Fetal Alcohol Spectrum DisordersSynchronyNCT06005181
The Synchrony Study: Examining Music Training for Children With FASD
A study testing Music listening and Piano training in people with Fetal Alcohol Spectrum Disorders, run by The Mind Research Network at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Music listening and Piano training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children must receive a research designation of FASD
- Children must have confirmed prenatal alcohol exposure
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Mind Research Network
Albuquerque, New Mexico, 87106
Sadie LaBauve, PhD, 505-272-8739, slabauve@mrn.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Music listening, Piano training
- Keywords
- music training, music listening, piano training, attention
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningBehavioural
Daily music listening
Piano trainingBehavioural
Daily piano practice
| Study group | Role | What they receive |
|---|---|---|
| Music listening then piano training | Experimental | 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. Receives: Behavioral: Music listening; Behavioral: Piano training |
| Piano training then music listening | Experimental | 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. Receives: Behavioral: Music listening; Behavioral: Piano training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of behavioral regulation - Inhibit
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
Measured: 12 weeks
Assessment of Attention using the Conners Continuous Performance Test
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
Measured: 12 weeks
Assessment of Working Memory using Wechsler Intelligence Scale for Children (WISC V)
Wechsler Intelligence Scale for Children - Fifth Edition (WISC V): Digit Span Backwards subtest, min/max: scaled score: 1 - 19; higher score means better performance.
Measured: 12 weeks
Secondary outcomes (1)
Assessment of cognitive flexibility
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start2 Oct 2023
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This randomized cross-over design will employ two arms: music listening and piano training. Participants and outcomes assessor will be masked to which arm is active/passive.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Mind Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico
- Responsible party
- Principal investigator, Julia Stephen, The Mind Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005181
- Sponsor's protocol ID
- 23-052
- Acronym
- Synchrony
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be uploaded to the NIAAA-data archive.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Synchrony Study: A Randomized Controlled Trial of Music Training for Children With a Fetal Alcohol Spectrum Disorder (FASD)
- ClinicalTrials.gov ID
- NCT06005181
- Acronym / sponsor ID
- Synchrony / 23-052
- Conditions
- Fetal Alcohol Spectrum Disorders
- Keywords
- music training, music listening, piano training, attention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The Mind Research NetworkUniversity, hospital or other
- Collaborators
- University of New Mexico
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Aug 2023 (actual)
- 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized cross-over design will employ two arms: music listening and piano training. Participants and outcomes assessor will be masked to which arm is active/passive.
| Arm | Type | Receives |
|---|---|---|
| Music listening then piano training | Experimental | Behavioral: Music listening, Behavioral: Piano trainingParticipants 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. |
| Piano training then music listening | Experimental | Behavioral: Music listening, Behavioral: Piano trainingParticipants 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children must receive a research designation of FASD
- Children must have confirmed prenatal alcohol exposure
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Music listeningDaily music listening | Behavioural | Music listening then piano training, Piano training then music listening |
| Piano trainingDaily piano practice | Behavioural | Music listening then piano training, Piano training then music listening |
Primary outcome
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
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
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.
1 secondary outcome
Assessment of cognitive flexibility
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be uploaded to the NIAAA-data archive.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening and Piano training in people with Fetal Alcohol Spectrum Disorders, run by The Mind Research Network 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia M Stephen, PhD (505-272-5028, JSTEPHEN@MRN.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of behavioral regulation - Inhibit (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 Aug 2026.