Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003500

Trial Description

start of 1:1-Block title

Title

Evaluation of two prevention programs "EARLY STEPS" and "FISTLESS" in day-care centers with children at risk - a follow-up project to the Frankfurt Prevention Study within the framework of the Reseach Center „Individual Development and Adaptive Education“ (IDeA)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

EVA

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.idea-frankfurt.eu/homepage/idea-projects/projekt-eva

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

As many studies in the fields of empirical infant research, relationship research and psychoanalysis demonstrate, the experience of stable emotional relationships in the first years of one's life is the best precondition for a successful psychical, cognitive and psychosocial development, including the acquisition of language. Numerous prevention programs follow these empirical findings and try to support children already at the kindergarten age; yet such offers do not reach all families, as families with a migration background are, for instance, unaware of such programs. The early prevention of violence, social learning and the support of the social integration of children from these societal groups were therefore the aims of the Frankfurt prevention study, which was conducted by the Sigmund-Freud-Institut in cooperation with the Institut für Analytische Kinder- und Jugendlichenpsychotherapie and the municipal education authority in 14 day-care centers in Frankfurt from 2003 to 2006. The study was based on clinical experiences and new findings in psychoanalytical developmental psychology, early education and brain science according to which the early years of life set the course for future psychical and psychosocial developments. Against this backdrop, the findings of the representative study were of great significance: the aggression and fearfulness of children as well as the hyperactivity of girls showed a statistically significant reduction in comparison to the control group.

Conducted by the Sigmund-Freud-Institut in Frankfurt am Main, the follow-up project to the Frankfurt prevention study, EVA, is now meant to review the differential effects of two established prevention programs – „FISTLESS“ and „EARLY STEPS“. Both prevention projects run in seven day-care centers selected because of their interest in conducting these projects.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Given that the experience of stable emotional relationships in the first years of one's life is the best precondition for a successful psychical, cognitive and psychosocial development numerous prevention programs try to intervene very early and support children already at the kindergarten age; yet such offers very often do not reach all families or they do not meet the specific needs of the families.

In the EVA research project we intent to intervene very early in order to disrupt adverse developments in the very special population, namely children aged 3 to 5, who are strained by different risk factors such as migration background, poor socioeconomic status etc. We therefore installed two different prevention programs in problematic urban districts in Frankfurt/Main in order to compare their effecttiveness in preventing social-emotional or psychic disturbances in children.

From a scientific point of view one of our major aims is to evaluate these two early prevention programs and their effectiveness. The hypothesis is, that a program like „EARLY STEPS“ which tries to individually address the specific needs of the child, that such a program is more effective given these risk populations than a more general curriculum like „FISTLESS“. On the other hand, in some day-care centers the more narrow approach of „FISTLESS“ might better meet the teachers‘ demand for structure – so what we are also interested in, is to investigate the effectiveness of the prevention program in relation to its actual „goodness of fit“ to the needs of the institution.

One approach to tap the specific mother-child-interrelation and the child‘s inner object representations is the attachment approach. That is why we want to investigate the programs‘ influence on the attachment. We assume that by offering good and stable alternative relational experiences and by working on the parent-child relationship within the „EARLY STEPS“ program, we might manage to change the attachment type of some children from an unsecure or desorganized to a more secure attachment.

Design of the EVA-study:
In EVA we realize a longitudinal cluster randomized trial design with pre-, post- and follow-up measurement time points. The clusters, respectively the day care-centers were randomly chosen on basis of a representative baseline survey of all Frankfurt day-care centers carried out in 2003. In this baseline survey relevant characteristics of more than 5300 children, namely their levels of hyperactivity, aggression and anxiety were measured. Additionally, statistical socioeconomical indicators of the City of Frankfurt/Main were included.

Regarding the institutional framework:
The IDeA (Center for Research on Individual Development and Adaptive Education of Children at Risk) was founded by the German Institute for International Educational Research (DIPF) and Goethe Universität Frankfurt in cooperation with the Sigmund-Freud-Institute (SFI).
IDeA is an interdisciplinary research center which is financed by the LOEWE iniative of the State Hessen, Germany, a huge promotional program fostering excellent research in Hessen.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003500
  •   2012/02/14
  •   [---]*
  •   yes
  •   Approved
  •   [---]*, Landeskammer für Psychotherapeutinnen und -therapeuten und Kinder- und Jugendlichenpsychotherapeutinnen und -therapeuten Hessen (LPPKJP Hessen)
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Attachment representation/ attachment strategy of the child
  •   F91 -  Conduct disorders
  •   F90 -  Hyperkinetic disorders
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   A two years psychoanalytical early prevention program „EARLY STEPS“ (Leuzinger-Bohleber et al., 2007) in seven day-care centers:

    This prevention program is characterized by its approach as it starts from a detailed understanding of an individual child and its family. Each child is unique, as is each family. Therefore, support is then most helpful when the specific skills and resources of the individual child are taken as the starting point. Hence, child behavior is not seen primarily as „dysfunctional behavior“ but rather as the expression of a hidden (unconscious), reasonable, mental event. Thus, the specific and perhaps eye-catching „behavior“ of a child needs first to be deciphered and should not be passed over as quickly as possible. hea im of supportive measures is to allow the child to come to more positive experiences of itself and its attachment figures and to develop its talents in an optimal way.

