Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004649

Trial Description

start of 1:1-Block title

Title

Multicentric investigation of behavioral and neuronal influences of adverse childhood experiences on mother-child interaction

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

Trial Acronym

UBICA

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

Mothers with a history of adverse experiences often display dysfunctional patterns when interacting with their own children compared to mothers without these experiences. Such intergenerational transmission of adverse experiences has been observed by clinicians and other health professionals. It is assumed that, in such case, the parenting abilities are fundamentally disturbed, because these mothers have experienced physical and sexual abuse or neglect mainly by their own caregivers. Further investigation of the transmission of abuse is needed to understand its underlying mechanisms and to design successful intervention and prevention programs.
The present project not only seeks to understand this so-called “cycle of abuse” but aims at evaluating therapeutic interventions to break this vicious circle.
In this multi-center study, mothers with a history of sexual of physical abuse in childhood together with their children in middle childhood (5-12 years) will be included. The project focuses on the mothers’ and their children’s mental health as well as on mother-child interactions. In the study, different methods will be used: We will observe behavior, conduct psychological tests, and provide questionnaires. Furthermore, hormonal levels (i.e., the stress hormone cortisol) will be assessed, genetic and epigenetic analyses will be conducted, and the mothers’ brains will be looked at (by) using brain-imaging techniques (fMRI).
A further goal of the study is to find intervention programs that can improve mother-child interactions. 120 mother-child dyads with and 120 dyads without a history of adverse life events will take part in a baseline diagnostic investigation. After this, 120 mothers with a history of adverse life events (60 mothers of the Heidelberg subproject and 60 mothers of the Berlin subproject) and their children will be randomized to either a Parent-Child-Interaction-Therapy (PCIT) or dose-matched individual stress management training for mothers (each comprised of 12 weekly sessions). While the Parent-Child-Interaction-Therapy includes coaching of the mother with respect to the mother-child interaction, the second intervention program, a stress-management training, improves maternal stress coping strategies. The intervention groups will be compared regarding maternal sensitivity, maternal abuse potential, child mental health, and quality of life immediately after the intervention and 6 months later.

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

Brief Summary in Scientific Language

Given the high prevalence of mothers with a history of adverse experiences who show dysfunctional patterns in the interaction with their own children, a better understanding of the intergenerational transmission of abuse is urgently needed. Moreover, it is of crucial importance to evaluate effective interventions to stop this vicious cycle. The aim of the study is to investigate dysfunctional interactions of traumatized mother-child dyads by combining basic neurobiological research with randomized controlled intervention trials. The project focuses on the dyadic interaction by investigating (1) the behavioural and (neuro)biological correlates of maternal sensitivity, affect regulation and child abuse potential, i.e. neural mechanisms, hormones and (epi-)genetics and (2) the impact of maternal behaviour and characteristics on her child’s well-being including its emotional and cognitive development.
This multicentre study includes mothers with and without a history of physical or sexual abuse in their own childhood and their 5-to 12-year old children. 120 mother-child dyads with a history of maternal abuse and non-optimal maternal sensitivity will be included in a randomized therapy study (N=60 in Heidelberg and N=60 in Berlin). The aim of this randomized control trial is to compare the effectiveness of an intervention program with a specific focus on mother-child interaction (parent-child-interaction-therapy, PCIT) with a non-dyadic treatment (maternal stress management training). More precisely, the intervention groups will be compared regarding maternal sensitivity, maternal abuse potential, child mental health and quality of life immediately after the intervention and 6 months later.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004649
  •   2013/01/31
  •   [---]*
  •   yes
  •   Approved
  •   S134/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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

  •   Sexual or physical childhood abuse
  •   T74.1 -  Physical abuse
  •   T74.2 -  Sexual abuse
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Parent-Child-Interaction-Therapy (Hembree-Kigin et al., 1995): 1 50min session/week; 12 sessions; participation at at least 8 sessions required
  •   Individual Stress Management Training (modified after Kaluza, 2011): 1 50min session/week; 12 sessions; participation at at least 8 sessions required
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Mother: Changes in maternal sensitivity from baseline to follow-up I (after intervention) (EA-score). Child: Changes in the child's well-being from baseline to follow-up I (after intervention) (KIDS-SCREEN-score).

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

Secondary Outcome

Mother: Changes in maternal sensitivity, Intrusivity and hostility from baseline to follow-up II (6 months after intervention) in EA-scores as well as changes in maternal psychopathology from baseline to follow-up I (after intervention) and II (6 months after intervention) (HAMD, SCL-90-R, BDI-II, IRI, PSI, scores) and in maternal abuse risk (EBSK, score). Child: Changes in the child's responsiveness (EA-scales) and the child's well-being (KIDS-SCREEN score) from baseline to follow-up II (6 months after intervention) as well as changes in the child's behavior from baseline to follow-up I (after intervention) and II (6 months after intervention) (CBCL, TRF, scores).

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

  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/01/01
  •   240
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Mothers with and without adverse childhood experiences and with 5-12 years old children

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

Exclusion Criteria

Participants with contraindications against MRI will be excluded from the study. Participants with claustrophobia, acute suicidality or drug dependency will be also excluded. In addition, control-dyads must not have any traumatic childhood experiences.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Allgemeine Psychiatrie Universitätsklinikum Heidelberg
    • Ms.  Prof. Dr.  Sabine  Herpertz 
    • Voßstr. 4
    • 69115  Heidelberg
    • 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 other
    • Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters Charité Campus Virchow Klinikum
    • Ms.  Dr. phil.  Katja  Bödeker 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für Allgemeine Psychiatrie Universitätsklinikum Heidelberg
    • Ms.  Prof. Dr. med.  Sabine  Herpertz 
    • Voßstraße 4
    • 69115  Heidelberg
    • 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
    • Psychiatrische Universitätsklinik der Charité im St. Hedwig-Krankenhaus
    • Mr.  Prof. Dr.  Felix  Bermpohl 
    • Große Hamburger Str. 5-11
    • 10115  Berlin
    • 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
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/05/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Maternal sensitivity and the empathic brain: Influences of early life maltreatment. Mielke EL, Neukel C, Bertsch K, Reck C, Möhler E, Herpertz SC. J Psychiatr Res. 2016 Jun;77:59-66. doi: 10.1016/j.jpsychires.2016.02.013. Epub 2016 Feb 23.
  •   EMOTIONAL AVAILABILITY IN MOTHER-CHILD INTERACTION: THE EFFECTS OF MATERNAL DEPRESSION IN REMISSION AND ADDITIONAL HISTORY OF CHILDHOOD ABUSE. Kluczniok D, Boedeker K, Fuchs A, Hindi Attar C, Fydrich T, Fuehrer D, Dittrich K, Reck C, Winter S, Heinz A, Herpertz SC, Brunner R, Bermpohl F. Depress Anxiety. 2015 Dec 23. doi: 10.1002/da.22462. [Epub ahead of print]
  •   Transgenerational effects of maternal depression on affect recognition in children. Kluczniok D, Hindi Attar C, Fydrich T, Fuehrer D, Jaite C, Domes G, Winter S, Herpertz SC, Brunner R, Boedeker K, Bermpohl F. J Affect Disord. 2016 Jan 1;189:233-9. doi: 10.1016/j.jad.2015.09.051. Epub 2015 Oct 8.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.