Music is the Key: The impact of therapeutic listening on the development of children born preterm
| ISRCTN | ISRCTN99326699 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99326699 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/04/2016
- Registration date
- 19/04/2016
- Last edited
- 05/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
About 11% of all babies born worldwide are preterm (premature) meaning that they are born more than three weeks before their due date. Premature babies have had less time to develop in the womb, and so often have a low birth weight. Although some premature children do very well at school, generally they have a higher chance of developing attention problems or learning difficulties than other children of the same age. It is thought that the earlier a child was born and the lower the weight at birth, the higher this risk becomes. Therapeutic Listening is a programme designed to improve cognitive function (learning, thinking and memory) and attention by using different sounds designed to stimulate brain activity. The aim of this study is to find out what effect Therapeutic Listening has on the cognitive development of children born prematurely who had a very low birth weight.
Who can participate?
Children aged three to four with attention and/or learning difficulties who had an extremely low weight when they were born.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the Therapeutic Listening Programme. This involves children listening to modified music for 20-30 minutes twice per day for five days per week for a period of 6 months. The modified music sections is played on a San Disk Sports Clip (MP3 player) and played through sennheiser HD500A headphones which are specifically designed for the Therapeutic Listening programme. Those in the second group continue as normal and do not take part in any additional therapy. Participants in both groups are assessed by a Speech and Language Therapist, an Occupational Therapist and a Psychologist at the start of the study and after six months. Children who receive the Therapeutic Listening are also assessed every six weeks throughout the programme to monitor their progress.
What are the possible benefits and risks of participating?
Participants may benefit from improved attention and listening skills, language skills and motor skills, which will enhance learning skills. There are no notable risks involved with taking part in the study.
Where is the study run from?
National Maternity Hospital (Ireland)
When is the study starting and how long is it expected to run for?
February 2016 to December 2016
Who is funding the study?
Private individual (Ireland)
Who is the main contact?
1. Ms Marie Slevin (public)
2. Ms Karen O’Connor (scientific)
enquiries@thechilddevelopmentcentre.com
Contact information
Scientific
National Maternity Hospital
Holles Street
Dublin
D02YH21
Ireland
 ORCID ID |
0000-0002-7572-5925 |
|---|
Scientific
The Child Development Centre
Knocknavaddy
Furbo
Galway County
00000000
Ireland
| Phone | +353 87 2137025 |
|---|---|
| enquiries@thechilddevelopmentcentre.com |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | ISRCTN99326699_PIS_Parents.doc |
| Scientific title | A Pilot RCT showing feasibility of Therapeutic Listening for Preterm Infants with Sensory Dysregulation, Attention and Cognitive Problems |
| Study hypothesis | The aim of this study is to identify an effective treatment programme within this population of preterm children that could become an integral part of their developmental pathway going forward to ensure that they achieve their full potential in listening, attention, motor,language and learning. |
| Ethics approval(s) | Ethics Research Committee Board, National Maternity Hospital, Holles Street, Dublin, 04/012016 |
| Condition | Development in premature infants |
| Intervention | Participants are randomly allocated to one of two groups. Intervention group: Participants undergo the home Therapeutic Listening Programme. This involves listening to modified music for 20-30 minutes twice per day for five days per week for a period of 6 months. The intervention group will be reviewed at 6 weekly intervals for monitoring, parent reviews and updating programme input as determined by progress being made. Control group: Participants continue as normal without receiving any intervention. Participants in both groups undergo 6 tests administered by a Speech and Language Therapist, and Ocupational Therpist and a Psychologist at baseline and six months. |
| Intervention type | Other |
| Primary outcome measure | 1. Speech and language skills are measured using the Preschool Language Scales–5 and the Renfrew Action Picture Test (RAPT) at baseline and 6 months 2. Motor skills are measured using the Development of Attention Skill Scale at baseline and 6 months 3. Sensory skills are measured using the Winnie –Dunn Sensory Profile at baseline and 6 months 4. Cognitive development ((Verbal Comprehension Index; Visual Spatial Index; Working Memory Index; Full Scale IQ) is measured uisng the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) at baseline and 6 months |
| Secondary outcome measures | Intervention group only: 1. Child's response to the programme, how consistent the programme has been, motor changes, speech and language changes, behavioural changes, social changes, self-care routine changes and learning changes are measured using the Home Listening Follow-up Form completed by parents on review dates (Wed 30th March 2016; Wed 4th May 2016; Wed 1st June 2016; Wed 6th July 2016 and during final review Wed 17th Aug 2016) 2. Emotional tone changes (i.e. more irritable/more animated, arousal level changes, motor changes, speech and language changes and behavioural changes) are measured through the listening therapist’s observations on review dates (Wed 30th March 2016; Wed 4th May 2016; Wed 1st June 2016; Wed 6th July 2016 and during final review Wed 17th Aug 2016) |
| Overall study start date | 16/10/2015 |
| Overall study end date | 20/12/2016 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 4 Years |
| Sex | Both |
| Target number of participants | 24 |
| Total final enrolment | 22 |
| Participant inclusion criteria | 1. Aged 3 to 4 years 2. Extremely Low Birth Weight Infant (<1500g) 3. Identified as being at risk for attention/learning difficulties when assessed at 2 years corrected age |
| Participant exclusion criteria | 1. Major complications/intellectual impairment i.e. Bayley scores >2SD below the mean 2. Hearing/visual impairment 3. Cerebral palsy 4. Currently taking medication 5. Life-limiting condition/acquired brain injury/seizures 6. Undergoing therapeutic listening. |
| Recruitment start date | 25/09/2015 |
| Recruitment end date | 15/02/2016 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
D02YH21
Ireland
Sponsor information
Other
Holles Street
Dublin
D02YH21
Ireland
| Phone | +353 1 6373100 |
|---|---|
| mslevin@nmh.ie | |
"ROR" |
https://ror.org/03jcxa214 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plan to publish study results in a peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Marie Slevin, email: mslevin @nmh.ie subject to ethical approval from the National Maternity Hospital’s Ethics Committee’s board approval and data protection legislation . |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 19/04/2016 | No | Yes | ||
| Basic results | 14/12/2017 | 25/01/2018 | No | No | |
| Results article | results | 01/01/2020 | 05/02/2020 | Yes | No |
Additional files
- ISRCTN99326699_PIS_Parents.doc
- Uploaded on 19/04/2016
- ISRCTN99326699_BasicResults_14Dec17.pdf
- Uploaded 25/01/2018
Editorial Notes
05/02/2020: Publication reference and total final enrolment number added.
25/01/2018: The following changes have been made:
1. The scientific title has been updated from "Music is the Key: Optimising Neurodevelopmental Outcome for the Preterm Infant" to "A Pilot RCT showing feasibility of Therapeutic Listening for Preterm Infants with Sensory Dysregulation, Attention and Cognitive Problems"
2. The intention to publish date has been updated from 30/06/2017 to 01/06/2018.
3. The participant level data sharing statement has been added.
4. The basic results of this trial have been uploaded as an additional file.
