NCT02306551

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

5.9 years

First QC Date

November 12, 2014

Last Update Submit

January 20, 2023

Conditions

Psychotic DisorderBipolar DisorderDepressive Disorder

Keywords

OffspringAttachmentRisk developmentResilience

Outcome Measures

Primary Outcomes (1)

  • Infant attachment as measured by Strange Situation Procedure (Ainsworth et al. 1978)

    Strange Situation Procedure is a structured observation. The infant is videotaped in a playroom during a series of eight structured 3-min episodes involving the baby, the mother, and a female stranger. During the observation the mother leaves and rejoins the infant twice, first leaving the infant with the female stranger, then leaving the infant alone to be rejoined by the stranger. The procedure is designed to be mildly stressful in order to increase the intensity of activation of the infant's attachment behavior. Videotapes are coded for four attachment classifications: secure, avoidant, ambivalent-resistant/dependent and disorganised.

    At infant 52 weeks of age

Secondary Outcomes (4)

  • Infant neurobehavioral outcome as measured by Neonatal Intensive Care Unit Neurobehavioral Scale, NNNS, (Lester & Tronick, 2005)

    1-7 days and 4 weeks

  • Infant development as measured by Bayley's scales for infant development 3rd edition (BSID-III-R, Bayley, 2006)

    16 and 52 weeks of infant age

  • Infant stress exposure and physiological stress-sensitivity as measured by hair and salivary cortisol

    1-7 days (hair only) 4 (Saliva only), 16 and 52 weeks of infant age

  • Infant social-interactive behavior as measured by Coding Interactive Behavior, CIB (Ruth Feldman, 2012)

    1-7 days, 4 and 16 weeks

Other Outcomes (15)

  • Maternal symptom severity as measured by Positive and Negative Syndrome Scale, PANSS, Kay et al.1989, The Montgomery Asberg Depression Rating Scale, MADRS, Montgomery and Asberg, 1979. The Bech-Rafaelsen Mania Rating Scale, BRMRS, Bech et al. 1979.

    at baseline before birth of the child and at 1-7 days, 4, 16 and 52 weeks of infant age.

  • Parental social risk status as measured by Adverse Childhood Experiences Study Questionnaires (ACES) (Felitti et al., 1998) (trauma, mothers only), work status and level of education

    at baseline before birth of the infant

  • Maternal stress-exposure and stress-sensitivity measured by hair and saliva cortisol

    During pregnancy and at infant 16 and 52 weeks of age

  • +12 more other outcomes

Study Arms (4)

Psychotic Disorder

Biological and psycho-social risk and resilience factors

Other: Biological and psycho-social risk and resilience factors

Bipolar Disorder

Biological and psycho-social risk and resilience factors

Other: Biological and psycho-social risk and resilience factors

Depressive Disorder

Biological and psycho-social risk and resilience factors

Other: Biological and psycho-social risk and resilience factors

Non-psychiatric Control

Biological and psycho-social risk and resilience factors

Other: Biological and psycho-social risk and resilience factors

Interventions

Biological and psycho-social risk and resilience factorsOTHER

Naturalistic study, no active intervention or exposure is administered

Bipolar DisorderDepressive DisorderNon-psychiatric ControlPsychotic Disorder

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women referred to maternity services or psychiatric services in Denmark in Region Zealand and Region Southern Denmark, in Scotland from NHS Greater Glasgow and Clyde

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to provide informed consent to participate
  • Unable to speak English or Danish because of the requirement to complete assessments,
  • Miscarriage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Odense, 5000, Denmark

Location

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

Roskilde, 4000, Denmark

Location

Institute of Health and Well being, University of Glasgow

Glasgow, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 38330355DERIVED

  • 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.

    PMID: 26654720DERIVED

MeSH Terms

Conditions

Psychotic DisordersBipolar DisorderDepressive Disorder

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

  • Susanne Harder, PhD

    Department of Psychology, University of Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

  • Andrew Gumley, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2014

First Posted

December 3, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2020

Study Completion

September 1, 2021

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

DK(2)GB(1)