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Completed

NCT Number: NCT01473511

Strongest Families Ontario (Formerly the Family Help Program)

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Strongest Families Intervention (formerly Family Help)

Behavioral

Distance HEALTH education intervention focussed on skill learning for parents

Other names: formerly the Family Help Program

Primary outcomes

  1. Child Behaviour Checklist

    Time frame: Baseline, 5, 10, 16, 22 months

    Results will be analyzed as change from baseline over time

Secondary outcomes

  1. Alabama Parenting questionnaire

    Time frame: Baseline, 5, 10, 16, 22 months

    Results will be analyzed as change from baseline over time

  2. SCAPI (economic)

    Time frame: Baseline,5, 10, 16, 22

    Results will be analyzed as change from baseline over time

  3. DASS-21

    Time frame: Baseline,5, 10, 16, 22

    Results will be analyzed as change from baseline over time

  4. Investigator designed Satisfaction measure

    Time frame: end of intervention

    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

  5. Investigator designed disability measure

    Time frame: weekly during intervention

    Results will be analyzed as change from baseline over time

  6. Discrete Conjoint Preference survey: Investigator designed

    Time frame: baseline, 5, 16 months

    We will examine if discrete choice data collected at baseline predicts participation, adherence and outcome. We will also explore changes in preferences over time.

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario

Acronym: SF-ON

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2011
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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