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.

TRIAL REGISTRATION DRKS-ID: DRKS00003500.