Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267566
Status:
COMPLETED
Last Update Posted:
2013-09-12
First Post:
2005-12-19
Brief Title:
Strongest Families Formerly Family Help Program Pediatric Anxiety
Sponsor:
IWK Health Centre
Organization:
IWK Health Centre
Study Overview
Official Title:
Strongest Families Formerly Family Help Program Primary Care Delivery by Telephone for Psychological and Behavioural Problems Pediatric Anxiety
Status:
COMPLETED
Status Verified Date:
2013-09
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:
FHP-ANX
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 Anxiety symptomology This is a single-center trial based at the IWK Health Center The primary outcome is change in diagnosis
Detailed Description:
The purpose of the Strongest Families formerly Family Help Programis to deliver primary care mental health services to children and their families in the comfort and privacy of their own home Approximately 128 children 6-12 years of agesuffering from mild to moderate but clinically significant symptoms of pediatric anxiety will be randomized
The intervention is delivered from a distance using educational materials manuals video-tapes audio-tapes 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
Fifty percent of the eligible participants will receive Strongest Families formerly Family Help Program telephone-based treatment and 50 will be referred back to their family physician to receive standard care as determined by that physician Those receiving standard care will be evaluated for outcome results and then compared to the Family Help treated participants It is anticipated that Family Help treatment will be proven to be as or more effective than standard care
The intervention is delivered from a distance using educational materials manuals video-tapes audio-tapes 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
Fifty percent of the eligible participants will receive Strongest Families formerly Family Help Program telephone-based treatment and 50 will be referred back to their family physician to receive standard care as determined by that physician Those receiving standard care will be evaluated for outcome results and then compared to the Family Help treated participants It is anticipated that Family Help treatment will be proven to be as or more effective than standard care
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 |
|---|---|---|---|
| CIHR CAHR-43273 | None | None | None |