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

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.