Strongest Families Ontario (Formerly the Family Help Program) (SF-ON)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01473511
First received: July 22, 2011
Last updated: May 30, 2016
Last verified: May 2016

July 22, 2011
May 30, 2016
February 2010
February 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01473511 on ClinicalTrials.gov Archive Site
  • Alabama Parenting questionnaire [ Time Frame: Baseline, 5, 10, 16, 22 months ] [ Designated as safety issue: No ]
    Results will be analyzed as change from baseline over time
  • SCAPI (economic) [ Time Frame: Baseline,5, 10, 16, 22 ] [ Designated as safety issue: No ]
    Results will be analyzed as change from baseline over time
  • DASS-21 [ Time Frame: Baseline,5, 10, 16, 22 ] [ Designated as safety issue: No ]
    Results will be analyzed as change from baseline over time
  • Investigator designed Satisfaction measure [ Time Frame: end of intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Results will be analyzed as change from baseline over time
  • Discrete Conjoint Preference survey: Investigator designed [ Time Frame: baseline, 5, 16 months ] [ Designated as safety issue: No ]
    We will examine if discrete choice data collected at baseline predicts participation, adherence and outcome. We will also explore changes in preferences over time.
  • Alabama Parenting questionnaire [ Time Frame: Baseline, 5, 10, 16, 22 months ] [ Designated as safety issue: No ]
    Resuls will be analyzed as change from baseline over time
  • SCAPI (economic) [ Time Frame: Baseline,5, 10, 16, 22 ] [ Designated as safety issue: No ]
    Resuls will be analyzed as change from baseline over time
  • DASS-21 [ Time Frame: Baseline,5, 10, 16, 22 ] [ Designated as safety issue: No ]
    Resuls will be analyzed as change from baseline over time
  • Investigator designed Satisfaction measure [ Time Frame: end of intervention ] [ Designated as safety issue: No ]
    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- randommization
  • Investigator designed disability measure [ Time Frame: weekly during intervention ] [ Designated as safety issue: No ]
    Resuls will be analyzed as change from baseline over time
  • Discrete Conjoint Preference survey: Investigator designed [ Time Frame: baseline, 5, 16 months ] [ Designated as safety issue: No ]
    Resuls will be analyzed as change from baseline over time
Not Provided
Not Provided
 
Strongest Families Ontario (Formerly the Family Help Program)
Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario
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 hypothesize that children randomized to Strongest Families intervention will show a significantly greater reduction in externalizing behaviour problems than those randomized to a Control (usual care). In addition, parents randomized 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Oppositional Defiant Disorder
  • Behaviour Disorder
Behavioral: Strongest Families Intervention (formerly Family Help)
Distance HEALTH education intervention focussed on skill learning for parents
Other Name: formerly the Family Help Program
  • 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.
    Intervention: Behavioral: Strongest Families Intervention (formerly Family Help)
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
December 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Male or female individuals who meet all the following criteria are eligible for this trial:

  • Child is aged 6 to 12 years and
  • Completed and signed referral form from a participating intake site is received and
  • Parent/legal guardian provides verbal, telephone consent to participate and
  • Ability of participant to read and understand English (at a Grade 5 level) and
  • There must be the reasonable intention that for the study duration the child will remain in the direct care of the participant and at the same address as the participant (2 years) and o Child presents with significant levels of disruptive behaviour based on the BCFPI results at the referring agent end and clinical evaluation of the corroborative study assessment measures.

Exclusion Criteria:

Participants meeting one or more of the following criteria cannot be selected:

  • Child is in the care of a child protective agency or currently being investigated by a child protective agency
  • Child has received any form of behavioural treatment in the past 6 months
  • Child is at an imminent risk of harm to themselves or others
  • In the judgment of the investigator or delegate, any condition that may interfere with effective delivery of the study protocol/intervention program (i.e., High parental DASS-21 score, complex child symptomology, families who are unmotivated or are in complete chaos)
Both
6 Years to 12 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01473511
4839, MCT-91030
Yes
No
Not Provided
IWK Health Centre
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Patrick J McGrath, PhD Vice President of REsearch Services
IWK Health Centre
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP