Pediatric Feeding DisordersPhase 4NCT02187952
Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children
A Phase 4 study testing Behavioral feeding intervention in people with Pediatric Feeding Disorders, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 48 months
- Conditions the study is for
- Pediatric Feeding Disorders
- What is being tested?
- Behavioral feeding intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- Clinically significant feeding problem
- Self-initiates movement
- Can be left alone in a room for 3 minutes
- Capable of initiating eye contact
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pediatric Feeding Disorders
- Being tested
- Behavioral feeding intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral feeding interventionBehavioural
Behavioral feeding intervention will include escape extinction.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral feeding intervention | Experimental | Behavioral feeding intervention will be conducted as usual. The intervention will not be altered for purposes of the study. Receives: Behavioral: Behavioral feeding intervention |
| Waitlist control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment, 6 months, 1 year
Secondary outcomes (4)
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.
Measured: Enrollment, 6 months, 1 year
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.
Measured: Enrollment, 6 months, 1 year
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.
Measured: Enrollment, 6 months, 1 year
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.
Measured: Enrollment, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Feeding DisordersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, Amy K. Drayton, University of Michigan
- Investigators
- Amy K Drayton, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187952
- Sponsor's protocol ID
- 13-PAF07294
- Status last verified
- Apr 2016
- First submitted
- 2 Jul 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children
- ClinicalTrials.gov ID
- NCT02187952
- Acronym / sponsor ID
- 13-PAF07294
- Conditions
- Pediatric Feeding Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral feeding intervention | Experimental | Behavioral: Behavioral feeding interventionBehavioral feeding intervention will be conducted as usual. The intervention will not be altered for purposes of the study. |
| Waitlist control | No intervention | – |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Caregiver Based
- Mothers
- Conducts feeding intervention ≥75% of the time at home
- Understands and speaks English
- Child Based
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral feeding interventionBehavioral feeding intervention will include escape extinction. | Behavioural | Behavioral feeding intervention |
Primary outcome
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.
4 secondary outcomes
Change in infant social and emotional behavior
Time frame: Enrollment, 6 months, 1 year
Change in child externalizing and internalizing behavior.
Time frame: Enrollment, 6 months, 1 year
Change in maternal behavior when interacting with her child
Time frame: Enrollment, 6 months, 1 year
Change in child feeding behavior.
Time frame: Enrollment, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy K Drayton, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Behavioral feeding intervention in people with Pediatric Feeding Disorders, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in attachment status (time frame: Enrollment, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.