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

NCT ID: NCT03138551

Last Updated: 2019-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-11

Study Completion Date

2018-10-01

Brief Summary

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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

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(while parents are practicing skills learned), and following parent training (when therapist support is withdrawn).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

Conditions

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Feeding Disorder of Infancy or Early Childhood

Study Design

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Intervention Model

SEQUENTIAL

Single-Case Experimental Design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 Therapist support withdrawn.

Group Type EXPERIMENTAL

Mealtime PREP (Promoting Routines of Exploration and Play)

Intervention Type BEHAVIORAL

Interventions

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Mealtime PREP (Promoting Routines of Exploration and Play)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Angela Caldwell

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela R Caldwell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30760395 (View on PubMed)

Other Identifiers

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PRO15060533

Identifier Type: -

Identifier Source: org_study_id

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