Autism MEAL Plan: Parent Training to Manage Eating Aversions & Limited Variety

NCT02712281 | Completed DMC

• 1 other identifier: IRB00085811
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a group-based parent training intervention designed to assist parents in increasing the variety of foods eaten in children with Autism Spectrum Disorder (ASD). The goal of the Autism MEAL Plan is to include specific techniques to manage mealtime behavioral challenges and introduce new foods.

Conditions

Autism Spectrum Disorder

Keywords

Food Selectivity; Autism MEAL Plan; Parent Education

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Global Impression - Improvement scale (CGI-I) score

  The Clinical Global Impression - Improvement scale (CGI-I) is a 7-point scale measure of overall change of Parent Target Problems (the child's two most pressing problems at screening, as reported by parents), using scores from the Clinical Global Impressions - Severity scale (CGI-S). Scores range from 1 (Very Much Improved) through 4 (Unchanged) to 7 (Very Much Worse).

  Baseline, end of follow-up (up to 18 weeks)

Secondary Outcomes (14)

• Change in Parenting Stress Index- Short Form (PSI) score

  Baseline, end of follow-up (up to 18 weeks)

• Parent Satisfaction Rating

  Week 14

• Change in Brief Autism Mealtime Behavior Inventory (BAMBI) scores

  Baseline, end of follow-up (up to 18 weeks)

• Change in Food Preference Inventory (FPI) scores

  Baseline, end of follow-up (up to 18 weeks)

• Change in nutritional intake

  Baseline, end of follow-up (up to 18 weeks)

Study Arms (2)

Autism MEAL Plan

EXPERIMENTAL

Parents of eligible children who are randomized to the Autism Managing Eating Aversions and Limited variety (MEAL) Plan will participate in group-based parent training sessions (4 parents per group).

Behavioral: Autism MEAL Plan

Parent Education

ACTIVE COMPARATOR

Parents of eligible children who are randomized to the Parent Education Arm will receive group-based parent education (PE). Each group includes 4 parents.

Behavioral: Parent Education

Interventions

Autism MEAL Plan BEHAVIORAL

The Autism MEAL plan includes education on feeding issues and behavior management, and specific strategies to expand dietary diversity. Each parent receives 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician. The first three sessions focus on understanding feeding problems and behavior management strategies in children with ASD.The next seven sessions include child-specific feeding interventions, based on parent-report and home data collection of child meal time behavior. To promote application of new skills, homework accompanies each lesson. The next seven sessions include child-specific feeding interventions, based on parent-report and home data collection of child meal time behavior. To promote application of new skills, homework accompanies each lesson.

Autism MEAL Plan

Parent Education BEHAVIORAL

The Parent Education study arm includes 10 sessions focusing on the following topics: understanding Autism Spectrum Disorder (ASD), clinical assessments for ASD, development in children with ASD, medical and genetic comorbidities in ASD, family and sibling issues, treatment alternatives, and education and treatment planning. The Parent Education arm does not include topics related to feeding problems or feeding specific interventions. Each parent receives 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician. Children randomized to Parent Education will be offered the Autism MEAL Plan after completing the 10-week randomized trial.

Parent Education

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A diagnosis of autism spectrum disorder (ASD), supported by the Autism Diagnostic Observation Schedule (ADOS) and the Social Communication Questionnaire (SCQ)-Lifetime
• Presents with a history of moderate food selectivity (a diet involving at least 6 food items)
• Accepting at least one fruit or vegetable
• Fewer than two food items in one or more food categories (i.e., fruit, vegetable, protein, starch) as measured by the Food Preference Inventory
• Exhibits disruptive refusal behaviors when presented with non-preferred foods (e.g., crying, active verbal protest, tantrums) often or during every meal as indicated by item 7 on the Brief Autism Mealtime Behavior Inventory (BAMBI)
• Parent, or primary caregiver, endorses a feeding concern as one of the top two problems on the Parent Target Problem
• Parent, or primary caregiver, agrees to participate and is deemed able to attend group sessions
• Parent, or primary caregiver, is able to speak, understand, read and write in English

You may not qualify if:

• Severe feeding problems (e.g., \< 5 preferred foods as measure by the Food Preference Inventory)
• Complex medical issues (e.g., gastrostomy tube or formula dependent) requiring intensive treatment such as day treatment or hospital-based treatment

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

• Sharp WG, Burrell TL, Berry RC, Stubbs KH, McCracken CE, Gillespie SE, Scahill L. The Autism Managing Eating Aversions and Limited Variety Plan vs Parent Education: A Randomized Clinical Trial. J Pediatr. 2019 Aug;211:185-192.e1. doi: 10.1016/j.jpeds.2019.03.046. Epub 2019 May 3.

  PMID: 31056202 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• William Sharp, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 18, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)