NCT00267566

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 Anxiety symptomology. This is a single-center trial based at the IWK Health Center. 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
91

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 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

August 1, 2003

Completed
2.4 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
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

September 12, 2013

Status Verified

September 1, 2013

Enrollment Period

4.1 years

First QC Date

December 19, 2005

Last Update Submit

September 11, 2013

Conditions

Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Diagnosis using KSADS

    baseline, 120, 240 and 365 day follow-up.

Secondary Outcomes (5)

  • Symptomology frequency as evidenced by diary data;

    daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization

  • Anxiety specific measure (MASC- self-report);

    baseline, 120, 240 and 365 day follow-up

  • Disability Measure;

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

  • Child Health Questionnaire

    baseline, 120, 240 and 365 day follow-up

  • Economic Outcome assessment

    baseline, 120, 240 and 365 day follow-up

Study Arms (2)

Treatment

EXPERIMENTAL

50% random assignment to receive Family Help Anxiety Treatment

Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program

Control

EXPERIMENTAL

50% random assignment to control group to receive usual/standard care for anxiety

Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program

Interventions

Strongest Families (formerly Family Help Program): Anxiety ProgramBEHAVIORAL

Evidence-based psychological and behavioural distance intervention

Also known as: Strongest Families (formerly Family Help Program)
ControlTreatment

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • child 6 to 12 years of age
  • child had Anxiety symptoms for 6 months or longer
  • access to a telephone in the home
  • speak and write english
  • mild to moderate anxiety symptomology

You may not qualify if:

  • severe anxiety symptomology
  • received similar intervention within past 6 months
  • excessive anxiety following a significant traumatic event

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

  • 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. 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

  • 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. 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

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental 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

August 1, 2003

Primary Completion

September 1, 2007

Study Completion

April 1, 2008

Last Updated

September 12, 2013

Record last verified: 2013-09

Locations

CA(1)