Clinical trial NCT02712281: Autism MEAL Plan: Parent Training to Manage Eating Aversions & Limited Variety
Official title: Autism MEAL Plan: Parent Training to Manage Eating Aversions & Limited Variety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Food Selectivity
Autism MEAL Plan
Parent Education
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
First posted: 2016-03-18
Enrollment: 38
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a structured parent-mediated, group-based intervention to reduce mealtime disruptive behavior, expand dietary diversity and reduce parental stress associated with moderate food selectivity in young children with Autism Spectrum Disorder (ASD).

Children ages 3-8 with a diagnosis of ASD who present with moderate food selectivity and associated problem behavior will be screened for inclusion in the study. Following consent and screening procedures, parents of eligible children will be assigned to a group-based parent training (Autism MEAL plan) or group-based parent education. Each parent will receive 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician.

Data will be collected on parental compliance with the Autism MEAL plan and the food acceptance of the child as well as nutritional intake, and refusal behaviors. Child participants will also be included in parent-child dyad in-vivo feedback sessions. Parents assigned to parent education will be able to cross-over to receive the Autism MEAL Plan following completion of post-study measures.

The first aim of the study is to finalize the Autism MEAL Plan materials (e.g., role-play activities, activity sheets and video examples). This includes standardizing therapist scripts in line with the revised curriculum and creating new video examples that coincide with practice worksheets. Home recording (e.g., personal camera phone) to document and present home meal data will also be added to the curriculum.

The second aim is to evaluate the feasibility of the Autism MEAL Plan versus parent education in 40 children (20 per treatment assignment) with ASD and moderate feeding problems.

The final study aim is to evaluate the preliminary efficacy of the Autism MEAL Plan in expanding food diversity, decreasing disruptive behavior and reducing parental stress compared to Parent Education. Methods of evaluating this aim include direct observation, parent ratings of behavior, food intake and stress, as well as blinded clinician ratings, height, weight and BMI.

Eligibility criteria: Inclusion Criteria (for children):

* 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)

Inclusion Criteria (for parents or primary caregivers):

* 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

Exclusion Criteria (for children):

* 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

Primary outcomes:
measure: Change in Clinical Global Impression - Improvement scale (CGI-I) score
timeFrame: Baseline, end of follow-up (up to 18 weeks)
Secondary outcomes:
measure: Change in Parenting Stress Index- Short Form (PSI) score
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Parent Satisfaction Rating
timeFrame: Week 14
measure: Change in Brief Autism Mealtime Behavior Inventory (BAMBI) scores
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Change in Food Preference Inventory (FPI) scores
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Change in nutritional intake
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Change in Aberrant Behavior Checklist (ABC) scores
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Change in rapid acceptance during 10 minute meal observation
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Change in rapid swallowing during 10-minute meal observation
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Change in disruptions during 10-minute meal observation
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Change in crying during 10-minute meal observation
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Change in volume of food consumed during 10-minute meal observation
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Weight
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Height
timeFrame: Baseline, end of follow-up (up to 18 weeks)
measure: Body Mass Index
timeFrame: Baseline, end of follow-up (up to 18 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory University
name: William Sharp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.