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

NCT ID: NCT00267605

Last Updated: 2017-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Attention Deficit/Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

FHPADHD 50% randomized to receive Strongest Families (formerly Family Help Program): behavioural distance intervention

Group Type EXPERIMENTAL

FHPADHD

Intervention Type BEHAVIORAL

Evidence-based psychological and behavioural distance intervention

Control

ADHD Standard Care 50% randomized to receive standard/usual care for ADHD

Group Type ACTIVE_COMPARATOR

ADHD Standard Care

Intervention Type BEHAVIORAL

Interventions

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FHPADHD

Evidence-based psychological and behavioural distance intervention

Intervention Type BEHAVIORAL

ADHD Standard Care

Intervention Type BEHAVIORAL

Other Intervention Names

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Strongest Families (formerly Family Help Program):

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

IWK Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick J. McGrath, PhD.

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Locations

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IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 17227604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19270846 (View on PubMed)

Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25.

Reference Type BACKGROUND
PMID: 18025870 (View on PubMed)

Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001.

Reference Type BACKGROUND
PMID: 18632994 (View on PubMed)

Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101.

Reference Type RESULT
PMID: 18632997 (View on PubMed)

Lingley-Pottie P, Janz T, McGrath PJ, Cunningham C, MacLean C. Outcome progress letter types: parent and physician preferences for letters from pediatric mental health services. Can Fam Physician. 2011 Dec;57(12):e473-81.

Reference Type RESULT
PMID: 22170209 (View on PubMed)

McGrath PJ, Lingley-Pottie P, Thurston C, MacLean C, Cunningham C, Waschbusch DA, Watters C, Stewart S, Bagnell A, Santor D, Chaplin W. Telephone-based mental health interventions for child disruptive behavior or anxiety disorders: randomized trials and overall analysis. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1162-72. doi: 10.1016/j.jaac.2011.07.013. Epub 2011 Sep 3.

Reference Type RESULT
PMID: 22024004 (View on PubMed)

Related Links

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Other Identifiers

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CHIR CAHR-43273

Identifier Type: -

Identifier Source: secondary_id

2234c

Identifier Type: -

Identifier Source: org_study_id

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