objectives

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

Number and type of services the child has received.

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

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

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Department of Health Sciences - Northern Arizona UniversityFlagstaff, United StatesSee the location
SuspendedOne Study Center
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