Well Being And Resilience: Mechanisms of Transmission of Health and Risk

NCT ID: NCT02306551

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-09-30

Brief Summary

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The purpose of this study is to establish a cohort of pregnant women with severe mental disorder and to identify biological and psycho-social transmission mechanisms involved in the development of 'risk' and 'resilience' in the offspring. It is assumed that both 'resilient' and 'risk' development in offspring are caused by a complex interaction between multiple biological, psychological and social factors. The project focuses specifically on exploring the impact of physiological stress-sensitivity, attachment, care-giving and the familial and social context for care-giving. Previous studies support these factors as important for the development of these infants, but systematic research using a prospective design is needed to strengthen evidence and elucidate the importance of these factors in more detail. The interaction over time of physiological stress-sensitivity, attachment, care-giving and the familial and social context for care-giving are evaluated in terms of the evolution of very early indicators of developmental risk and resilience in infants with a known highly increased risk for developing a mental disorder.The findings of the study may potentially lead to more specific targets for preventive interventions, which can improve developmental outcome for these infants.

Detailed Description

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Conditions

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Psychotic Disorder Bipolar Disorder Depressive Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Psychotic Disorder

Biological and psycho-social risk and resilience factors

Biological and psycho-social risk and resilience factors

Intervention Type OTHER

Naturalistic study, no active intervention or exposure is administered

Bipolar Disorder

Biological and psycho-social risk and resilience factors

Biological and psycho-social risk and resilience factors

Intervention Type OTHER

Naturalistic study, no active intervention or exposure is administered

Depressive Disorder

Biological and psycho-social risk and resilience factors

Biological and psycho-social risk and resilience factors

Intervention Type OTHER

Naturalistic study, no active intervention or exposure is administered

Non-psychiatric Control

Biological and psycho-social risk and resilience factors

Biological and psycho-social risk and resilience factors

Intervention Type OTHER

Naturalistic study, no active intervention or exposure is administered

Interventions

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Biological and psycho-social risk and resilience factors

Naturalistic study, no active intervention or exposure is administered

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with Psychotic Disorder (DSM-5: Delusional Disorder (297.1)
* Schizophreniform Disorder (295.4), Schizophrenia (295.90), Schizoaffective Disorder (295.70)
* Brief Psychotic Disorder (298.8) Other specified schizophrenia spectrum and other psychotic disorder (298.8), Unspecified schizophrenia spectrum and other psychotic disorder (298.9) )
* Lifetime diagnosis of DSM-5 Bipolar I and II Disorder (296.89)
* Diagnosis of DSM-5 Major Depressive Disorder current single episode (current 296.22 - 296.25) or recurrent episode (296.32 - 296.35)
* Non-psychiatric control group defined as mothers without any history of treatment or admission for a psychiatric disorder or drug or alcohol addiction.
* Partners of participating women with an expected care-giving role in relation to the infant will also be eligible for participation in the study.
* Infants of participating pregnant women will be included from birth.

Exclusion Criteria

* Unable to provide informed consent to participate
* Unable to speak English or Danish because of the requirement to complete assessments,
* Miscarriage.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Glasgow

OTHER

Sponsor Role collaborator

Psychiatric Research Unit, Psychiatry, Region Zealand, Denmark

UNKNOWN

Sponsor Role collaborator

Region of Southern Denmark

OTHER

Sponsor Role collaborator

Susanne Harder

OTHER

Sponsor Role lead

Responsible Party

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Susanne Harder

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Susanne Harder, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, University of Copenhagen, Denmark

Andrew Gumley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

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Department of child and adolescent mental health Odense, Research Unit, Mental Health Services in the Region of Southern Denmark

Odense, , Denmark

Site Status

Psychiatric Research Unit, Psychiatry, Region Sealand, Institute of Clinical Medicin, Faculty of Health Sciences, University of Copenhagen

Roskilde, , Denmark

Site Status

Institute of Health and Well being, University of Glasgow

Glasgow, , United Kingdom

Site Status

Countries

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Denmark United Kingdom

References

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Stender S, Davidsen KA, Lyons-Ruth K, Harder S. Disinhibited attachment behavior among infants reared at home: Relations to maternal severe mental illness and personality disorder symptoms. Personal Disord. 2024 May;15(3):207-212. doi: 10.1037/per0000653. Epub 2024 Feb 8.

Reference Type DERIVED
PMID: 38330355 (View on PubMed)

Harder S, Davidsen K, MacBeth A, Lange T, Minnis H, Andersen MS, Simonsen E, Lundy JM, Nystrom-Hansen M, Trier CH, Rohder K, Gumley A. Wellbeing and resilience: mechanisms of transmission of health and risk in parents with complex mental health problems and their offspring--The WARM Study. BMC Psychiatry. 2015 Dec 9;15:310. doi: 10.1186/s12888-015-0692-6.

Reference Type DERIVED
PMID: 26654720 (View on PubMed)

Other Identifiers

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DFF-1319-00103

Identifier Type: -

Identifier Source: org_study_id

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