Music Training for Fetal Alcohol Spectrum Disorders

(Synchrony Trial)

Overseen By Julia M Stephen, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Mind Research Network

Disqualifiers: Autism, Down Syndrome, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether music training can improve behavior and thinking skills in children exposed to alcohol before birth, who have Fetal Alcohol Spectrum Disorder (FASD). Participants will either listen to music or learn to play the piano for 12 weeks, then switch to the other activity. The trial aims to determine if these activities can enhance attention and memory. Children with an FASD diagnosis and confirmed prenatal alcohol exposure might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative interventions that could enhance cognitive and behavioral outcomes in children with FASD.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants need to stop taking their current medications.

What prior data suggests that music training is safe for children with fetal alcohol spectrum disorders?

Research shows that music training is safe for children, including those with fetal alcohol spectrum disorders (FASD). In one study with 20 children who have FASD, five weeks of piano lessons caused no negative effects. This suggests that both listening to music and playing the piano are manageable activities for children.

Previous research has not identified any safety issues with music training. Music is generally considered low-risk because it doesn't involve chemicals or physical procedures, unlike medications or surgeries.

Additionally, music training is already widely used in schools and therapy, further supporting its safety for studies like this one. While absolute safety cannot be guaranteed, strong evidence indicates that music training is a safe choice for children with FASD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores music training as a novel approach for managing Fetal Alcohol Spectrum Disorders (FASD), which currently rely on behavioral interventions and therapies. Unlike existing treatments, music training involves listening to music and practicing piano, which may uniquely stimulate brain areas involved in cognition and emotion. This could potentially enhance learning, attention, and emotional regulation in ways traditional therapies do not. By using a creative and engaging method, researchers hope to discover if music training can offer a new pathway to support individuals with FASD.

What evidence suggests that music training could be effective for fetal alcohol spectrum disorders?

Research has shown that music training might benefit children with fetal alcohol spectrum disorders (FASD). In one study involving 20 children with FASD, five weeks of piano lessons led to noticeable changes in brain activity. The current trial will explore two sequences of music training: one group will start with music listening followed by piano training, while the other will begin with piano training followed by music listening. Music training could improve attention and memory, areas often challenging for children with FASD. Additionally, music therapy has proven effective for other developmental disorders like autism and ADHD, which share some symptoms with FASD. These findings suggest that music training could support children with FASD in enhancing their thinking and behavior. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children who have been exposed to alcohol before birth and have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). They should be able to participate in daily music activities for 12 weeks.

Inclusion Criteria

Children must have confirmed prenatal alcohol exposure

Children must receive a research designation of FASD

Exclusion Criteria

Children with other confirmed developmental disorders that are not deemed associated with FASD (e.g. autism spectrum disorder, Down Syndrome)

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Music Listening

Participants listen to pre-selected music for at least 10 minutes per day for 12 weeks

12 weeks

Weekly check-ins (virtual)

Intermediate Assessment

Participants undergo cognitive testing, behavioral questionnaires, and neuroimaging

1 week

1 visit (in-person)

Piano Training

Participants practice piano for at least 10 minutes per day for 12 weeks, with weekly ½ hour lessons

12 weeks

Weekly lessons (in-person)

Final Assessment

Participants undergo final cognitive testing, behavioral questionnaires, and neuroimaging

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Music Training

Trial Overview The study tests if piano training or listening to music can help improve behavior and brain functions like attention and memory in kids with FASD. Each child will do both activities, one after the other, for 12 weeks each, with their order chosen randomly.

How Is the Trial Designed?

Group I: Piano training then music listening Experimental Treatment 2 Interventions

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.

Group II: Music listening then piano training Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

The Mind Research Network

Lead Sponsor

Trials

27

Recruited

2,300+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Published Research Related to This Trial

Music-based interventions can effectively address a wide range of issues across all age groups, from infants to the elderly.

To enhance the clarity and consistency of reporting these interventions, a new set of guidelines has been proposed, focusing on key components such as theory, content, and delivery, which align with established reporting standards like CONSORT and TREND.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting guidelines for music-based interventions. Robb, SL., Burns, DS., Carpenter, JS.[2021]

Music-based interventions can be beneficial for individuals of all ages, from infants to the elderly, addressing a wide range of issues.

To enhance the clarity and effectiveness of these interventions, a set of specific reporting guidelines has been proposed, focusing on key components such as intervention theory, content, delivery schedule, and treatment fidelity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting Guidelines for Music-based Interventions. Robb, SL., Burns, DS., Carpenter, JS.[2021]

Listening to and producing music activates various brain areas related to cognitive, emotional, and sensorimotor processing, suggesting a complex interplay of functions that music engages.

The potential psychological and physiological benefits of music therapy are supported by neuroscientific studies, although the exact mechanisms behind these effects are still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A neuroscientific perspective on music therapy. Koelsch, S.[2022]

Music-based interventions are effective for treating health issues and enhancing education in children, positively impacting their emotional and developmental growth.

There is a significant gap in empirical research on music therapy for children, highlighting the need for more studies to explore its applications, treatment goals, and specific mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Music-based intervention in children]. Kiese-Himmel, C.[2012]

Antenatal music activities can effectively help manage stress, anxiety, and depression in expectant mothers, promoting better mental health during pregnancy.

