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Preventing Preschool Mental Health Problems: Population-Based Cluster Randomized Controlled Trial

Hiscock, Harriet, MBBS, MD*,†,‡; Gulenc, Alisha, BPsychSc (Hons)†,‡; Ukoumunne, Obioha, C., MSc, PhD§; Gold, Lisa, MA, MSc, PhD; Bayer, Jordana, MClin Psych, PhD*,†,‡,¶; Shaw, Daniel, PhD**; Le, Ha, MHEcon, MBA, Grad Dip PH; Wake, Melissa, MBChB, MD*,†,‡

Journal of Developmental & Behavioral Pediatrics: January 2018 - Volume 39 - Issue 1 - p 55–65
doi: 10.1097/DBP.0000000000000502
Original Articles

Objective: Prevention of child behavior problems may reduce later mental health problems. We compared the effectiveness, at the population level, of an efficacious targeted prevention program alone or following a universal parenting program.

Methods: Three-arm, cluster randomized controlled trial. One thousand three hundred fifty-three primary caregivers and healthy 8-month-old babies recruited from July 2010 to January 2011 from well-child centers (randomization unit). Primary outcome: Child Behavior Checklist (CBCL) externalizing and internalizing scales* at child ages 3 and 4.5 years. Secondary outcomes: Parenting Behavior Checklist* and over-involved/protective parenting (primary caregiver report). Secondary caregivers completed starred measures at age 3.

Results: Retention was 76% and 77% at ages 3 and 4.5 years, respectively. At 3 years, intention-to-treat analyses found no statistically significant differences (adjusted mean difference [95% confidence interval (CI); p-value]) for externalizing (targeted vs usual care −0.2 [−1.7 to 1.2; p = .76]; combined vs usual care 0.4 [−1.1 to 1.9; p = .60]) or internalizing behavior problems (targeted vs usual care 0.2 [−1.2 to 1.6; p = .76]; combined vs usual care 0.4 [−1.1 to 2.0; p = .58]). Primary outcomes were similar at 4.5 years. At 3 years, primary and secondary caregivers reported less over-involved/protective parenting in both the combined and targeted versus usual care arm; secondary caregivers also reported less harsh discipline in the combined and targeted versus usual care arm. Mean program costs per family were A$218 (targeted arm) and A$682 (combined arm).

Conclusion: When translated to the population level by existing staff, pre-existing programs seemed ineffective in improving child behavior, alone or in combination, but improved parenting.

*Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia;

Centre for Community Child Health, The Royal Children's Hospital, Melbourne, VIC, Australia;

Murdoch Childrens Research Institute, Melbourne, VIC, Australia;

§NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, Devon, United Kingdom;

Deakin Health Economics, Deakin University, Burwood, VIC, Australia;

School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia;

**Department of Psychology, University of Pittsburgh, Pittsburgh, PA.

Address for reprints: Harriet Hiscock, MBBS, MD, Centre for Community Child Health, The Royal Children's Hospital, Flemington Rd, Parkville, VIC 3052, Australia; e-mail: harriet.hiscock@rch.org.au.

This trial was funded by an Australian National Health and Medical Research Council (NHMRC) Partnership grant (#546525) and its community partners: The Victorian Department of Education and Early Childhood Development, the Victorian Department of Health and the Municipal Associations of Victoria. The researchers acknowledge support of the Australian NHMRC for salary support through Career Development Award 607351 (H.H.), Senior Research Fellowship 1046518 (M.W.), Early Career Fellowship 1035100 (L.G.), and Capacity Building Grants 425855 (L.G.) and 436914 (H.H. and J.B.). J. Bayer was funded by an Australian Rotary Health Postdoctoral Fellowship. Murdoch Childrens Research Institute research is supported by the Victorian Government's Operational Infrastructure Support Program. O. C. Ukoumunne is funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health in England.

Disclosure: The authors declare no conflict of interest.

Trial Registration: Controlled trials ISRCTN61137690 29th June 2010. URL: http://www.isrctn.com/.

Received April , 2017

Accepted July , 2017

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