Treatment of Feeding Problems in Children With Autism (PT-F)
Primary Purpose
Treatment of Feeding Problems in Children With ASD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Training Program
Sponsored by
About this trial
This is an interventional treatment trial for Treatment of Feeding Problems in Children With ASD focused on measuring autism spectrum disorder (ASD), feeding problems
Eligibility Criteria
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].
Sites / Locations
- University of Florida
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Parent Training Program (PT-F)
Waitlist
Arm Description
Treatment group
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.
Outcomes
Primary Outcome Measures
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.
Treatment Fidelity
Measure of therapists' ability to deliver PT-F with > 80% average fidelity as rated by fidelity checklists
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.
Secondary Outcome Measures
Brief Autism Mealtime Behavior Inventory (BAMBI)
Measure of mealtime behavior problems
Full Information
NCT ID
NCT02275715
First Posted
October 15, 2014
Last Updated
April 4, 2018
Sponsor
University of Florida
Collaborators
University of Rochester, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02275715
Brief Title
Treatment of Feeding Problems in Children With Autism
Acronym
PT-F
Official Title
Treatment of Feeding Problems in Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 25, 2017 (Actual)
Study Completion Date
June 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
University of Rochester, National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Feeding Problems in Children With ASD
Keywords
autism spectrum disorder (ASD), feeding problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parent Training Program (PT-F)
Arm Type
Experimental
Arm Description
Treatment group
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent Training Program
Other Intervention Name(s)
PT-F
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects with Complete Data
Description
Measure of feasibility of randomized controlled trial by successful recruitment of 50 subjects with complete data collected from > 80% (> 40) subjects.
Time Frame
Week 20
Title
Treatment Fidelity
Description
Measure of therapists' ability to deliver PT-F with > 80% average fidelity as rated by fidelity checklists
Time Frame
Week 20
Title
Parent Adherence
Description
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.
Time Frame
Week 20
Secondary Outcome Measure Information:
Title
Brief Autism Mealtime Behavior Inventory (BAMBI)
Description
Measure of mealtime behavior problems
Time Frame
Baseline, Week 10, Week 20
Other Pre-specified Outcome Measures:
Title
Parent Functioning
Description
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
Time Frame
Baseline, Week 10, Week 20
Title
Interfering Behaviors at Mealtime
Description
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
Time Frame
Baseline, Week 10, Week 20
Title
Healthy Eating Index
Description
Measure of nutritional intake
Time Frame
Baseline, Week 10, Week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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].
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia R Johnson, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
12. IPD Sharing Statement
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Treatment of Feeding Problems in Children With Autism
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