Infant Peer Interaction Study by Examining the Effect of a 6-week Music Enhancement Program

NCT04289168 | Completed

• 1 other identifier: Infant PIS
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall purpose of this study is to better understand food reinforcement in infants. The results of this study should help to further our understanding of how individuals relate to food and how an enriched environment can change this behavior.

Conditions

Body Weight Changes

Outcome Measures

Primary Outcomes (1)

• The primary study outcome is the food reinforcing ratio (FRR)

  Infant completed the pre- and post-intervention's FRR task in the lab

  through study completion, an average 13 months

Secondary Outcomes (3)

• Infant weight

  through study completion, an average 13 months

• Infant height

  through study completion, on average 13 months

• Infant zWFL

  through study completion, on average 13 months

Study Arms (2)

Music Class

EXPERIMENTAL

Music Class attendance

Behavioral: Music

Play Class

NO INTERVENTION

Play date class attendance

Interventions

Music BEHAVIORAL

Music class was provided for the intervention group

Music Class

Eligibility Criteria

• Age: 9 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy
• single birth
• between 9-18 months
• not allergic to puffed grains or cheerios

You may not qualify if:

• Your child was premature/preterm at birth (\< 37 weeks of gestation)
• Your child had a low birth weight (\<2500 grams)
• Your child had any medical problems at birth
• Your child showed signs of developmental delay based on his/her developmental milestones recorded when he/she was 6 to 9 months old
• Infant who are currently participating or previously participated in Music Together® program or similar music program
• Maternal age was less than 18 years at the time of your child's birth
• Mother smoked, used controlled substances (i.e. opiates, cocaine, marijuana) or consumed excessive alcohol during pregnancy
• Mother had a high-risk pregnancy
• Infant who could not complete a food/social interaction reward task during the further screening/pre-intervention assessment
• Your child is not overweight

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• research institute on addictions: collaborator

MeSH Terms

Conditions

Body Weight Changes

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kai ling Kong

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: February 18, 2020
• First Posted: February 28, 2020
• Study Start: August 11, 2014
• Primary Completion: June 30, 2015
• Study Completion: August 30, 2015
• Last Updated: October 20, 2020

Record last verified: 2020-10