NCT00267605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

December 19, 2005

Last Update Submit

March 7, 2017

Conditions

Attention Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.

    baseline, 120, 240 and 365 day follow-up

Secondary Outcomes (6)

  • Alabama Parenting Questionnaire

    baseline, 120, 240 and 365 day follow-up

  • Revised Disruptive Disorder Rating Scale

    baseline, 120, 240 and 365 day follow-up

  • Connors rating scale

    baseline, 120, 240 and 365 day followup

  • Disability Measure;

    Weekly during treatment; baseline, 120, 240 and 365 day follow-up

  • Child Health Questionnaire

    baseline, 120, 240 and 365 day follow-up

  • +1 more secondary outcomes

Study Arms (2)

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

FHPADHDBEHAVIORAL

Evidence-based psychological and behavioural distance intervention

Also known as: Strongest Families (formerly Family Help Program):
Treatment
ADHD Standard CareBEHAVIORAL
Control

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (7)

  • 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.

    PMID: 17227604BACKGROUND

  • 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.

    PMID: 19270846BACKGROUND

  • 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.

    PMID: 18025870BACKGROUND

  • 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.

    PMID: 18632994BACKGROUND

  • 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.

    PMID: 18632997RESULT

  • 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.

    PMID: 22170209RESULT

  • 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.

    PMID: 22024004RESULT

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Patrick J. McGrath, PhD.

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2005

First Posted

December 21, 2005

Study Start

June 1, 2003

Primary Completion

June 1, 2006

Study Completion

April 1, 2008

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

CA(1)