The Synchrony Study: Examining Music Training for Children With FASD (Synchrony)

March 12, 2024 updated by: Julia Stephen, The Mind Research Network

The Synchrony Study: A Randomized Controlled Trial of Music Training for Children With a Fetal Alcohol Spectrum Disorder (FASD)

The goal of this clinical trial is to examine if music training improves behavioral or cognitive performance in children with prenatal alcohol exposure who meet research criteria for a fetal alcohol spectrum disorder. The main questions it aims to answer are:

  • Does music training improve behavioral regulation for children with an FASD
  • Does music training improve cognitive performance (attention and working memory) for children with an FASD.

The study has two interventions for each participant: music listening and piano training. Each participant will either practice piano daily for 12 weeks or listen to pre-selected music daily for 12 weeks. The order of the interventions will be randomized across participants. Assessment will occur before and after participation in each 12 week intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Music training has been shown to alter brain function and structure in musicians relative to nonmusicians. Music training requires a complex set of skills. By engaging in this activity, music training may alter brain development in children and increase cortical connectivity such that it provides improved self-regulation and cognitive performance. However, music training has not been tested in children with a fetal alcohol spectrum disorder, despite known behavioral and cognitive effects of prenatal alcohol exposure.

The study will employ a randomized, cross-over design to examine the effects of piano training versus music listening. Participants will be asked to attend two information sessions prior to study enrollment. These will provide participants with detailed information about the study expectations, complete study consent/assent, and train participants on use of the devices for music listening/piano training. Participants will receive baseline assessments which include cognitive testing, behavioral questionnaires and neuroimaging. Each participant will be randomized to receive 12 weeks of either music listening or piano training. After the initial 12 week intervention is completed, participants will receive an intermediate assessment where the initial assessment battery will be repeated. The participants will then engage in the other arm of the study (music listening or piano training) for an additional 12 weeks. During the last week of the study, the initial assessment battery will be repeated a third time.

During music listening, the participant will be provided with a device that will allow the participant to access study-selected music. Participants will be provided with one music list/week for 12 weeks and will be asked to listen to music from the study-selected music for at least 10 minutes per day. Participants will be required to check in with the study team weekly to receive the next week's playlist and to ensure compliance.

During piano training, the participant will be provided with an electronic keyboard that will allow the participant to practice piano daily. Participants will attend weekly ½ hour piano lessons which will follow a commercially-available beginner piano curriculum. Participants will be assigned weekly homework with the requirement of practicing piano at least 10 minutes per day. Progress will be checked at each weekly piano lesson to ensure compliance.

All data will be either collected directly from the participants using COINS, an online database and assessment tool, or will be double data entered into COINS with conflicts resolved through consultation of the source material. Assessments will be transferred to the National Institute on Alcohol Abuse and Alcoholism data archive (NIAAA-DA), which validates data entry values relative to expected ranges. Any violations will be corrected within the COINS database via consultation with source material and re-extracted for data upload to NIAAA-DA. NIAAA-DA will maintain the source material. Missing data will be examined for any systematic pattern of missingness. Mixed effects models are relatively insensitive to missing data. If necessary, missing data will be replaced using standard statistical methods.

Standard statistical analysis approaches will be employed to evaluate the data for violation of assumptions of the statistical models. Transformations will be performed as necessary. Outcome variables will be compared statistically between the music listening and piano training arms using repeated measures analysis of variance (or covariance) or mixed effects models depending on the amount of missing data. Working memory will be assessed using the Wechsler Intelligence Scale for Children (WISC) Digit span and picture span subtests. Attention will be assessed using the Conners Continuous Performance Test 3 (CPT3). Behavioral regulation will be assessed using the Behavioral Rating Inventory of Executive Function 2 (BRIEF2). Age, socioeconomic status, and music experience will be included as covariates in the model, as needed. Sex effects on outcome variables will also be examined.

H1: Piano training will produce improvements in behavioral regulation (BRIEF2) relative to music listening.

H2: Piano training will produce improvements in attention (Conners CPT 3) relative to music listening.

H3: Piano training will produce improvements in working memory (WISC - Digit span) relative to music listening.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • The Mind Research Network
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children must receive a research designation of FASD
  • Children must have confirmed prenatal alcohol exposure

Exclusion Criteria:

  • Children with other confirmed developmental disorders that are not deemed associated with FASD (e.g. autism spectrum disorder, Down Syndrome). Children with attention deficits (e.g. ADHD) are not excluded.
  • Children with neurological disorders (epilepsy, cerebral palsy, etc.)
  • Children who have experienced a traumatic brain injury with loss of consciousness >10 minutes
  • Children with intelligence quotient scores <70
  • Children who are, or become, a ward of the state; however children with a legal representative who can consent on their behalf will not be excluded
  • Children with ongoing music training outside of school or >1 year of prior private music lessons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Music listening then piano training
Participants will listen to music for 10 minutes per day for 12 weeks. After one week of assessments, participants will practice piano for 10 minutes per day for 12 weeks.
Behavioral: Music listening
Daily music listening
Behavioral: Piano training
Daily piano practice
Experimental: Piano training then music listening
Participants will practice piano for 10 minutes per day for 12 weeks. After one week of assessments, participants will listen to music for 10 minutes per day for 12 weeks.
Behavioral: Music listening
Daily music listening
Behavioral: Piano training
Daily piano practice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of behavioral regulation - Inhibit
Time Frame: 12 weeks
The inhibit subscale from the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF 2) Inhibit subscale; min/max: t score: 35 - >90; higher score means more impairment
12 weeks
Assessment of Attention using the Conners Continuous Performance Test
Time Frame: 12 weeks
Examine change in sustained attention based on the Conners Continuous Performance Test - Third Edition (CPT 3): Omission subscale; min/max: t score: <40 - >90; higher score means more impairment
12 weeks
Assessment of Working Memory using Wechsler Intelligence Scale for Children (WISC V)
Time Frame: 12 weeks
Wechsler Intelligence Scale for Children - Fifth Edition (WISC V): Digit Span Backwards subtest, min/max: scaled score: 1 - 19; higher score means better performance.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of cognitive flexibility
Time Frame: 12 weeks
The Shift subscale from the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF 2) Shift subscale; min/max: t score: 35 - >90; higher score means more impairment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Mind Research Network

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be uploaded to the NIAAA-data archive.

IPD Sharing Time Frame

Upon completion of the study

IPD Sharing Access Criteria

NIAAA-DA data sharing guidelines

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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