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Clinical Trials/NCT02275715
NCT02275715
Completed
N/A

Treatment of Feeding Problems in Children With Autism

University of Florida2 sites in 1 country54 target enrollmentFebruary 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Treatment of Feeding Problems in Children With ASD
Sponsor
University of Florida
Enrollment
54
Locations
2
Primary Endpoint
Number of Subjects with Complete Data
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
June 25, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of Subjects with Complete Data

Time Frame: 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

Time Frame: Week 20

Measure of therapists' ability to deliver PT-F with \> 80% average fidelity as rated by fidelity checklists

Parent Adherence

Time Frame: 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 Outcomes

  • Brief Autism Mealtime Behavior Inventory (BAMBI)(Baseline, Week 10, Week 20)

Study Sites (2)

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