Clinical trial NCT01473511: Strongest Families Ontario (Formerly the Family Help Program)
Official title: Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oppositional Defiant Disorder
Behaviour Disorder
Keywords: Behavioural intervention
Distance intervention
Parenting intervention
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-11-17
Enrollment: 172
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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 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)

Primary outcomes:
measure: Child Behaviour Checklist
timeFrame: Baseline, 5, 10, 16, 22 months
Secondary outcomes:
measure: Alabama Parenting questionnaire
timeFrame: Baseline, 5, 10, 16, 22 months
measure: SCAPI (economic)
timeFrame: Baseline,5, 10, 16, 22
measure: DASS-21
timeFrame: Baseline,5, 10, 16, 22
measure: Investigator designed Satisfaction measure
timeFrame: end of intervention
measure: Investigator designed disability measure
timeFrame: weekly during intervention
measure: Discrete Conjoint Preference survey: Investigator designed
timeFrame: baseline, 5, 16 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: Vice President of REsearch Services
name: Patrick J McGrath, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690.
citation: Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001.
citation: Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25.
citation: Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101.
citation: Lingley-Pottie P, McGrath PJ. Development and initial validation of the treatment barrier index scale: a content validity study. ANS Adv Nurs Sci. 2011 Apr-Jun;34(2):151-62. doi: 10.1097/ANS.0b013e3182186cc0.
citation: McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.
citation: McGrath PJ, Lingley-Pottie P, Thurston C, MacLean C, Cunningham C, Waschbusch DA, Watters C, Stewart S, Bagnell A, Santor D, Chaplin W. Telephone-based mental health interventions for child disruptive behavior or anxiety disorders: randomized trials and overall analysis. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1162-72. doi: 10.1016/j.jaac.2011.07.013. Epub 2011 Sep 3.
citation: Lingley-Pottie P, Janz T, McGrath PJ, Cunningham C, MacLean C. Outcome progress letter types: parent and physician preferences for letters from pediatric mental health services. Can Fam Physician. 2011 Dec;57(12):e473-81.
citation: Lingley-Pottie P, McGrath PJ, Andreou P. Barriers to mental health care: perceived delivery system differences. ANS Adv Nurs Sci. 2013 Jan-Mar;36(1):51-61. doi: 10.1097/ANS.0b013e31828077eb.