Treatment of Feeding Problems in Children With Autism

Not Applicable

Completed

• Conditions: Treatment of Feeding Problems in Children With ASD
• Interventions: Behavioral: Parent Training Program

• Registration Number: NCT02275715
• Lead Sponsor: University of Florida

Brief Summary

The primary aim of the project is to develop and pilot a manualized, individually delivered Parent Training Program for Feeding Problems (PT-F) in children with autism spectrum disorder (ASD) to assess feasibility and parent acceptance of the program. The secondary aim of the project is to assess the success of the PT-F program in improving mealtime behavior problems when compared to the wait-list control.

Exploratory aims include obtaining preliminary data on the impact of PT-F on child and parent functioning (reducing parent stress and improving parent sense of competency and parent-child interactions at mealtime), assessing the impact of treatment on interfering behaviors around mealtime/snack times, and measuring nutritional improvements after treatment.

Detailed Description

Fifty well characterized children will be randomly assigned to either the 20 week PT-F or a waitlist control group. Study assessments evaluating feeding and mealtime behaviors, nutritional intake, daytime behaviors, repetitive behaviors, sensory sensitivities, parent stress and parent-child interactions will be completed at Baseline, Week 10, and Week 20 timepoints. Treatment Fidelity forms will be completed by the therapist at the end of each treatment session to assess achievement of session goals and parent adherence during each session.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-27
• Study Start: 2015-02
• Primary Completion: 2017-01-25
• Study Completion: 2017-06-25
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent Training Program (PT-F)	Parent Training Program	Treatment group

Primary Outcome Measures

Name	Time	Method
Number of Subjects with Complete Data	Week 20	Measure of feasibility of randomized controlled trial by successful recruitment of 50 subjects with complete data collected from \> 80% (\> 40) subjects.
Treatment Fidelity	Week 20	Measure of therapists' ability to deliver PT-F with \> 80% average fidelity as rated by fidelity checklists
Parent Adherence	Week 20	Measure of parent adherence to the intervention as evidenced by average attendance of \> 80% of scheduled sessions and successful completion of \> 70% of session activities as rated from adherence checklists.

Secondary Outcome Measures

Name	Time	Method
Brief Autism Mealtime Behavior Inventory (BAMBI)	Baseline, Week 10, Week 20	Measure of mealtime behavior problems

Trial Locations

Locations (2)

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Rochester; 🇺🇸 Rochester, New York, United States