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The primary purpose of this study is to evaluate the feasibility and effectiveness of an education and coaching program for parents of children with newly diagnosed autism that is focused on modifiable lifestyle factors and environmental modifications. A single-arm, open-label, prospective study will be conducted evaluating the feasibility and effectiveness of the 12-month education and health coaching intervention for parents as an adjuvant to comprehensive clinical care for 12 newly diagnosed children with autism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent education and coaching program for newly diagnosed autism | Experimental | Education and coaching program for parents of children with newly diagnosed autism focused on modifiable lifestyle factors and environmental modifications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent education and coaching program for newly diagnosed autism | Behavioral | Education and coaching program for parents of children with newly diagnosed autism that is focused on modifiable lifestyle factors and environmental modifications. |
| Measure | Description | Time Frame |
|---|---|---|
| Autism Treatment Evaluation Checklist (ATEC) | The assessment consists of four subtests: Speech/Language Communication (14 items), Sociability (20 items), Sensory/Cognitive Awareness (18 items), and Health/Physical/Behavior (25 items). Each item is rated on a scale from 0 (no problem) to 3 (severe problem), with total scores ranging from 0 to 180. Lower scores indicate less autism symptom severity. | Assessed at baseline, six months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Behavior Assessment System for Children, Third Edition (BASC-3) | Score range: 0 to 100. Interpretation: Lower scores indicate fewer problematic behaviors. | Assessed at baseline, 6 months, and 12 months |
| Short Sensory Profile 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Parenting Stress Index-Short Form (PSI-SF) | Total scores range from 36-180. Lower scores indicate less parental stress. | Assessed at baseline, 6 months, and 12 months. |
| Quick Environmental Exposure and Sensitivity Inventory (QEESI) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FLIGHT Study Administration | Contact | 833-935-5543 | info@documentinghope.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Documenting Hope | Recruiting | Windsor | Connecticut | 06095 | United States |
This study of outcomes among children with autism represents a vulnerable population.
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Raw scores are converted to percentiles. Lower scores indicate fewer sensory behaviors.
| Assessed at baseline, 6 months, and 12 months |
| Children's Sleep Habits Questionnaire (CSHQ) | Score range 45-135. Lower scores indicate less sleep disturbance. | Assessed at baseline, 6 months, and 12 months |
| Goodenough Assessment of Child Drawing | Scores range from 40 to 160. Higher scores indicate greater developmental level. | Assessed at baseline, 6 months, and 12 months |
| Automated Self-Administered 24-hour Dietary Assessment Tool (ASA-24) | No single summed score, as food intake is assessed without maximums or minimums. Lower intake of ultraprocessed foods is the desired outcome. | Assessed at baseline, 6 months, and 12 months. |
Scores range from 0-100 for each scale. Lower scores indicate less severe symptoms.
| Assessed at baseline, 6 months, and 12 months. |
| Environmental toxin and functional laboratory panel | Exploratory analysis of environmental toxin and functional laboratory panel. Higher levels indicate worse environmental toxin and functional status. A composite toxin burden ("low", "medium", "high") will be assessed across the panel. | Assessed at baseline, 6 months, and 12 months |