Clinical trial NCT02275715: Treatment of Feeding Problems in Children With Autism
Official title: Treatment of Feeding Problems in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment of Feeding Problems in Children With ASD
Keywords: autism spectrum disorder (ASD)
feeding problems
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Rochester
name: National Institute of Mental Health (NIMH)
First posted: 2014-10-27
Enrollment: 54
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

1. Males and females \>=2 and \< 8 years of age.
2. At least one participating parent resides with the child \>50% of time.
3. 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).
4. 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.
5. A receptive language level of 12 months or greater. \[Rationale: diagnostic uncertainty of ASD in children functioning below 12 months of age and the need for the child to understand simple instructions in PT-F\].
6. 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

1. Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of Rett's Disorder or Childhood Disintegrative Disorder.
2. 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). \[Rationale: these children may require different treatments than the behaviorally based parent training intervention\].
3. Significant oral motor dysfunction (i.e., unable to safely chew and swallow age appropriate textures).
4. Presence of known psychiatric diagnosis in the child that would require a different treatment (e.g., psychotic disorder, major depression).
5. Inpatient hospitalization.
6. Being fed via nasogastric or gastrostomy tube in the past year.
7. On medication or supplements specifically targeting appetite.
8. Insufficient proficiency of English language prohibiting comprehension of PT-F. \[Rationale: Parents will need sufficient command of English to benefit from the English materials\].

Primary outcomes:
measure: Number of Subjects with Complete Data
timeFrame: Week 20
measure: Treatment Fidelity
timeFrame: Week 20
measure: Parent Adherence
timeFrame: Week 20
Secondary outcomes:
measure: Brief Autism Mealtime Behavior Inventory (BAMBI)
timeFrame: Baseline, Week 10, Week 20
Other outcomes:
measure: Parent Functioning
timeFrame: Baseline, Week 10, Week 20
measure: Interfering Behaviors at Mealtime
timeFrame: Baseline, Week 10, Week 20
measure: Healthy Eating Index
timeFrame: Baseline, Week 10, Week 20
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Florida
name: Cynthia R Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: