Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions

Examining Relationships Between Family Mealtime Routines and Feeding Outcomes in Young Children With Sensory Food Aversions

This study will examine the feasibility and preliminary effects of the Mealtime PREP (Promoting Routines of Exploration and Play) intervention package for young children with Sensory Food Aversions and their parents.

Study Overview

• Status: Completed
• Conditions: Feeding Disorder of Infancy or Early Childhood
• Intervention / Treatment: Behavioral: Mealtime PREP (Promoting Routines of Exploration and Play)

Detailed Description

This pilot study will collect rich data from twenty participants on the feasibility and effects of a novel intervention, the Mealtime PREP, which has a dyadic focus on both the young child and the parent participants. The investigators will collect video recorded child meals in the home during a baseline period (under normal circumstances), during parent-training (while parents are practicing skills learned), and following parent training (when therapist support is withdrawn). This in depth examination of child meals will provide valuable information to guide the optimization of this intervention approach for future trials.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Child must meet all criteria of the diagnosis of Sensory Food Aversions

  1. The child consistently refuses to eat specific foods with specific tastes/textures and/or smells.
  2. Onset of food refusal occurs during the introduction of a novel type of food (e.g., the child may drink one type of milk but refuse another, may eat carrots but refuse green beans, may drink milk but refuse baby food).
  3. The child eats without difficulty when offered preferred foods.
  4. The food refusal causes specific nutritional deficiencies or delay of oral motor development.
• Parent is able to read, write, speak and understand English.

Exclusion Criteria: None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mealtime PREP; Every participant enrolled in this single-case experimental design trial with multiple replications progressed through three phases. A: Baseline - typical mealtimes in the home. B: Parent-Training - parents trained in Mealtime PREP (Promoting Routines of Exploration and Play) intervention. B-prime: Family Autonomy - parents continue to deliver treatment strategies. Therapist support withdrawn.

Behavioral: Mealtime PREP (Promoting Routines of Exploration and Play)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Acceptance	Significant change in percentage of targeted food accepted between phases.	30 meals video recorded throughout study participation (10 per phase, 1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-Day Food Diary	Increased number of foods eaten over a three-day period.	Baseline through Study Completion (1 month)
Behavioral Pediatric Feeding Assessment (BPFAS)	Clinically relevant change in child feeding behavior and/or parental report of mealtime problems.	Baseline through Study Completion (1 month)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Angela R Caldwell, PhD, University of Pittsburgh

Publications and helpful links

General Publications

• Caldwell AR, Skidmore ER, Raina KD, Rogers JC, Terhorst L, Danford CA, Bendixen RM. Behavioral Activation Approach to Parent Training: Feasibility of Promoting Routines of Exploration and Play During Mealtime (Mealtime PREP). Am J Occup Ther. 2018 Nov/Dec;72(6):7206205030p1-7206205030p8. doi: 10.5014/ajot.2018.028365.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Sensory Food Aversions
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: PRO15060533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no plan to make individual participant data available to other researchers.