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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00270621
Other study ID # 2234e
Secondary ID CIHR CAHR-43273
Status Completed
Phase Phase 2
First received December 23, 2005
Last updated September 1, 2016
Start date June 2003
Est. completion date April 2008

Study information

Verified date September 2016
Source IWK Health Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Canadian Institutes of Health Research
Study type Interventional

Clinical Trial 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.


Description:

The purpose of the 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 46 children (5-12 years of age)suffering from pediatric enuresis (at least 2 times a week) will be randomized.

The intervention is delivered from a distance, using the urine alarm system accompanied by 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 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 Family Help treated participants. It is anticipated that Family Help treatment will be proven to be as or more effective than standard care.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date April 2008
Est. primary completion date October 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria:

- Is your child 3 to 12 years of age

- child wets the bed more than twice per week

- child dry during the day

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
FHP Night time ENuresis Intervention
Urine alarm/evidence-based psychological Intervention

Locations

Country Name City State
Canada IWK Health Centre Halifax Nova Scotia

Sponsors (2)

Lead Sponsor Collaborator
IWK Health Centre Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. — View Citation

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. — View Citation

Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. baseline, 120, 240 and 365 day follow-up No
Secondary Symptomology frequency as evidenced by diary data; daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization No
Secondary Disability Measure; weekly during treatment; baseline, 120, 240 and 365 day follow-up No
Secondary Child Health Questionnaire baseline, 120, 240 and 365 day follow-up No
Secondary Economic Outcome assessment baseline, 120, 240 and 365 day follow-up No
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