Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-04 @ 6:59 PM
Study NCT ID:
NCT02792894
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2016-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Networks (FaNs) for Children With Developmental Disorders and Delays
Sponsor:
Human Development Research Foundation, Pakistan
Organization:
Study Overview
Official Title:
Evaluation of Family Networks (FaNs) for Children With Developmental Disorders and Delays Program: A Cluster Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FaNs
Brief Summary:
Over 6% of children in Pakistan suffer from a developmental disorder (intellectual disability or Autistic spectrum disorder) and most receive no intervention.In an earlier proof of concept study, the investigators integrated social, technological and business innovations to develop and successfully pilot a sustainable service for such children in one rural population of 30,000. Affected families were identified through a mobile phone-based interactive voice response system, and organised into family networks. 'Champion' family volunteers were trained in evidence-based interventions. A Tablet-based android application was developed for training, monitoring and supervision of the champions, based on the World Health Organization's guidelines. The champions delivered the intervention to other families in the network. The project was sustainable and demonstrated significant improvements in the lives of children and their families in the first 6 months of its operation. The investigators are scaling-up this intervention to a population of 1 million. The investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up programme using cluster randomized control trial nested within the scale-up study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: