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Disruptive Behavior DisorderPhase 1/2Fin-CanNCT01750996

Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior

A Phase 1/2 study testing Strongest Families in people with Disruptive Behavior Disorder, run by IWK Health Centre at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 5 yearsHealthy volunteers can take part
Conditions the study is for
Disruptive Behavior Disorder
What is being tested?
Strongest Families
Could I receive a placebo?
No, everyone receives an active treatment
How many people
464 participants
Where
1 siteFinland
Study dates
Oct 2011to Mar 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • - 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Finland1 site
  • University of Turku, Finland

    Turku

Other trials in Finland

About this study

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.

Read the 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.

Being tested
Strongest Families
Medical subject headings
Attention Deficit and Disruptive Behavior Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strongest FamiliesBehavioural

    Behavioural intervention

Study groups in NCT01750996
Study groupRoleWhat they receive
Usual Care control (Parenting tips)No interventionParticipants randomized to usual care will have access to a brief information website containing brief parenting tips but will not receive Strongest Families Intervention
Strongest FamiliesExperimentalStrongest Families intervention
Receives: Behavioral: Strongest Families

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CHild Behaviour Checklist (to measure change from baseline)

    Measure of child behavioural change from baseline to 6 \& 12 months

    Measured: Measure change from baseline at 6 & 12 months

Secondary outcomes (9)
  1. Depression Anxiety and Stress Scale Short Form (DASS-21)- Finnish

    Parental stress changes from baseline will be measured over time

    Measured: Baseline, 6 & 12months

  2. The Parenting Scale (To measure change from baseline to 6 & 21 months)

    Measure parental parenting practice changes from baseline

    Measured: To measure change from baseline to 6 & 12 months post randomization

  3. Barkley's Quick-Screen: The Barkley Adult ADHD Rating Scale IV (to measure change from baseline)

    To measure parental ADHD symptom changes form baseline

    Measured: Measure change from baseline to 6&12 months

  4. Child Behaviour Checklist- Teacher version (to measure change since baseline)

    To measure child behaviour changes at daycare from baseline to 6 \& 12 months post randomization

    Measured: Measure change from Baseline to 6 & 12 months

  5. Satisfaction measure: Researcher designed for the Intervention group

    To measure satisfaction with Intervention and website information

    Measured: end of program intervention (average is about 5 months but timing of completion varies between participants.)

  6. Strengths & Difficulties Questionnaire (Screening Tool)

    Screening tool used to identify high risk 4 year olds

    Measured: Screening

  7. The Parent Problem Checklist

    To measure interparental conflict

    Measured: Measure change from Baseline to 6 & 12 months

  8. The Sense of Coherence Scale (SOC-13)

    To measure parent's sense of coherence (i.e., global view of the world, and individual environment as comprehensible, manageable and meaningful)

    Measured: Measure change from Baseline to 6 & 12 months

  9. The Inventory of Callous-Unemotional Traits

    To measure child empathy

    Measured: Measure change from Baseline to 6 & 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2012 (estimated)
  2. Study startOct 2011
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
464 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01750996
Sponsor's protocol ID
CIHR# 103146
Acronym
Fin-Can
Status last verified
Sep 2016
First submitted
14 Nov 2011
Last updated
2 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Aggregate summary data would be made available but not individual data.

Publications

  • 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.

    PubMed 24139323
  • 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.

    PubMed 26913614
  • Rissanen E, Kuvaja-Kollner V, Kankaanpaa E. Cost-Effectiveness of Digital Preventive Parent Training for Early Childhood Disruptive Behaviour. J Ment Health Policy Econ. 2024 Sep 1;27(3):85-98.

    PubMed 39290059
  • 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.

    PubMed 35377332
  • 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.

    PubMed 30196869

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Strongest Families in people with Disruptive Behavior Disorder, run by IWK Health Centre at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CHild Behaviour Checklist (to measure change from baseline) (time frame: Measure change from baseline at 6 & 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01750996, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.

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