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Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children

Primary Purpose

Pediatric Feeding Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Behavioral feeding intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Feeding Disorders

Eligibility Criteria

12 Months - 48 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Caregiver Based

  • Mothers
  • Conducts feeding intervention ≥75% of the time at home
  • Understands and speaks English

Child Based

  • 12-14 or 30-48 months old at initial assessment
  • Clinically significant feeding problem
  • Self-initiates movement
  • Can be left alone in a room for 3 minutes
  • Capable of initiating eye contact

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral feeding intervention

Waitlist control

Arm Description

Behavioral feeding intervention will be conducted as usual. The intervention will not be altered for purposes of the study.

Outcomes

Primary Outcome Measures

Change in attachment status
The Strange Situation (SS) will be used to assess any changes in mother-child attachment status. The SS consists of a series of separations and reunions between a mother and her child.

Secondary Outcome Measures

Change in infant social and emotional behavior
Brief Infant Toddler Social Emotional Assessment (BITSEA) will be used to assess any changes in the social and emotional behavior of children who are 12-36 months of age.
Change in child externalizing and internalizing behavior.
The Child Behavior Checklist will be used to assess any changes in the internalizing and externalizing behavior of children who are 1.5 to 5 years of age.
Change in maternal behavior when interacting with her child
Mother-child dyads will be given toys and asked to play as they normally would for 10 minutes. The purpose of this measure is to detect any changes in parent-child interaction patterns that may be more sensitive to short-term intervention than attachment status.
Change in child feeding behavior.
The Behavioral Pediatrics Feeding Assessment Scale (BPFAS) will be used to measure any changes in the feeding behavior of children.

Full Information

First Posted
July 2, 2014
Last Updated
April 12, 2016
Sponsor
University of Michigan
Collaborators
The Gerber Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02187952
Brief Title
Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children
Official Title
Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
The Gerber Foundation

4. Oversight

5. Study Description

Brief Summary
The primary objective of the proposed study is to determine whether behavioral feeding intervention impacts mother-child attachment in infants and toddlers with feeding problems. The investigators propose the following hypotheses: Behavioral feeding intervention will not significantly impact parent-child attachment. Behavioral feeding intervention will not significantly impact parent-child unstructured play interactions. Severity of feeding problems will decrease after behavioral feeding intervention is implemented. Behavioral feeding intervention will have either no significant effect or a significant positive effect on general child behavior.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Feeding Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral feeding intervention
Arm Type
Experimental
Arm Description
Behavioral feeding intervention will be conducted as usual. The intervention will not be altered for purposes of the study.
Arm Title
Waitlist control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Behavioral feeding intervention
Intervention Description
Behavioral feeding intervention will include escape extinction.
Primary Outcome Measure Information:
Title
Change in attachment status
Description
The Strange Situation (SS) will be used to assess any changes in mother-child attachment status. The SS consists of a series of separations and reunions between a mother and her child.
Time Frame
Enrollment, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Change in infant social and emotional behavior
Description
Brief Infant Toddler Social Emotional Assessment (BITSEA) will be used to assess any changes in the social and emotional behavior of children who are 12-36 months of age.
Time Frame
Enrollment, 6 months, 1 year
Title
Change in child externalizing and internalizing behavior.
Description
The Child Behavior Checklist will be used to assess any changes in the internalizing and externalizing behavior of children who are 1.5 to 5 years of age.
Time Frame
Enrollment, 6 months, 1 year
Title
Change in maternal behavior when interacting with her child
Description
Mother-child dyads will be given toys and asked to play as they normally would for 10 minutes. The purpose of this measure is to detect any changes in parent-child interaction patterns that may be more sensitive to short-term intervention than attachment status.
Time Frame
Enrollment, 6 months, 1 year
Title
Change in child feeding behavior.
Description
The Behavioral Pediatrics Feeding Assessment Scale (BPFAS) will be used to measure any changes in the feeding behavior of children.
Time Frame
Enrollment, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Caregiver Based Mothers Conducts feeding intervention ≥75% of the time at home Understands and speaks English Child Based 12-14 or 30-48 months old at initial assessment Clinically significant feeding problem Self-initiates movement Can be left alone in a room for 3 minutes Capable of initiating eye contact
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy K Drayton, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children

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