Treatment of Feeding Problems in Children With Autism

NCT ID: NCT02275715

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-06-25

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.

Conditions

Treatment of Feeding Problems in Children With ASD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Parent Training Program (PT-F)

Treatment group

Group Type: EXPERIMENTAL

Parent Training Program

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PT-F

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].

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia R Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

IRB201400831-N

Identifier Type: -

Identifier Source: org_study_id