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Completed

NCT Number: NCT02187952

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

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.

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Key information

Conditions

Pediatric Feeding Disorders

Age range

12 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral feeding intervention

Behavioral

Behavioral feeding intervention will include escape extinction.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • The Gerber Foundation

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2014
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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