Autism MEAL Plan: Parent Training to Manage Eating Aversions & Limited Variety
NCT ID: NCT02712281
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2016-07-31
2018-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Autism MEAL Plan
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).
Autism MEAL Plan
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.
Parent Education
Parents of eligible children who are randomized to the Parent Education Arm will receive group-based parent education (PE). Each group includes 4 parents.
Parent Education
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.
Interventions
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Autism MEAL Plan
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.
Parent Education
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Complex medical issues (e.g., gastrostomy tube or formula dependent) requiring intensive treatment such as day treatment or hospital-based treatment
3 Years
8 Years
ALL
No
Sponsors
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Children's Healthcare of Atlanta
OTHER
Emory University
OTHER
Responsible Party
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William Sharp, PhD
Assistant Professor
Principal Investigators
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William Sharp, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Marcus Autism Center
Atlanta, Georgia, United States
Countries
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References
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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.
Other Identifiers
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IRB00085811
Identifier Type: -
Identifier Source: org_study_id