Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 14, 2016
April 1, 2016
1.6 years
July 2, 2014
April 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Enrollment, 6 months, 1 year
Secondary Outcomes (4)
Change in infant social and emotional behavior
Enrollment, 6 months, 1 year
Change in child externalizing and internalizing behavior.
Enrollment, 6 months, 1 year
Change in maternal behavior when interacting with her child
Enrollment, 6 months, 1 year
Change in child feeding behavior.
Enrollment, 6 months, 1 year
Study Arms (2)
Behavioral feeding intervention
EXPERIMENTALBehavioral feeding intervention will be conducted as usual. The intervention will not be altered for purposes of the study.
Waitlist control
NO INTERVENTIONInterventions
Behavioral feeding intervention will include escape extinction.
Eligibility Criteria
You may qualify if:
- Caregiver Based
- Mothers
- Conducts feeding intervention ≥75% of the time at home
- Understands and speaks English
- Child Based
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- The Gerber Foundationcollaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Amy K Drayton, PhD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 11, 2014
Study Start
July 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 14, 2016
Record last verified: 2016-04