FLIGHT - Autism: Education and Health Coaching Program Focused on Modifiable Lifestyle Factors for Parents

Documenting Hope Project

Status: Not yet enrolling

Conditions: Autism

Treatments: Behavioral: Parent education and coaching program for newly diagnosed autism

Study type: Interventional

Funder types: Other

Identifiers

NCT07375537

DH-002

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Child from 3-7 years of age
2. Child has autism diagnosis (score on the Autism Diagnostic Observation Schedule, 2nd Edition [ADOS-2] ≥ 7) within the last 12 months
3. Child has an Autism Treatment Evaluation Checklist (ATEC) score at screening of between 50 and 79 (considered Level II autism requiring substantial support)
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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Parent education and coaching program for newly diagnosed autism

Experimental group

Description:

Education and coaching program for parents of children with newly diagnosed autism focused on modifiable lifestyle factors and environmental modifications

Treatment:

Behavioral: Parent education and coaching program for newly diagnosed autism