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| Name | Class |
|---|---|
| Mercy Care | UNKNOWN |
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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:
Researchers will compare two groups:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Child problem behavior | Mean score on the Nisonger Child Behavior Rating Form, an assessment of problematic behavior in children (Aman et al., 1996). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivia Lindly, Ph.D., M.P.H. | Northern Arizona University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Health Sciences - Northern Arizona University | Flagstaff | Arizona | 86011 | United States |
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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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002658 | Developmental Disabilities |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Participants were randomly assigned to one of two groups: immediate intervention or a waitlist control group (intervention later).
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| Service Use | Number and type of services the child has received. | 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). | 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). | 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). | 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. |