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NCT03188016
Improvised Music to Enhance Intensive Interaction Version 1
NA trial testing Intensive Interaction with Music in Child Development Disorders, Specific. Withdrawn.
2 March 2018
Quick facts
| Lead sponsor | Beacon Hill Academy |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 23 October 2017 |
| Primary completion | 2 March 2018 |
| Estimated completion | 1 June 2018 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Intensive Interaction with Music
- Standard Intensive Interaction
Conditions studied
- Child Development Disorders, Specific — all drugs for Child Development Disorders, Specific →
- Developmental Communication Disorders — all drugs for Developmental Communication Disorders →
Sponsor
Beacon Hill Academy
Who can join
Adults 3 to 15, any sex, with Child Development Disorders, Specific or Developmental Communication Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The project will investigate the effectiveness of a specialised musical-clinical approach used as an adjunct to an established non-musical intervention in the enhancement of interpersonal interaction. 6 school pupils with profound disability will be randomly allocated to experimental and control groups. The control group will receive only Intensive Interaction for 16 sessions. The experimental group will receive four sessions of Intensive Interaction, followed by twelve sessions of Intensive Interaction plus improvised music. Music therapists will follow a flexible manual written to ensure that their music supports the interaction between pupil and learning support assistant (LSA) without direct social interaction with either. Changes in capacity for interpersonal interaction will be assessed by a standardised assessment instrument, the Pre-Verbal Communication Schedule (PVCS), administered to both experimental and control groups before the 1st session and after the 16th session. There will also be a qualitative process study of the experimental group conducted by video observation by the researchers involved. The project is funded in equal shares by the Music Therapy Charity and Beacon Hill Academy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03188016 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beacon Hill Academy
- Last refreshed: 3 May 2018
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