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)
Ms Marie Slevin
National Maternity Hospital
Ms Karen O'Connor
The Child Development Centre
+353 87 2137025
A Pilot RCT showing feasibility of Therapeutic Listening for Preterm Infants with Sensory Dysregulation, Attention and Cognitive Problems
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 Research Committee Board, National Maternity Hospital, Holles Street, Dublin, 04/012016
Single-centre randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Please see additional files
Development in premature infants
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.
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 trial start date
Overall trial end date
Reason abandoned (if study stopped)
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
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
National Maternity Hospital
National Maternity Hospital
+353 1 6373100
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Plan to publish study results in a peer reviewed journal.
IPD sharing statement:
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 .
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
See additional file (ISRCTN99326699_BasicResults_14Dec17)