Technology-supported Behavioral Feeding Intervention

NCT02119910 | Completed

• 1 other identifier: IRB00072609
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation proposes to examine the effectiveness of a technology supported treatment manual for pediatric feeding disorders. Children with pediatric feeding disorders display intense avoidance behaviors (e.g., crying, tantrums, and disruptions) that prevent appropriate nutritional intake during meals and lead to a number of negative and potentially life threatening medical outcomes, including chronic malnutrition, growth retardation, and placement of a feeding tube. To date, behavioral intervention involving extinction-based procedures represents the only treatment for pediatric feeding disorders supported by research to improve mealtime behaviors. Due to the chronic and extreme nature of food refusal, treatment typically requires intensive, daily intervention conducted at highly specialized clinics to improve feeding behaviors. The cost and duration of intervention can total as much as $60,000 per child requiring up to 6 to 8 weeks, respectively. The potential for serious consequences associated with chronic food refusal, combined with the high cost of treatment, intensifies the need to identify means to disseminate effective treatment approaches to the broader community of healthcare providers. The proposed study represents the first attempt to systematically investigate the use of a treatment manual to address chronic food aversion through a randomized, waitlist control trial in children treated at the Marcus Autism Center's Pediatrics Feeding Disorders Program. This study will involve a total of 20 participants randomly assigned to experimental conditions: technology supported treatment manual or waitlist control group (10 in each group). Children assigned to the waitlist control group will receive the technology supported treatment manual after the specified time on the waitlist. All participants will receive the same behavioral protocol involving three treatment sessions per day (45 minutes in length), for a total of 15 sessions across five consecutive days. Data will be collected on feeding behaviors during each treatment session and at follow-up using trained observers to collect data on mealtime behaviors, including acceptance, swallowing, disruption, expulsion, and grams consumed. This type of data collection and treatment is standard practice in the feeding disorders program; however, the use of a touch screen application for data capture with integrated manual is novel to this project.

Conditions

Feeding and Eating Disorders of Childhood

Keywords

pediatric feeding disorders; behavioral intervention; treatment manual; feeding; food refusal; diet

Outcome Measures

Primary Outcomes (1)

• Mealtime Behaviors

  Behavioral ratings will document such variables as acceptance, mouth clean, combined inappropriate behavior, expulsions, and grams consumed. Data on each of these variables will be collected on computers using an event-recording program built into the computerized manual. Acceptance will be scored when a child takes one or more bites independently every 30 seconds or allows the entire bite of food to be deposited in his/her mouth within 5 seconds of the initial presentation. A mouth clean will be scored when the child swallows all the food within 30 seconds. Data will also be collected on combined inappropriate mealtime behaviors, which are defined as head turns and disruptions. Expulsions will be defined as the presence of food greater than the size of a pea visible outside the mouth after the bite enters the child's mouth.

  1 week

Secondary Outcomes (1)

• Parenting Stress Index- Short Form

  1 month

Study Arms (2)

Technology Supported Manual

EXPERIMENTAL

Participants in this arm will receive behavioral intervention for a period of 5 consecutive days. A total of 3, 45-minute meals will be held at regularly scheduled times (e.g., 9:00 a.m., 10:30 a.m., and 12:00 p.m.) each day for a total of 15 meals throughout treatment.

Behavioral: Technology Supported Manual

Waitlist

NO INTERVENTION

Participants will serve as the control condition.

Interventions

Technology Supported Manual BEHAVIORAL

Technology Supported Manual

Eligibility Criteria

• Age: 12 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• The following will be considered ineligible to participate in the study: 1) Patients with active medical diagnoses requiring hospitalization or significant oversight from a physician; and 2) Patients with active medical, structural, or functional limitations preventing safe oral intake of pureed foods (e.g., aspiration, upper airway obstruction).

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

The Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders of Childhood

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 22, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

US (1)