Clinical trial NCT01750996: Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior
Official title: Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Disruptive Behavior Disorder
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-12-17
Enrollment: 464
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Child is 4 years old at time of recruitment
* Parent/guardian has access to a computer and the internet
* Parent/guardian is comfortable reading at a Grade 5 level
* Child meets screening criteria (SDQ score of 4 or more with some problems per impact score)

  * Child has had behavioural challenges for the last 6 months
  * Parent has access to phone in home
  * Parent speaks/writes Finnish

Exclusion Criteria:

* - Has received or is receiving behavioral treatment (parent training) before
* Diagnosis of:

  * Autism or a Pervasive development disorder (PDD)
  * Down's syndrome
  * Fetal Alcohol Syndrome
  * Mental retardation
  * Genetic diagnosis that will lead to mental retardation
  * Major mental health disorder (e.g., depression, psychosis)
* Child is not speaking using a sentence
* Child is deaf or blind

Primary outcomes:
measure: CHild Behaviour Checklist (to measure change from baseline)
timeFrame: Measure change from baseline at 6 & 12 months
Secondary outcomes:
measure: Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish
timeFrame: Baseline, 6 & 12months
measure: The Parenting Scale (To measure change from baseline to 6 & 21 months)
timeFrame: To measure change from baseline to 6 & 12 months post randomization
measure: Barkley's Quick-Screen: The Barkley Adult ADHD Rating Scale IV (to measure change from baseline)
timeFrame: Measure change from baseline to 6&12 months
measure: Child Behaviour Checklist- Teacher version (to measure change since baseline)
timeFrame: Measure change from Baseline to 6 & 12 months
measure: Satisfaction measure: Researcher designed for the Intervention group
timeFrame: end of program intervention (average is about 5 months but timing of completion varies between participants.)
measure: Strengths & Difficulties Questionnaire (Screening Tool)
timeFrame: Screening
measure: The Parent Problem Checklist
timeFrame: Measure change from Baseline to 6 & 12 months
measure: The Sense of Coherence Scale (SOC-13)
timeFrame: Measure change from Baseline to 6 & 12 months
measure: The Inventory of Callous-Unemotional Traits
timeFrame: Measure change from Baseline to 6 & 12 months
Other outcomes:
Locations:
city: TUrku
country: Finland
facility: University of Turku, Finland
Study officials:
affiliation: IWK Health Centre
name: Patrick J McGrath, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGrath PJ, Sourander A, Lingley-Pottie P, Ristkari T, Cunningham C, Huttunen J, Filbert K, Aromaa M, Corkum P, Hinkka-Yli-Salomaki S, Kinnunen M, Lampi K, Penttinen A, Sinokki A, Unruh A, Vuorio J, Watters C. Remote population-based intervention for disruptive behavior at age four: study protocol for a randomized trial of Internet-assisted parent training (Strongest Families Finland-Canada). BMC Public Health. 2013 Oct 21;13:985. doi: 10.1186/1471-2458-13-985.
citation: Sourander A, McGrath PJ, Ristkari T, Cunningham C, Huttunen J, Lingley-Pottie P, Hinkka-Yli-Salomaki S, Kinnunen M, Vuorio J, Sinokki A, Fossum S, Unruh A. Internet-Assisted Parent Training Intervention for Disruptive Behavior in 4-Year-Old Children: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Apr;73(4):378-87. doi: 10.1001/jamapsychiatry.2015.3411.
citation: Sourander A, Ristkari T, Kurki M, Gilbert S, Hinkka-Yli-Salomaki S, Kinnunen M, Pulkki-Raback L, McGrath PJ. Effectiveness of an Internet-Based and Telephone-Assisted Training for Parents of 4-Year-Old Children With Disruptive Behavior: Implementation Research. J Med Internet Res. 2022 Apr 4;24(4):e27900. doi: 10.2196/27900.
citation: Sourander A, McGrath PJ, Ristkari T, Cunningham C, Huttunen J, Hinkka-Yli-Salomaki S, Kurki M, Lingley-Pottie P. Two-Year Follow-Up of Internet and Telephone Assisted Parent Training for Disruptive Behavior at Age 4. J Am Acad Child Adolesc Psychiatry. 2018 Sep;57(9):658-668.e1. doi: 10.1016/j.jaac.2018.07.001. Epub 2018 Aug 3.