Music is the Key: The impact of therapeutic listening on the development of children born preterm

• Register: ISRCTN
• Last refreshed on: 24 February 2020
• Main ID: ISRCTN99326699
• Date of registration: 19/04/2016
• Prospective Registration: No
• Primary sponsor: National Maternity Hospital
• Public title: Music is the Key: The impact of therapeutic listening on the development of children born preterm
• Scientific title: A Pilot RCT showing feasibility of Therapeutic Listening for Preterm Infants with Sensory Dysregulation, Attention and Cognitive Problems
• Date of first enrolment: 25/09/2015
• Target sample size: 24
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN99326699
• Study type: Interventional
• Study design: Single-centre randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Ireland

Contacts

• Name: Marie Slevin

Key inclusion & exclusion criteria

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

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.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Development in premature infants
Mental and Behavioural Disorders
Development in premature infants

Intervention(s)

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(s)

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(s)

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)

Secondary ID(s)

N/A

Source(s) of Monetary Support

Private individual

Ethics review

Status:
Approval date:
Contact:

Ethics Research Committee Board, National Maternity Hospital, Holles Street, Dublin, 04/012016

Results

• Results available: Yes
• Date Completed: 20/12/2016