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

Trial Summary

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 data supports the effectiveness of the treatment Music Training, Music Therapy, Musical Intervention, Piano Training for Fetal Alcohol Spectrum Disorders?

Music-based interventions have shown positive effects in children, helping with emotional disorders and developmental areas. Additionally, music therapy can aid in stress and anxiety management, which may be beneficial for individuals with Fetal Alcohol Spectrum Disorders. ^{1 2 3 4 5}

Is music training safe for humans?

Music-based interventions, including music therapy and music training, are generally used safely across various age groups and conditions to help manage stress, anxiety, and other symptoms. ^{2 3 5 6 7}

How does music training differ from other treatments for Fetal Alcohol Spectrum Disorders?

Music training is unique because it engages multiple brain areas involved in cognitive, emotional, and social processing, potentially enhancing communication and listening skills, which are often affected in Fetal Alcohol Spectrum Disorders. Unlike standard treatments, music training uses musical activities to stimulate brain development and improve auditory processing, offering a non-invasive and enjoyable approach to therapy. ^{8 9 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A review of music-based intervention reporting in pediatrics. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Reporting guidelines for music-based interventions. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Reporting Guidelines for Music-based Interventions. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Music-based intervention in children]. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Study Examining the Effects of Music Training on Attention in Children with Fetal Alcohol Spectrum Disorders (FASD). [2022]

8. France pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England 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! [2016]

11. United States pubmed.ncbi.nlm.nih.gov

A neuroscientific perspective on music therapy. [2022]

12. England pubmed.ncbi.nlm.nih.gov

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