Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338429
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2006-06-15
Brief Title:
Better Days Better Nights Treatment for Sleep Difficulties Telephone Coached
Sponsor:
IWK Health Centre
Organization:
IWK Health Centre
Study Overview
Official Title:
Better Days Better Nights Treatment for Sleep Difficulties A Sleep Intervention Module of the Family Help Program
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Sleep
Brief Summary:
The purpose of the Strongest Families formerly Family Help Programis to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate sleep onset latency andor bedtime resistance difficulties This is a single-centre trial based at the IWK Health Centre The primary outcome is change in sleep patterns sleep onset latency andor bedtime resistance
Detailed Description:
The purpose of the Family Help Sleep Program is to deliver primary care mental health services to children and their families in the comfort and privacy of their own home Approximately 80 children 6-12 years of agesuffering from mild to moderate sleep onset latency andor bedtime resistance will be randomized
The intervention is delivered from a distance using an educational handbook and telephone consultation with a trained paraprofessional coach who is supervised by a licensed health care professional The telephone coach delivers consistent care based on written protocols with on-going evaluation by a professional team
The intervention is delivered from a distance using an educational handbook and telephone consultation with a trained paraprofessional coach who is supervised by a licensed health care professional The telephone coach delivers consistent care based on written protocols with on-going evaluation by a professional team
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NSHRF grant | OTHER | nshrf | None |