    „EARLY STEPS“ consists of different elements:
    14-day case supervision of the day-care center team,
    weekly offer of counseling and training for educators and parents in the day-care center by experienced psychoanalytical child and adolescent psychotherapists.
    In individual cases, the offer of therapy for children and their parents in the facilities
    „FISTLESS“ violence prevention program at the earliest in the second year of the project
    If required, individual mentoring of children by student teachers in their transition from kindergarten to primary school.

    „EARLY STEPS“ is conducted in close cooperation with the Institut für Analytische Kinder- und Jugendlichenpsychotherapie.

    Duration of intervention: two years

  •   A violence prevention program "FISTLESS" (Cierpka & Schick, 2006) in seven day-care centers:

    The violence prevention program "FISTLESS" is now a widely used, scientifically well-founded program developed by a research group around Manfred Cierpka in Heidelberg (cf. inter alia Cierpka & Schick, 2006). The program is based on the US-prevention program "SECOND STEP" (Committee for Children; Fitzgerald & Estrom, 2006). It consists of the so-called "FISTLESS-case", which carries materials that can be used by educators in different "lessons" after they have received training lasting about one year. These lessons are described in detail in an introductory handbook.
    The emphasis of the program is on the self-perception and the perception by others of emotions and thoughts in social interaction. With the help of images of different emotional states, the cognition of mimic and corporeal "messages" of other children and oneself is trained. Images portray different conflict situations, which are discussed and re-enacted in role-play.
    Duration of intervention: two years
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
  •   [---]*
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

“Manchester Child Attachment Story Task” (MCAST) (Green, Stanley, Smith, & Goldwyn, 2000): In the MCAST, using a standardised doll-play completion task, which was developed by the research group around Jonathan Green, the examiner plays various attachment relevant stress situations, which are videotaped. Afterwards, the video material is analysed with respect to thirty-three attachment specific characteristics. The MCAST provides information about the child's attachment representations towards their caregiver. Four different attachment strategies can be distinguished: B - secure strategy, A - insecure avoidant strategy, C - insecure ambivalent and D - Disorganisation.
Measurement time points: before and after intervention.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

„Hannover-Wechsler intelligence test for the preschool age“ (HAWIVA –III, Ricken et al., 2007);
„Strengths and Difficulties Questionnaire“ (SDQ) with following scales: prosocial behaviour, hyperactivity, emotional symptoms, peer relationships, conduct problems (Goodman, 1997; Woerner et al., 2002) from the teacher’s and parent’s perspective;
observational instrument for teachers „Positive Development and Resilience in Day-Care Centers’ Daily Routine“ (PERIK) (Mayr & Ulich, 2009), a tool for observation and evaluation of the emotional well-being of preschool children;
„Caregiver-Teacher Report Form“ (C-TRF) (Achenbach & Rescorla, 2000);
parent interview capturing risk factors (Neubert & Laezer, 2011);
"Reflective Self Functioning Scale" (Fonagy et al. 1998, Daudert, 2001, 2002).

Measurement time points: before and after intervention.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2009/02/25
  •   280
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   5   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

All children fitting the age range in the research day-care centers

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

All children beyond the age range in the research day-care centers

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Sigmund-Freud-Institut.
    • Ms.  Prof. Dr.  Marianne  Leuzinger-Bohleber 
    • c/o J.W. Goethe-Universität Frankfurt am Main Mertonstr. 17/ Hauspostfach 55
    • D-60325  Frankfurt am Main
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Sigmund-Freud-Institut
    • Ms.  Dr.  Katrin Luise  Läzer 
    • c/o J.W. Goethe-Universität Frankfurt am Main Mertonstr. 17/ Hauspostfach 55
    • D-60325  Frankfurt am Main
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Sigmund-Freud-Institut
    • Ms.  Dr.  Katrin Luise  Läzer 
    • c/o J.W. Goethe-Universität Frankfurt am Main Mertonstr. 17/ Hauspostfach 55
    • D-60325  Frankfurt am Main
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Forschungszentrum "Individuelle Entwicklung und Lernförderung" (IDeA), gefördert durch Landes-Offensive zur Entwicklung Wissenschaftlich-ökonomischer Exzellenz (LOEWE)
    • Schloßstraße 29
    • 60486  Frankfurt am Main
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Sigmund-Freud-Institut Frankfurt. Forschungsinstitut für Psychoanalyse und ihre Anwendungen
    • 60325  Frankfurt am Main
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
  • start of 1:1-Block address otherSupport
    • Institut für analytische Kinder- und Jugendlichenpsychotherapie in Hessen e.V.
    • 60325  Frankfurt am Main
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.