Strongest Families Ontario (Formerly the Family Help Program) (SF-ON)
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| First Received Date ICMJE | July 22, 2011 | ||||||||
| Last Updated Date | October 2, 2012 | ||||||||
| Start Date ICMJE | February 2010 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Child Behaviour Checklist [ Time Frame: Baseline, 5, 10, 16, 22 months ] [ Designated as safety issue: No ] Results will be analyzed as change from baseline over time |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01473511 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Strongest Families Ontario (Formerly the Family Help Program) | ||||||||
| Official Title ICMJE | Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario | ||||||||
| Brief Summary | Strongest Families (formerly Family Help)is an evidence-based, distance health education model for families who have children with behavioural difficulties. The principal research question is "Does Strongest Families, a 12-week, home-based program of interactive readings, instructional videos, homework projects, and weekly "coaching" telephone calls out perform the care families typically experience when referred to a mental health service?". The investigators hypothesise that children randomised to Strongest Families intervention will show a significantly greater reduction in externalizing behaviour problems than those randomised to a Control (usual care). In addition, parents randomised to Family Help will report a greater improvement in parenting skills and a greater reduction in symptoms of emotional distress (i.e., feeling of anxiety, depression, and stress) than parents in the Control condition. Finally, families randomized to Family Help will use fewer mental health services than Controls. |
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| Detailed Description | Our project is designed to help families and children with mild or moderate symptoms early, before problems become worse and more difficult to treat. The Strongest Families Program is a distance parenting program that was developed at the Centre for Research in Family Health at the IWK Health Centre in Halifax, Nova Scotia. Most families are able to manage these problems if they are given the skills to do so. The Strongest Families "Parenting the Active Child" Distance Program is done over the telephone; families do not have to travel to a centre to receive help. This program includes a handbook, videos and weekly phone calls between the parent and 'coach'. The coach provides support to families, answer questions and guide parents as they learn the skills. Strongest Families has helped hundreds of families in Nova Scotia. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Strongest Families Intervention (formerly Family Help)
Distance HEALTH education intervention focussed on skill learning for parents
Other Name: formerly the Family Help Program |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Male or female individuals who meet all the following criteria are eligible for this trial:
Exclusion Criteria: Participants meeting one or more of the following criteria cannot be selected:
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| Gender | Both | ||||||||
| Ages | 6 Years to 12 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01473511 | ||||||||
| Other Study ID Numbers ICMJE | 4839, MCT-91030 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | IWK Health Centre | ||||||||
| Study Sponsor ICMJE | IWK Health Centre | ||||||||
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | ||||||||
| Investigators ICMJE |
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| Information Provided By | IWK Health Centre | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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