Strongest Families Ontario (Formerly the Family Help Program) (SF-ON)
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|ClinicalTrials.gov Identifier: NCT01473511|
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Oppositional Defiant Disorder Behaviour Disorder||Behavioral: Strongest Families Intervention (formerly Family Help)||Phase 3|
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 non-professional'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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Strongest Families Program + Usual care
50% randomized to receive Strongest Families intervention immediately as well as the usual care services available via the referring agency for the 22 month study period.
Behavioral: Strongest Families Intervention (formerly Family Help)
Distance HEALTH education intervention focussed on skill learning for parents
Other Name: formerly the Family Help Program
No Intervention: Usual care
50% randomized will not receive Strongest Families Intervention during the 22 month study phase, but will receive the usual care services available via the referring agency. At the end of the 22 month study period study participants will be offered the Strongest Families Intervention services.
- Child Behaviour Checklist [ Time Frame: Baseline, 5, 10, 16, 22 months ]Results will be analyzed as change from baseline over time
- Alabama Parenting questionnaire [ Time Frame: Baseline, 5, 10, 16, 22 months ]Results will be analyzed as change from baseline over time
- SCAPI (economic) [ Time Frame: Baseline,5, 10, 16, 22 ]Results will be analyzed as change from baseline over time
- DASS-21 [ Time Frame: Baseline,5, 10, 16, 22 ]Results will be analyzed as change from baseline over time
- Investigator designed Satisfaction measure [ Time Frame: end of intervention ]Participant satisfaction with this psychological intervention will be measured at the end of intervention that varies between participants, but on average is about 5 months post-randomization
- Investigator designed disability measure [ Time Frame: weekly during intervention ]Results will be analyzed as change from baseline over time
- Discrete Conjoint Preference survey: Investigator designed [ Time Frame: baseline, 5, 16 months ]We will examine if discrete choice data collected at baseline predicts participation, adherence and outcome. We will also explore changes in preferences over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473511
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3J 3G9|
|Principal Investigator:||Patrick J McGrath, PhD||Vice President of REsearch Services|