NCT00270621

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 Enuresis diagnoses. 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
56

participants targeted

Target at P25-P50 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 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

September 2, 2016

Status Verified

September 1, 2016

Enrollment Period

3.3 years

First QC Date

December 23, 2005

Last Update Submit

September 1, 2016

Conditions

Enuresis

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 (4)

  • Symptomology frequency as evidenced by diary data;

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

  • 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

FHP Night time Enuresis intervention

Behavioral: FHP Night time ENuresis Intervention

Control

NO INTERVENTION

To receive standard/usual care for Nocturnal Enuresis- No FHP Night time Enuresis INtervention

Interventions

FHP Night time ENuresis InterventionBEHAVIORAL

Urine alarm/evidence-based psychological Intervention

Treatment

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Is your child 3 to 12 years of age
  • child wets the bed more than twice per week
  • child dry during the day

You may not qualify if:

  • child received any treatment for bedwetting in the past 6 months
  • child at any time been dry for 6 months or longer
  • child currently on Imipramine or Desmopressin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (6)

  • 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: 18632997BACKGROUND

  • 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

  • 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

  • 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: 17227604RESULT

  • 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: 18025870RESULT

  • Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.

    PMID: 32364251DERIVED

Related Links

MeSH Terms

Conditions

Enuresis

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination 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 23, 2005

First Posted

December 28, 2005

Study Start

June 1, 2003

Primary Completion

October 1, 2006

Study Completion

April 1, 2008

Last Updated

September 2, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Aggregate summary data would be made available but not individual data.

Locations

CA(1)