Music interventions can enhance bonding between mother and child, support cognitive and emotional development, and aid in the child's adaptation to their environment, leveraging mechanisms like neuroplasticity for positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal Music Therapy and Antenatal Music Classes: Principles, Mechanisms, and Benefits. Mastnak, W.[2020]

A study involving 20 children with fetal alcohol spectrum disorder (FASD) showed that five weeks of piano training led to significant changes in brain function, particularly in attention and inhibitory control, as measured by EEG responses during the Attention Networks Test.

The music training group exhibited a trend towards improved reaction times compared to the control group, suggesting that short-term music training may enhance cognitive functions in children with FASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study Examining the Effects of Music Training on Attention in Children with Fetal Alcohol Spectrum Disorders (FASD). Gleichmann, DC., Pinner, JFL., Garcia, C., et al.[2022]

Music-based training may enhance speech and language development in children with communication disorders, including those using cochlear implants (CIs), despite the challenges posed by degraded sound processing in CIs.

There is a lack of systematic studies on the effectiveness of music training for CI users, highlighting the need for more research to understand its potential benefits for improving speech skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music-based training for pediatric CI recipients: A systematic analysis of published studies. Gfeller, K.[2018]

Music-related activities can lead to positive changes in brain structure and function, enhancing auditory cognitive processes in both typically developing individuals and those with auditory processing deficits.

The review highlights the need for improved methodologies in music-based training studies to address error sources and publication bias, which could enhance our understanding of the neural and behavioral benefits of music training in infants and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning music-based amelioration and training in infancy and childhood based on neural evidence. Huotilainen, M., Tervaniemi, M.[2019]

A review of 22 pediatric studies on music-based interventions highlighted significant gaps in how these interventions are reported, particularly in areas like music qualities and intervention delivery methods.

The findings suggest a need for standardized reporting guidelines to enhance the clarity and effectiveness of music-based interventions in research and practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of music-based intervention reporting in pediatrics. Robb, SL., Carpenter, JS.[2022]

In a study involving 126 mechanically ventilated patients in intensive care units, preferred music playlists were analyzed to understand their impact on managing anxiety through patient-directed music listening interventions.

The findings highlight the importance of music selection in therapeutic interventions, suggesting that involving a board-certified music therapist can enhance the effectiveness of music listening protocols in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. Heiderscheit, A., Johnson, K., Chlan, LL.[2023]

The BabyBeats™ musical intervention showed positive effects on early communication and listening skills in infants with hearing loss, as reported by parents and professionals after an 8-month trial involving 15 families in the UK.

Parents noted increased vocalization and engagement from their babies, along with improved confidence in interacting through music, suggesting that musical activities can enhance early cognitive and social development in children with hearing impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing the musical brain to boost early pre-verbal, communication and listening skills: The implications for musicality development pre- and post-cochlear implantation. It is not just about Nursery Rhymes! Rocca, C.[2016]

A review of 18 studies focused on children with reading difficulties found that music and auditory-based interventions can lead to positive improvements in reading skills, particularly in phonological abilities.

While the effects were not consistent across all studies, the findings support the idea that musical training can help enhance literacy skills in struggling readers, suggesting a beneficial transfer effect from music to reading.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music-based and auditory-based interventions for reading difficulties: A literature review. Cancer, A., Antonietti, A.[2022]

Citations

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A Pilot Study Examining the Effects of Music Training on ... We hypothesized that short-term music training in children with an FASD due to prenatal alcohol exposure may improve brain function.

2. researchgate.net researchgate.net/publication/362679237_A_Pilot_Study_Examining_the_Effects_of_Music_Training_on_Attention_in_Children_with_Fetal_Alcohol_Spectrum_Disorders_FASD

(PDF) A Pilot Study Examining the Effects of Music Training ... Therefore, we hypothesized that short-term music training in children with an FASD due to prenatal alcohol exposure may improve brain function.

3. withpower.com withpower.com/trial/phase-fetal-alcohol-spectrum-disorders-8-2023-065f2

Music Training for Fetal Alcohol Spectrum Disorders A study involving 20 children with fetal alcohol spectrum disorder (FASD) showed that five weeks of piano training led to significant changes in brain function ...

4. trialstoday.org trialstoday.org/trial/NCT06005181

Examining Music Training for Children With FASD The goal of this clinical trial is to examine if music training improves behavioral or cognitive performance in children with prenatal alcohol ...

5. auctoresonline.org auctoresonline.org/article/use-and-effectiveness-of-musical-social-story-therapy-in-children-with-developmental-disorders-down-syndrome-autism-spectrum-disorder-fragile-x-syndrome-fetal-alcohol-spectrum-disorder-cerebral-palsy-and-adhd

Use and effectiveness of musical social story therapy in ... Musical social stories are a therapy method with proven effectiveness in the diagnosis of neurological diseases, especially autism and ADHD, as well as Down ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06005181

The Synchrony Study: Examining Music Training for ... The goal of this clinical trial is to examine if music training improves behavioral or cognitive performance in children with prenatal alcohol exposure who ...

7. mdpi.com mdpi.com/1424-8220/22/15/5642

A Pilot Study Examining the Effects of Music Training on ... We hypothesized that short-term music training in children with an FASD due to prenatal alcohol exposure may improve brain function.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35957202/

A Pilot Study Examining the Effects of Music Training on ... We hypothesized that short-term music training in children with an FASD due to prenatal alcohol exposure may improve brain function.