Evaluation of two prevention programs `Early Steps' and `Faustlos' in daycare centers with children at risk: the study protocol of a cluster randomized controlled trial

Background: While early programs to prevent aggression and violence
are widely used, only a few controlled trials of effectiveness of
psychoanalytically based prevention programs for preschoolers have
been evaluated. This study compares `Faustlos' (a violence
prevention program) and `Early Steps' (a psychoanalytically based,
whole daycare center intervention to prevent violence) in daycare
centers in socioeconomically deprived neighborhoods.
Methods/Design: Preschoolers in 14 daycare centers in Frankfurt,
Germany, participate in a cluster randomized controlled trial
(CRCT). The daycare centers were randomly chosen from a
representative baseline survey of all Frankfurt's daycare centers
carried out in 2003 (n = 5,300) with the following stratifying
factors: children's aggressiveness, hyperactivity, anxiety and
socioeconomic status. Additionally, the geographic identification
of socioeconomically deprived neighborhoods regarding low-income
children was taken from the Frankfurt Municipality Statistics.
Children's attachment classification and children's aggressiveness,
hyperactivity, anxiety and social competence are measured as
outcome criteria before and after 2 years of intervention. The
programs in the study aim to reach a high-risk population.
Therefore, the combination of a random sampling of daycare centers
out of a representative baseline survey in all daycare centers in
Frankfurt and the application of official data on the local
distribution of low-income children are unique features offered by
the EVA study design. Data on preschooler's attachment
representations are collected in socioeconomically deprived
neighborhoods for the first time.