Music and Child Health and Development

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05868811
Collaborator
University of Kansas Medical Center (Other), Jackson County Missouri (Other)
80
1
2
19.5
4.1

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to learn about the effects of a music enrichment program on the quality of parent child interactions, a child's motivation to eat, and a child's language environment in 9 to 24 month-old children from low-income families. The main questions it aims to answer are:

  1. Does participation in a music enrichment program improve the quality of parent-child interactions?

  2. Does participation in a music enrichment program reduce motivation for food

  3. Does participation in a music enrichment program improve the quality of the language environment?

Participants will:
  1. Be randomly assigned to participate in either 2, 8-week semesters of weekly music enrichment classes or play group sessions.

  2. At the beginning, after the first 8 weeks and after the second 8 weeks, a researcher will come to the participants house and parent-child pairs will:

  3. be video recorded during 10 minutes of playtime and meal time.

  4. fill out questionnaires

  5. wear a small wearable language recorder for 16 hours

  6. At the beginning, after the first 8 weeks and after the second 8 weeks, the parent and child will come to the baby lab and will:

  7. Play a computer game to test motivation for food

  8. have height and weight measurements collected

Researchers will compare the music and play groups to see if there is a difference in the quality of parent child interaction, food motivation or language environment.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music Together
  • Behavioral: Play Group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Feasibility Study of Music and Play to Enhance Health and Developmental Outcomes in Infants From Low-income Families
Actual Study Start Date :
Jan 16, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music Together

Behavioral: Music Together
The intervention consists of 45-minute weekly classes for 16 weeks. Each class is delivered by a trained Music Together facilitator and includes music activities such as singing, dancing, moving and playing musical instruments. At the start of the program, participants receive materials for home use that consist of a song book and online access code for song recordings used in the class.

Placebo Comparator: Play Group

Behavioral: Play Group
The play group consists of 45-minute weekly classes for 16 weeks. During each class parents are encouraged to play with their child and interact with other participants using the provided age appropriate toys. At the start of the program participants receive an age appropriate toy for use at home.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline infant food reinforcing ratio at 8 weeks and 16 weeks [Baseline, 8-weeks, 16-weeks]

    Infant will potentially change their food reinforcing ratio (FRR) based on the randomized class. Name of the measurement: Food reinforcing ratio (FRR) Unit of measure: ratio

  2. Change from Baseline conversational turns at 8 weeks and 16 weeks [Baseline, 8-weeks, 16-weeks]

    Parent-child dyads will potentially change their frequency of conversational turns based on the randomized class. Name of measurement: Conversational turns Unit of measure: frequency count

  3. Change from Baseline Quality of parent-child interactions at 8-weeks and 16-weeks [Baseline, after semester 1, after semester 2]

    Parent-child dyads will potentially change their quality of interactions based on the randomized class. Name of measurement: The parent child early relational assessment (PCERA) Unit of measure: 5-point global rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Months to 24 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Family income meets criteria for the National Women, Infant, and Children (WIC) program

  • Family is able and willing to commit to a 6-month program

Exclusion Criteria:
  • Mother <18 years old at the time of delivery

  • During pregnancy:

  • Mother smoked >10 cigarettes/day

  • Mother used >1 marijuana joint/day

  • Mother used any other illicit drugs

  • Mother drank > 3 standard drinks on a single occasion or >1 standard drink on a daily basis

  • Preterm birth <37 weeks gestation

  • Child with significant health issues, and/or genetic conditions (e.g., cerebral palsy, down's syndrome)

  • Mother with major health concerns during pregnancy (e.g., gestational diabetes, pre-eclampsia, etc)

  • Parent/child who do not speak English

Contacts and Locations

Locations

Site City State Country Postal Code
1 ChildrensMHC Kansas City Missouri United States 64108

Sponsors and Collaborators

  • Children's Mercy Hospital Kansas City
  • University of Kansas Medical Center
  • Jackson County Missouri

Investigators

  • Principal Investigator: Kai Ling Kong, PhD, Children's Mercy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kai Ling Kong, Doctoral Research Faculty, PhD, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT05868811
Other Study ID Numbers:
  • STUDY00002451
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2023