Treatment of Feeding Problems in Children With Autism (PT-F)

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.

Study Overview

• Status: Completed
• Conditions: Treatment of Feeding Problems in Children With ASD
• Intervention / Treatment: Behavioral: Parent Training Program

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
  • New York
    • Rochester, New York, United States, 14627
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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].

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parent Training Program (PT-F); Treatment group	Behavioral: Parent Training Program; 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.; Other Names: PT-F
No Intervention: Waitlist; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Autism Mealtime Behavior Inventory (BAMBI)	Measure of mealtime behavior problems	Baseline, Week 10, Week 20

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Functioning	Measure of parent reported stress, competency, and parent-child interactions at mealtime as rated by the Parenting Stress Index, Caregiver Strain Questionnaire, Parenting Sense Of Competence, and About Your Child's Eating	Baseline, Week 10, Week 20
Interfering Behaviors at Mealtime	Measure of repetitive behaviors, sensory sensitivities, tantrum, irritability, and noncompliance as rated by the Repetitive Behaviors Scales - Revised, Short Sensory Profile, Aberrant Behavior Checklist, and Home Situations Questionnaire	Baseline, Week 10, Week 20
Healthy Eating Index	Measure of nutritional intake	Baseline, Week 10, Week 20

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Mental Health (NIMH); University of Rochester
• Investigators: Principal Investigator: Cynthia R Johnson, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 25, 2017
• Study Completion (Actual): June 25, 2017

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 22, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: autism spectrum disorder (ASD); feeding problems
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: IRB201400831-N