Home » Trials » SLCTR/2009/011
Effectiveness of a parent implemented early intervention programme for autism: an option for a low resource setting
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SLCTR Registration Number
SLCTR/2009/011
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effectiveness of a parent implemented early intervention programme for autism: an option for a low resource setting
Public Title of Trial
Results of a therapy programme implemented by parents in home setting
Disease or Health Condition(s) Studied
Autistic spectrum disorder
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
LRH/D/06/2009 (Ethics Review Committee of the Lady Ridgeway Hospital, Colombo)
What is the research question being addressed?
Is parent implemented home based early intervention programme effective and feasible?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
Design: The study is an open intervention trial. Sample: Children aged 18 to 48 months recruited to the programme from among those referred to a tertiary care child mental health service for assessment and diagnosis of autism. Comprehensive interview of the parents and observation of child’s behaviour will be carried out in a clinical setting and to make a diagnosis using DSM IV TR criteria Parents are trained a range of strategies to use to facilitate social connectedness in the child and are followedup monthly. The outcome of intervention is objectively assessed at 3 months and 6 months after the initiation of the programme using 5 separate parameters to measure the outcome ((i) eye contact, (ii) pointing, (iii) response to name, (iv) interaction, (v) imitation )
For training, parents will be seen individually. Following an initial education on autism, parents are taught a range of strategies to use to facilitate social communication skills in the child.
Inclusion criteria
All children aged 18 to 48 months diagnosed with autism
Exclusion criteria
Other pervasive development disorders and children with global developmental delay
Primary outcome(s)
|
1.
Improvement in five selected parameters-eye contact , response to name, Interaction with Parents, Imitative behaviour and pointing |
[ At 3 months and 6 months ] |
Secondary outcome(s)
|
1.
Improvement in speech and language |
[ At 3 months and 6 month ] |
Target number/sample size
100
Countries of recruitment
Sri Lanka
Anticipated start date
2009-10-01
Anticipated end date
2010-05-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2008-09-12
Approval number
LRH/D/06/2009
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Lady Ridgeway Hospital, Colombo |
| Institutional Address: | Dr. Dennister De Silva Mawatha, Colombo 0800, Sri Lanka |
| Telephone: | Not Available |
| Email: | Not Available |
Contact person for Scientific Queries/Principal Investigator
Hemamali Perera
Professor in Psychological Medicine
Department of Psychological Medicine, Faculty of Medicine, Kynsey Road, Colombo 8
+94777354616
hemamali_p@yahoo.com
Contact Person for Public Queries
Hemamali Perera
Professor in Psychological Medicine
Department of Psychological Medicine, Faculty of Medicine, Kynsey Road, Colombo 8
+94777354616
hemamali_p@yahoo.com
Primary study sponsor/organization
Lady Ridgeway Hospital
Maradana Road, Colombo
+94112693711
camhu.lrh@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
