Strongest Families (Formerly Family Help Program): Pediat... | NCT00267605

Studies
Strongest Families (Formerly Family Help Program): Pediatric Attention Deficit/Hyperactivity Disorder

NCT00267605

Sponsor

IWK Health Centre

Status

Completed

Last Update Posted

Mar 9, 2017Actual

Enrollment

72Actual

Phase

Phase 2

Conditions

Attention Deficit/Hyperactivity Disorder

Interventions

FHPADHD
ADHD Standard Care

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CHIR CAHR-43273

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Jun 2006Actual

Completion Date

Apr 2008Actual

First Submitted Date

Dec 19, 2005

First Submission Date that Met QC Criteria

Dec 20, 2005

First Posted Date

Dec 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2017

Last Update Posted Date

Mar 9, 2017Actual

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the Strongest Families (formerly Family Help Program)is 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 Attention Deficit/Hyperactivity Disorder. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.

Detailed Description

The purpose of the Strongest Families (formerly Family Help Program): is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 60 children (8-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Attention Deficit/Hyperactivity Disorder 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 Strongest Families treated participants. It is anticipated that Strongest Families treatment will be proven to be as or more effective than standard care.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	FHPADHD 50% randomized to receive Strongest Families (formerly Family Help Program): behavioural distance intervention	Behavioral: FHPADHD
Control	Active Comparator	ADHD Standard Care 50% randomized to receive standard/usual care for ADHD	Behavioral: ADHD Standard Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FHPADHD	Behavioral	Evidence-based psychological and behavioural distance intervention	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.		baseline, 120, 240 and 365 day follow-up

Secondary Outcomes

Measure	Description	Time Frame
Alabama Parenting Questionnaire		baseline, 120, 240 and 365 day follow-up
Revised Disruptive Disorder Rating Scale		baseline, 120, 240 and 365 day follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

child 3 to 7 years of age
child had behavioural problems for 6 months or longer
access to a telephone in the home
speak and write english
mild to moderate attention deficit/hyperactivity symptomology

Exclusion Criteria:

severe attention deficit/hyperactivity symptomology
received similar intervention within past 6 months
Autism or Schizophrenia
child has intellectual impairment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick J. McGrath, PhD.	IWK Health Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IWK Health Centre		Halifax	Nova Scotia	B3K 6R8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17227604	Background	Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690.
19270846	Background	McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders