Treatment of Feeding Problems in Children With Autism

NCT02275715 | Completed DMC

• 1 other identifier: IRB201400831-N
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Treatment of Feeding Problems in Children With ASD

Keywords

autism spectrum disorder (ASD); feeding problems

Outcome Measures

Primary Outcomes (3)

• Number of Subjects with Complete Data

  Measure of feasibility of randomized controlled trial by successful recruitment of 50 subjects with complete data collected from \> 80% (\> 40) subjects.

  Week 20

• Treatment Fidelity

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

  Week 20

• Parent Adherence

  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.

  Week 20

Secondary Outcomes (1)

• Brief Autism Mealtime Behavior Inventory (BAMBI)

  Baseline, Week 10, Week 20

Other Outcomes (3)

• Parent Functioning

  Baseline, Week 10, Week 20

• Interfering Behaviors at Mealtime

  Baseline, Week 10, Week 20

• Healthy Eating Index

  Baseline, Week 10, Week 20

Study Arms (2)

Parent Training Program (PT-F)

EXPERIMENTAL

Treatment group

Behavioral: Parent Training Program

Waitlist

NO INTERVENTION

Control group in which parents randomized to this group will be offered the PT-F at the end of the 20 week study period to address their child's feeding issues.

Interventions

Parent Training Program BEHAVIORAL

An 11-session manualized behavioral parent training program for the treatment of feeding problems teaching parents to use a range of behavioral procedures to address a variety of common feeding problems.

Also known as: PT-F

Parent Training Program (PT-F)

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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). \[Rationale: Many children with ASD are on medications to target associated behaviors. These include stimulants and atypical antipsychotics. Excluding these children could result in a non-representative sample of children with ASD and feeding problems. We will require that the feeding problems pre-date the initiation of medications / supplements\].

You may not qualify if:

• 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. \[Rationale: Parents will need sufficient command of English to benefit from the English materials\].

Sponsors & Collaborators

• University of Florida: lead
• University of Rochester: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Cynthia R Johnson, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 27, 2014
• Study Start: February 1, 2015
• Primary Completion: January 25, 2017
• Study Completion: June 25, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (2)