Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
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: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Oppositional Defiant Disorder
Behaviour Disorder
Behavioral: Strongest Families Intervention (formerly Family Help)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]
    Results will be analyzed as change from baseline over time


Estimated Enrollment: 300
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strongest Families Intervention + usual care services
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.
Behavioral: Strongest Families Intervention (formerly Family Help)
Distance HEALTH education intervention focussed on skill learning for parents
Other Name: formerly the Family Help Program
No Intervention: No Strongest Families Intervention
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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 (see above for T-scores and scales) 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473511

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Patrick J McGrath, PhD Vice President of REsearch Services
  More Information

Publications:

Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT01473511     History of Changes
Other Study ID Numbers: 4839, MCT-91030
Study First Received: July 22, 2011
Last Updated: September 15, 2014
Health Authority: Canada: Ethics Reveiw Committee

Keywords provided by IWK Health Centre:
Behavioural intervention
Distance intervention
Parenting intervention

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014