Autism
Conditions
Keywords
Autism, Environmental modifications, Modifiable lifestyle factors, Parent coaching, Parent education
Brief summary
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.
Interventions
BEHAVIORALParent education and coaching program for newly diagnosed autism
Education and coaching program for parents of children with newly diagnosed autism that is focused on modifiable lifestyle factors and environmental modifications.
Sponsors
Documenting Hope Project
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
1. Child from 3-7 years of age 2. Child has autism diagnosis featuring evaluation with the Autism Diagnostic Observation Schedule, 2nd Edition \[ADOS-2\], Childhood Autism Rating Scale, Second Edition (CARS-2), or Autism Diagnostic Interview - Revised (ADI-R) within the last 18 months 3. Child has an Autism Treatment Evaluation Checklist (ATEC) score at screening of between 50 and 120 (generally considered moderate/severe autism) 4. Child and parents live in the United States 5. Parent has ability to speak and read English 6. Parents are willing to fulfill study expectations 7. Child has not yet engaged in comprehensive diet, lifestyle, and environmental interventions for autism
Exclusion criteria
1. Parents who are unwilling or unable to make lifestyle changes, such as significant dietary changes 2. Parents who are unwilling or unable to participate in study activities, such as group and individual coaching 3. Parents who hold beliefs that are incompatible with an education and lifestyle intervention 4. Child who requires significant specialty medical care, including routine or frequent in-patient medical treatment, are currently taking mood stabilizing drugs, and/or who have cancer or a pre-cancerous condition 5. Child who has been diagnosed with complex conditions in addition to autism, such as an inborn error of metabolism identified through genetic testing, or a known chromosomal disorder 6. Parents who are unable or unwilling to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Autism Treatment Evaluation Checklist (ATEC) | Assessed at baseline, six months, 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavior Assessment System for Children, Third Edition (BASC-3) | Assessed at baseline, 6 months, and 12 months | Score range: 0 to 100. Interpretation: Lower scores indicate fewer problematic behaviors. |
| Short Sensory Profile 2 | Assessed at baseline, 6 months, and 12 months | Raw scores are converted to percentiles. Lower scores indicate fewer sensory behaviors. |
| Children's Sleep Habits Questionnaire (CSHQ) | Assessed at baseline, 6 months, and 12 months | Score range 45-135. Lower scores indicate less sleep disturbance. |
| Goodenough Assessment of Child Drawing | Assessed at baseline, 6 months, and 12 months | Scores range from 40 to 160. Higher scores indicate greater developmental level. |
| Automated Self-Administered 24-hour Dietary Assessment Tool (ASA-24) | Assessed at baseline, 6 months, and 12 months. | No single summed score, as food intake is assessed without maximums or minimums. Lower intake of ultraprocessed foods is the desired outcome. |
Countries
United States
Outcome results
None listed