Status:
COMPLETED
Treatment of Feeding Problems in Children With Autism
Lead Sponsor:
University of Florida
Collaborating Sponsors:
University of Rochester
National Institute of Mental Health (NIMH)
Conditions:
Treatment of Feeding Problems in Children With ASD
Eligibility:
All Genders
2-7 years
Phase:
NA
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 asses...
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, day...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and females \>=2 and \< 8 years of age.
- At least one participating parent resides with the child \>50% of time.
- Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of Autism Spectrum Disorder as established by clinical assessment, corroborated by the Autism Diagnostic Interview - Revised (ADI-R) and Autism Diagnostic Observation Schedule - 2nd Edition (ADOS2).
- A total score of \> 54 on the Brief Autism Mealtime Behavior Inventory. A score of 54 is one standard deviation above the mean for the ASD group, as reported by the developers.
- A receptive language level of 12 months or greater. \[Rationale: diagnostic uncertainty of ASD in children functioning below 12 months of age and the need for the child to understand simple instructions in PT-F\].
- Medication free or stable medications and/or supplements (no changes in past 6 weeks and no planned changes during study period). \[Rationale: Many children with ASD are on medications to target associated behaviors. These include stimulants and atypical antipsychotics. Excluding these children could result in a non-representative sample of children with ASD and feeding problems. We will require that the feeding problems pre-date the initiation of medications / supplements\].
- Exclusion Criteria
- Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of Rett's Disorder or Childhood Disintegrative Disorder.
- Presence of a known serious medical condition in the child influencing the management of diet and treatment impacting diet or appetite (e.g., current or past gastroesophageal reflux disease, significant food allergies, diabetes, cystic fibrosis, celiac disease, endocrine disorder, genetic disorders known to impact growth or appetite). \[Rationale: these children may require different treatments than the behaviorally based parent training intervention\].
- Significant oral motor dysfunction (i.e., unable to safely chew and swallow age appropriate textures).
- Presence of known psychiatric diagnosis in the child that would require a different treatment (e.g., psychotic disorder, major depression).
- Inpatient hospitalization.
- Being fed via nasogastric or gastrostomy tube in the past year.
- On medication or supplements specifically targeting appetite.
- Insufficient proficiency of English language prohibiting comprehension of PT-F. \[Rationale: Parents will need sufficient command of English to benefit from the English materials\].
Exclusion
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2017
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02275715
Start Date
February 1 2015
End Date
June 25 2017
Last Update
April 5 2018
Active Locations (2)
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1
University of Florida
Gainesville, Florida, United States, 32611
2
University of Rochester
Rochester, New York, United States, 14627