Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior
Condition: Disruptive Behavior Disorder
MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of the Strongest Families Finland Canada project is to help parents develop skills
      to strengthen their families and reduce disruptive behavior in their 4 year old children.
    

Detailed description: 
      This project will have two phases, described below. The first part will be development of the
      web based program, the second part will be the implementation of the program in Finland. All
      participants will be recruited in Finland and all research activities will take place in
      Finland, by the Finnish Consortium. The Canadian Consortium will assist in funding and
      provide expert support.

      Part 1: Website development:

      The Strongest families program provides evidence based psychological and behavioural
      interventions to families with children with mild to moderate mental health problems. Parents
      work through a handbook with exercises, watch instructional videos and participate in weekly
      phone calls from a trained 'coach' (paraprofessional) to provide support, respond to parents'
      questions and highlight the skills included in a handbook. The preliminary analysis of a
      Strongest Families effectiveness trial based at the Izaak Walton Killam Children's Hospital
      (IWK) Health Centre (Projects #2234, and #2654) and effect size reports from the IWK
      Strongest families Service Program suggest that Strongest Families is an effective treatment
      for Oppositional Defiant Disorder (ODD).

      Strongest Families is an adaptation of the COPE program. COPE is a large-group parent
      training program (average 25 families per group) that has been evaluated and used in many
      centres across Canada, the United States and Europe. It was developed at McMaster University
      by a team led by Dr. Charles Cunningham (one of the investigators on this submission). The
      groups use a coping modelling problem solving approach to skill acquisition which encourages
      parents to discuss the solution to common problems, collaborate in the formulation of child
      management strategies, share successes, and provide supportive feedback. Large group
      discussions may also provide more information regarding normal child development and a
      greater perspective on common child management difficulties than clinic/individual parent
      training .

      The benefits for parents participating in COPE group sessions are many, but the burden of
      traveling to receive services can impede attendance, especially for families in rural areas.
      One solution to this issue would be to adapt individualized Strongest Families to a more
      accessible mode.

      We propose to develop a web-based version of Strongest Families in preparation for a
      Randomized Control Trial (RCT) in Finland. All components of web site will be developed using
      a collaborative approach with active participation by all members of the research team. We
      will review each of the component as it is developed. We estimate a minimum of three rounds
      of testing for each component. The program will be evaluated using the user-interface so that
      we review the website and all its various features in a manner that simulates the actual
      parent experience. No qualitative or quantitative data will be recorded for this phase of the
      project. No participants will be recruited for this phase of the trial.

      The web version of Strongest Families will have two components. First, is a personalized
      website that tracks and uses all activities and interactions to modify the Strongest Families
      intervention as the user progresses through the sessions. Interactions include questions,
      surveys, and polls which will be asked periodically throughout the program (for examples see
      Appendix A). Second, the parenting skills curriculum will be based on our Strongest Families
      program, an approach derived from programs developed by members of this team18,19. Third,
      parents , using pseudonyms, will participate in a discussion board/blog to exchange ideas.
      Pseudonyms will be chosen by the participant, but will not include any identifying elements.

      Part 2: Randomized trial (Conducted in Finland, no Canadian recruitment)

      The centerpiece project will be a population-based RCT of high risk 4 year olds attending
      well-child clinics in Turku and environs. Families of children with behavioural challenges
      fort he last six months, scoring 5 points or more on the Conduct subscale of the Strengths
      and Difficulties Questionnaire (SDQ) and with some perceived problems by the parent in the
      impact section of the SDQ will be offered participation in a 2 arm trial. All data will be
      collected in Finland and stored at the University of Turku. All forms/scripts/ measures will
      be administered in Finnish or Swedish. This project has been approved by the Intermunicipal
      Hospital District of Southwest Finland. The Canadian team will provide expert and financial
      support.

      Treatment Group: Families randomized to Web-Enhanced Strongest Families (described above)
      will receive the website program described above.

      Control Group: Families randomized to Educational Control will receive access to a static
      website with parenting tips as well as a 45 coaching call to review the parenting tips.

      Randomization: (1:1 treatment: control; stratified by sex). Randomization sequences were
      generated by a qualified expert at arms length to the trial using a random permuted block
      sequence generator then concealed the placements using a double envelop system labeled with
      sequential numbers. Study staff were blinded to placements until randomization was completed
      by a study staff delegate.
    

Intervention name(s): Strongest Families
Intervention type(s): Behavioral
Intervention description(s): Behavioural intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention