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

April 12, 2016 updated by: Amy K. Drayton, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral feeding intervention
Behavioral feeding intervention will be conducted as usual. The intervention will not be altered for purposes of the study.
Behavioral: Behavioral feeding intervention
Behavioral feeding intervention will include escape extinction.
No Intervention: Waitlist control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in attachment status
Time Frame: Enrollment, 6 months, 1 year
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.
Enrollment, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in infant social and emotional behavior
Time Frame: Enrollment, 6 months, 1 year
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.
Enrollment, 6 months, 1 year
Change in child externalizing and internalizing behavior.
Time Frame: Enrollment, 6 months, 1 year
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.
Enrollment, 6 months, 1 year
Change in maternal behavior when interacting with her child
Time Frame: Enrollment, 6 months, 1 year
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.
Enrollment, 6 months, 1 year
Change in child feeding behavior.
Time Frame: Enrollment, 6 months, 1 year
The Behavioral Pediatrics Feeding Assessment Scale (BPFAS) will be used to measure any changes in the feeding behavior of children.
Enrollment, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

The Gerber Foundation

Investigators

  • Principal Investigator: Amy K Drayton, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-PAF07294

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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