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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

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

Clinicaltrials.gov identifier NCT02187952

Recruitment Status Completed

First Posted July 11, 2014

Last update posted April 14, 2016

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.

  • Condition or Disease:Pediatric Feeding Disorders
  • Intervention/Treatment: Behavioral: Behavioral feeding intervention
  • Phase: Phase 4
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 24 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children
  • Study Start Date: July 2014
  • Actual Primary Completion Date: February 2016
  • Actual Study Completion Date: February 2016
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 12 to 48 Months (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

United States, Michigan
University of Michigan
Ann Arbor

Sponsors and Collaborators

University of Michigan

The Gerber Foundation

Investigators

Principal Investigator: Amy K Drayton, PhD University of Michigan

More Information
  • Responsible Party: University of Michigan
  • ClinicalTrials.gov Identifier: NCT02187952 History of Changes
  • Other Study ID Numbers: 13-PAF07294
  • First Posted: July 11, 2014 Key Record Dates
  • Last Update Posted: April 14, 2016
  • Last Verified: April 2016
  • Additional relevant MeSH terms: Feeding and Eating Disorders