Clinical trial NCT03138551: Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions
Official title: Examining Relationships Between Family Mealtime Routines and Feeding Outcomes in Young Children With Sensory Food Aversions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Disorder of Infancy or Early Childhood
Keywords: Sensory Food Aversions
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Single-Case Experimental Design
Primary purpose: TREATMENT

Brief summary: 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.

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parent-training (while parents are practicing skills learned), and following parent training (when therapist support is withdrawn).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.

Eligibility criteria: 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

Primary outcomes:
measure: Food Acceptance
timeFrame: 30 meals video recorded throughout study participation (10 per phase, 1 month)
Secondary outcomes:
measure: 3-Day Food Diary
timeFrame: Baseline through Study Completion (1 month)
measure: Behavioral Pediatric Feeding Assessment (BPFAS)
timeFrame: Baseline through Study Completion (1 month)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Angela R Caldwell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.