Autism Spectrum Disorder (ASD)NCT07176481
Diné Parents Taking Action Trial
A study testing Diné Parents Taking Action Program in people with Autism Spectrum Disorder (ASD) and Developmental Disability, run by Northern Arizona University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Developmental Disability
- What is being tested?
- Diné Parents Taking Action Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health Sciences - Northern Arizona University
Flagstaff, Arizona, 86011
About this study
Official title: Parents Taking Action to Improve Autism Services Access for Navajo Families in Northern Arizona: Intervention Adaptation and Pilot 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?
Read more
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
- Being tested
- Diné Parents Taking Action Program
- Keywords
- Autism Spectrum Disorder (ASD), Parent Training Program, Navajo/Diné
- Medical subject headings
- Autism Spectrum Disorder, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diné Parents Taking Action ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Knowledge of Evidence-Based Strategies
Mean score on a parent-report survey assessing comprehension and confidence using strategies taught in the program.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Mean score on the Nisonger Child Behavior Rating Form, an assessment of problematic behavior in children (Aman et al., 1996).
Measured: 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
Number and type of services the child has received.
Measured: 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
Mean score on the Autism Parenting Stress Index (Silva \& Schalock, 2012).
Measured: 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
Mean score on the BRIEF Health Literacy Measure (Sand-Jecklin, \& Coyle, 2014).
Measured: 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
Parent-reported depressive symptoms using the Center for Epidemiological Studies Depression Scale (CES-D).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Aug 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two groups: immediate intervention or a waitlist control group (intervention later).
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Collaborators
- Mercy Care
- Responsible party
- Principal investigator, Olivia Lindly, Northern Arizona University
- Investigators
- Olivia Lindly, Ph.D., M.P.H., Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176481
- Sponsor's protocol ID
- 1620944
- Status last verified
- Aug 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the policies from the Navajo Nation Human Research Review Board (NNHRRB), all data will go back and belong to the NNHRRB. Individual participant data will not be shared with other researchers for this study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents Taking Action to Improve Autism Services Access for Navajo Families in Northern Arizona: Intervention Adaptation and Pilot Trial
- ClinicalTrials.gov ID
- NCT07176481
- Acronym / sponsor ID
- 1620944
- Keywords
- Autism Spectrum Disorder (ASD), Parent Training Program, Navajo/Diné
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Collaborators
- Mercy Care
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two groups: immediate intervention or a waitlist control group (intervention later).
| Arm | Type | Receives |
|---|---|---|
| Immediate Group | Experimental | Behavioral: Diné Parents Taking Action ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diné Parents Taking Action ProgramA 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. | Behavioural | Immediate Group |
Primary outcome
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.
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.
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.
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).
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No. Given the policies from the Navajo Nation Human Research Review Board (NNHRRB), all data will go back and belong to the NNHRRB. Individual participant data will not be shared with other researchers for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivia Lindly, Ph.D., M.P.H. principal investigator
Northern Arizona University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diné Parents Taking Action Program in people with Autism Spectrum Disorder (ASD) and Developmental Disability, run by Northern Arizona University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.