Diet and Behavior in Young Children With Autism

Study Overview
=================
Brief Summary
-----------------
This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.

Detailed Description
-----------------
Autism is a serious brain disorder that affects brain development and often causes social and educational problems. Prior studies suggested that a gluten- and casein-free diet may have a therapeutic effect on the behavior of children with autism. This study will examine the effects of such a diet on the behavior of children with autism who meet research diagnostic criteria, are monitored in adherence to the diet, and receive similar intense behavioral therapy. Children in this study will be following a gluten free and casein free diet for 18 weeks. All subjects will have 6 weeks of baseline followed by 12 weeks of randomized, double-blind, placebo-controlled, challenge snacks with careful behavioral observation and evaluation. They also will be receiving uniform educational and behavioral services through their provider. Standard autism evaluation methods, weekly diet and sleep diaries and scheduled laboratory tests will be used to assess subjects. An end of study, follow-up assessment will be completed at 30 weeks after the start of the study.

Official Title
-----------------
Diet and Behavior in Young Children With Autism

Conditions
-----------------
Autism, Autistic Disorder

Intervention / Treatment
-----------------
* Behavioral: Gluten- and casein-free diet
* Behavioral: Placebo controlled diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Autism spectrum disorder or pervasive developmental disorder, ADI-R and ADOS positive. Participation in applied behavioral analysis classes for at least 4 months, with at least 10 hours per week of service, and at least 1 hour of service in the home A score higher than 30 on the Mullen Early Learning scale Ability to maintain a gluten- and casein-free diet during the study In order to maintain study integrity, and due to frequent child assessments, enrollment is limited to a select population within the Rochester area

Ages Eligible for Study
-----------------
Minimum Age: 30 Months
Maximum Age: 54 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will follow a gluten-free and casein-free diet for 18 weeks. The compliance with the diet was monitored with 24 hour dietary recall and nutritional sufficiency with diet diary analysis. | Behavioral: Gluten- and casein-free diet<br>* Participants will follow a gluten-free and casein-free diet for 18 weeks. All children received individual EIBI interventions to decrease the confound of different types of therapies.<br>|
| Active Comparator: 2<br>After established on a gluten free and casein free diet for at least 6 weeks, participants received double blind, placebo controlled challenges containing gluten, casein, gluten+casein, or placebo in a random order. Data was collected on behavioral and physiologic responses relative to the challenges. Children remained on the gluten free and casein free diet throughout this period. | Behavioral: Placebo controlled diet<br>* Participants will follow a gluten-free and casein-free diet for 18 weeks. They will receive double blind placebo controlled challenge snacks that contain gluten, casein, gluten+casein or placebo with measurement of response. They remain on the gluten free and casein free diet for the entire study period.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of the gluten free casein free diet | Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition | Measured at Weeks 6,18 and 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Casein, Autism, Applied Behavioral Analysis, Gluten