Strongest Families Ontario (Formerly the Family Help Program)

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Brief Title

Strongest Families Ontario (Formerly the Family Help Program)

Official Title

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 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.
    

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 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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Child Behaviour Checklist

Secondary Outcome

 Alabama Parenting questionnaire

Condition

Oppositional Defiant Disorder

Intervention

Strongest Families Intervention (formerly Family Help)

Study Arms / Comparison Groups

 Strongest Families Program + Usual care
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

172

Start Date

February 2010

Completion Date

December 2015

Primary Completion Date

February 2015

Eligibility Criteria

        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)
      

Gender

All

Ages

6 Years - 12 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Patrick J McGrath, PhD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01473511

Organization ID

4839

Secondary IDs

MCT-91030

Responsible Party

Sponsor

Study Sponsor

IWK Health Centre

Collaborators

 Canadian Institutes of Health Research (CIHR)

Study Sponsor

Patrick J McGrath, PhD, Principal Investigator, Vice President of REsearch Services


Verification Date

September 2016