Andre Sourander1, Patrick J McGrath2, Terja Ristkari3, Charles Cunningham4, Jukka Huttunen3, Patricia Lingley-Pottie5, Susanna Hinkka-Yli-Salomäki3, Malin Kinnunen3, Jenni Vuorio3, Atte Sinokki3, Sturla Fossum6, Anita Unruh7. 1. Department of Child Psychiatry, University of Turku, Turku, Finland2Turku University Hospital, Turku, Finland. 2. Centre for Research in Family Health, IWK Health Centre, Halifax, Nova Scotia, Canada4Faculty of Science, Dalhousie University, Halifax, Nova Scotia, Canada5Strongest Families Institute, Halifax, Nova Scotia, Canada6Department of Psychiatry, Dalhousie Uni. 3. Department of Child Psychiatry, University of Turku, Turku, Finland. 4. Department of Psychiatry and Behavioural Neurosciences, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada. 5. Centre for Research in Family Health, IWK Health Centre, Halifax, Nova Scotia, Canada5Strongest Families Institute, Halifax, Nova Scotia, Canada6Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada. 6. Center for Child and Adolescent Mental Health, North Norway, University of Tromsø, Breivika, Norway. 7. Faculty of Health Professions, Dalhousie University, Halifax, Nova Scotia, Canada.
Abstract
IMPORTANCE: There is a large gap worldwide in the provision of evidence-based early treatment of children with disruptive behavioral problems. OBJECTIVE: To determine whether an Internet-assisted intervention using whole-population screening that targets the most symptomatic 4-year-old children is effective at 6 and 12 months after the start of treatment. DESIGN, SETTING, AND PARTICIPANTS: This 2-parallel-group randomized clinical trial was performed from October 1, 2011, through November 30, 2013, at a primary health care clinic in Southwest Finland. Data analysis was performed from August 6, 2015, to December 11, 2015. Of a screened population of 4656 children, 730 met the screening criteria indicating a high level of disruptive behavioral problems. A total of 464 parents of 4-year-old children were randomized into the Strongest Families Smart Website (SFSW) intervention group (n = 232) or an education control (EC) group (n = 232). INTERVENTIONS: The SFSW intervention, an 11-session Internet-assisted parent training program that included weekly telephone coaching. MAIN OUTCOMES AND MEASURES: Child Behavior Checklist version for preschool children (CBCL/1.5-5) externalizing scale (primary outcome), other CBCL/1.5-5 scales and subscores, Parenting Scale, Inventory of Callous-Unemotional Traits, and the 21-item Depression, Anxiety, and Stress Scale. All data were analyzed by intention to treat and per protocol. The assessments were made before randomization and 6 and 12 months after randomization. RESULTS: Of the children randomized, 287 (61.9%) were male and 79 (17.1%) lived in other than a family with 2 biological parents. At 12-month follow-up, improvement in the SFSW intervention group was significantly greater compared with the control group on the following measures: CBCL/1.5-5 externalizing scale (effect size, 0.34; P < .001), internalizing scale (effect size, 0.35; P < .001), and total scores (effect size, 0.37; P < .001); 5 of 7 syndrome scales, including aggression (effect size, 0.36; P < .001), sleep (effect size, 0.24; P = .002), withdrawal (effect size, 0.25; P = .005), anxiety (effect size, 0.26; P = .003), and emotional problems (effect size, 0.31; P = .001); Inventory of Callous-Unemotional Traits callousness scores (effect size, 0.19; P = .03); and self-reported parenting skills (effect size, 0.53; P < .001). CONCLUSIONS AND RELEVANCE: The study reveals the effectiveness and feasibility of an Internet-assisted parent training intervention offered for parents of preschool children with disruptive behavioral problems screened from the whole population. The strategy of population-based screening of children at an early age to offering parent training using digital technology and telephone coaching is a promising public health strategy for providing early intervention for a variety of child mental health problems. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01750996.
RCT Entities:
IMPORTANCE: There is a large gap worldwide in the provision of evidence-based early treatment of children with disruptive behavioral problems. OBJECTIVE: To determine whether an Internet-assisted intervention using whole-population screening that targets the most symptomatic 4-year-old children is effective at 6 and 12 months after the start of treatment. DESIGN, SETTING, AND PARTICIPANTS: This 2-parallel-group randomized clinical trial was performed from October 1, 2011, through November 30, 2013, at a primary health care clinic in Southwest Finland. Data analysis was performed from August 6, 2015, to December 11, 2015. Of a screened population of 4656 children, 730 met the screening criteria indicating a high level of disruptive behavioral problems. A total of 464 parents of 4-year-old children were randomized into the Strongest Families Smart Website (SFSW) intervention group (n = 232) or an education control (EC) group (n = 232). INTERVENTIONS: The SFSW intervention, an 11-session Internet-assisted parent training program that included weekly telephone coaching. MAIN OUTCOMES AND MEASURES: Child Behavior Checklist version for preschool children (CBCL/1.5-5) externalizing scale (primary outcome), other CBCL/1.5-5 scales and subscores, Parenting Scale, Inventory of Callous-Unemotional Traits, and the 21-item Depression, Anxiety, and Stress Scale. All data were analyzed by intention to treat and per protocol. The assessments were made before randomization and 6 and 12 months after randomization. RESULTS: Of the children randomized, 287 (61.9%) were male and 79 (17.1%) lived in other than a family with 2 biological parents. At 12-month follow-up, improvement in the SFSW intervention group was significantly greater compared with the control group on the following measures: CBCL/1.5-5 externalizing scale (effect size, 0.34; P < .001), internalizing scale (effect size, 0.35; P < .001), and total scores (effect size, 0.37; P < .001); 5 of 7 syndrome scales, including aggression (effect size, 0.36; P < .001), sleep (effect size, 0.24; P = .002), withdrawal (effect size, 0.25; P = .005), anxiety (effect size, 0.26; P = .003), and emotional problems (effect size, 0.31; P = .001); Inventory of Callous-Unemotional Traits callousness scores (effect size, 0.19; P = .03); and self-reported parenting skills (effect size, 0.53; P < .001). CONCLUSIONS AND RELEVANCE: The study reveals the effectiveness and feasibility of an Internet-assisted parent training intervention offered for parents of preschool children with disruptive behavioral problems screened from the whole population. The strategy of population-based screening of children at an early age to offering parent training using digital technology and telephone coaching is a promising public health strategy for providing early intervention for a variety of child mental health problems. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01750996.
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