Language Development, Obesity, Infant, Parent-Child Relations
Conditions
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: 1. be video recorded during 10 minutes of playtime and meal time. 2. fill out questionnaires 3. wear a small wearable language recorder for 16 hours 3. 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: 1. Play a computer game to test motivation for food 2. 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.
Interventions
BEHAVIORALMusic 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.
BEHAVIORALPlay 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.
Sponsors
University of Kansas Medical Center
University of Kansas
National Center for Advancing Translational Sciences (NCATS)
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Months to 24 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Music at Home | Baseline and Post (16 weeks) | The Music @ Home Questionnaire was used to quantitatively assess the range of musical behaviors occurring in the home environment of families with young children. Participant score is based on a questionnaire with 18 questions each with a range of 1-7. Total score range of the questionnaire is 7- 126. The higher outcome is better. |
| Conversational Turns | Baseline, Mid (8 weeks), Post (16 weeks) | Back-and-forth vocalizations between a parent and child, even with pre-linguistic children, are considered a pivotal component of a high-quality early language environment because they associate with growth in specific brain regions responsible for language and cognitive development. |
| Relative Reinforcing Value of Food (RRV) Task | Baseline, Mid (8 weeks), Post (16 weeks) | RRVfood is a proximal measure of obesity risk. It measures how motivated one is to work to gain access to food versus non-food activity. RRVfood is the score for food divided by the total score (food + music). Scale range is 0-1. Lower number is the better outcome. The score for food is determined by a computer game to test motivation for food. The score for music is determined by a computer game to test motivation for music. |
Countries
United States
Participant flow
Recruitment details
The Protocol Enrollment represents the total number of dyads enrolled.
Pre-assignment details
4 participants dropped out after enrollment before group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Music Together-child Music Together-child: 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. | 8 |
| Play Group-child Play Group-child: 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. | 8 |
| Music Together-parent Music Together-parent: 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. | 8 |
| Play Group-parent Play Group-parent: 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. | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | Music Together-child | Play Group-child | Music Together-parent | Play Group-parent | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 8 Participants | 0 Participants | 0 Participants | 16 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 8 Participants | 8 Participants | 16 Participants |
| Age, Continuous | 1.32 years STANDARD_DEVIATION 0.4 | 1.43 years STANDARD_DEVIATION 0.39 | 30.43 years STANDARD_DEVIATION 5.02 | 33.25 years STANDARD_DEVIATION 5.06 | 16.61 years STANDARD_DEVIATION 2.72 |
| Conversational turns | 280.19 count STANDARD_DEVIATION 69.99 | 216.07 count STANDARD_DEVIATION 74.82 | — | — | 248.13 count STANDARD_DEVIATION 72.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 8 Participants | 7 Participants | 8 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 3 Participants | 6 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 0 Participants | 4 Participants | 1 Participants | 8 Participants |
| Region of Enrollment United States | 8 participants | 8 participants | 8 participants | 8 participants | 16 participants |
| Relative reinforcing value of food (RRVfood) | 0.50 units on a scale STANDARD_DEVIATION 0.06 | 0.40 units on a scale STANDARD_DEVIATION 0.06 | — | — | 0.45 units on a scale STANDARD_DEVIATION 0.06 |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants | 8 Participants | 24 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 0 Participants | 0 Participants | 8 Participants |
| Use of music at home | 94.87 units on a scale STANDARD_DEVIATION 7.25 | 98.83 units on a scale STANDARD_DEVIATION 8.26 | — | — | 96.85 units on a scale STANDARD_DEVIATION 7.76 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Conversational Turns
Back-and-forth vocalizations between a parent and child, even with pre-linguistic children, are considered a pivotal component of a high-quality early language environment because they associate with growth in specific brain regions responsible for language and cognitive development.
Time frame: Baseline, Mid (8 weeks), Post (16 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Together Baseline | Conversational Turns | 8392.67 count | Standard Error 1625.78 |
| Play Group Baseline | Conversational Turns | 13535.00 count | Standard Error 1407.96 |
| Music Together Mid | Conversational Turns | 6116.33 count | Standard Error 1867 |
| Play Group Mid | Conversational Turns | 13410.88 count | Standard Error 1616.87 |
| Music Together Post | Conversational Turns | 9974.50 count | Standard Error 4227.72 |
| Play Group Post | Conversational Turns | 10913.88 count | Standard Error 3661.32 |
Primary
Relative Reinforcing Value of Food (RRV) Task
RRVfood is a proximal measure of obesity risk. It measures how motivated one is to work to gain access to food versus non-food activity. RRVfood is the score for food divided by the total score (food + music). Scale range is 0-1. Lower number is the better outcome. The score for food is determined by a computer game to test motivation for food. The score for music is determined by a computer game to test motivation for music.
Time frame: Baseline, Mid (8 weeks), Post (16 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Together Baseline | Relative Reinforcing Value of Food (RRV) Task | 0.48 units on a scale | Standard Error 0.08 |
| Play Group Baseline | Relative Reinforcing Value of Food (RRV) Task | 0.35 units on a scale | Standard Error 0.08 |
| Music Together Mid | Relative Reinforcing Value of Food (RRV) Task | 0.5 units on a scale | Standard Error 0.07 |
| Play Group Mid | Relative Reinforcing Value of Food (RRV) Task | 0.4 units on a scale | Standard Error 0.07 |
| Music Together Post | Relative Reinforcing Value of Food (RRV) Task | 0.53 units on a scale | Standard Error 0.08 |
| Play Group Post | Relative Reinforcing Value of Food (RRV) Task | 0.62 units on a scale | Standard Error 0.08 |
Primary
Use of Music at Home
The Music @ Home Questionnaire was used to quantitatively assess the range of musical behaviors occurring in the home environment of families with young children. Participant score is based on a questionnaire with 18 questions each with a range of 1-7. Total score range of the questionnaire is 7- 126. The higher outcome is better.
Time frame: Baseline and Post (16 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music Together Baseline | Use of Music at Home | 95 units on a scale | Standard Error 14 |
| Play Group Baseline | Use of Music at Home | 100.5 units on a scale | Standard Error 12.13 |
| Music Together Mid | Use of Music at Home | 106.33 units on a scale | Standard Error 11.33 |
| Play Group Mid | Use of Music at Home | 98.25 units on a scale | Standard Error 9.81 |