Family Help Program: Nighttime Enuresis Treatment Program

Enuresis Clinical Trial

Official title:

Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Enuresis)

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

• Enuresis
• Nocturnal Enuresis
• Urinary Incontinence

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

External Links

•   Family Help Program