Clinical trial NCT02306551: Well Being And Resilience: Mechanisms of Transmission of Health and Risk
Official title: Well Being And Resilience: Mechanisms of Transmission of Health and Risk in Parents With Complex Mental Health Problems and Their Offspring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychotic Disorder
Bipolar Disorder
Depressive Disorder
Keywords: Offspring
Attachment
Risk development
Resilience
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: Psychiatric Research Unit, Psychiatry, Region Zealand, Denmark
name: Region of Southern Denmark
First posted: 2014-12-03
Enrollment: 93
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Infant attachment as measured by Strange Situation Procedure (Ainsworth et al. 1978)
timeFrame: At infant 52 weeks of age
Secondary outcomes:
measure: Infant neurobehavioral outcome as measured by Neonatal Intensive Care Unit Neurobehavioral Scale, NNNS, (Lester & Tronick, 2005)
timeFrame: 1-7 days and 4 weeks
measure: Infant development as measured by Bayley's scales for infant development 3rd edition (BSID-III-R, Bayley, 2006)
timeFrame: 16 and 52 weeks of infant age
measure: Infant stress exposure and physiological stress-sensitivity as measured by hair and salivary cortisol
timeFrame: 1-7 days (hair only) 4 (Saliva only), 16 and 52 weeks of infant age
measure: Infant social-interactive behavior as measured by Coding Interactive Behavior, CIB (Ruth Feldman, 2012)
timeFrame: 1-7 days, 4 and 16 weeks
Other outcomes:
measure: 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.
timeFrame: at baseline before birth of the child and at 1-7 days, 4, 16 and 52 weeks of infant age.
measure: 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
timeFrame: at baseline before birth of the infant
measure: Maternal stress-exposure and stress-sensitivity measured by hair and saliva cortisol
timeFrame: During pregnancy and at infant 16 and 52 weeks of age
measure: Parental attachment assessed by The Adult Attachment Interview (AAI, George, Kaplan & Main, 1987) (mothers only), The Adult Attachment Projective (AAP, George & West, 2012) and Psychosis Attachment Measure (PAM, Berry, Wearden & Barrowclough, 2006)
timeFrame: At baseline before birth of the infant
measure: Parental caregiving representation as assessed by Prenatal Care-giving Experiences Questionnaire (PCEQ, Brennan, George, & Solomon, 2013) Care-giving Experiences Questionnaire (CEQ, Brennan, George & Solomon, 2013)
timeFrame: at baseline (PCEQ), 1-7 days, 4,16 and 52 weeks (CEQ)
measure: Maternal caregiving behavior as assessed by AMBIANCE (Lyons-Ruth, Bronfmann, & Parson, (1999). Coding Interactive Behavior, CIB (Ruth Feldman, 2012)
timeFrame: 1-7 days, 4 weeks (CIB), 16 and 52 weeks (AMBIANCE)
measure: Paternal caregiving behavior as assessed by CIB
timeFrame: 16 weeks
measure: Paternal symptom severity as assessed by Brief Symptom Severity (BSI-53,Derogatis & Melisaratos, 1983)
timeFrame: At baseline before birth of the infant
measure: Parental diagnosis as assessed by Structured Clinical Interview for DSM-5 (SCID) psychosis module (mothers). Structured Assessment of Personality Abbreviated Scale (SAPAS, Moran et al 2003)
timeFrame: At baseline before birth of the infant
measure: Cognitive functioning as assessed by Reynolds Intellectual Screening Test (RIST, Reynolds, Kamphaus and Raines, 2012)
timeFrame: At baseline before birth of the infant
measure: Social functioning and support as assessed by Global Assessment of Functioning, GAF(DSM-IV). Significant Other Scale (SOS, Power, Chanpion & Aris)
timeFrame: At baseline and 4, 16 and 52 weeks
measure: Perceived stress as assessed by The Perceived Stress Scale (PSS)
timeFrame: At baseline and at 16 and 52 weeks
measure: Parenting Stress Index, 3rd Edition Short Form (PSI/SF)
timeFrame: At 16 weeks
measure: Parental Alliance Measure
timeFrame: At 16 weeks
measure: ASQ-SE
timeFrame: 52 weeks
Locations:
city: Odense
country: Denmark
facility: Department of child and adolescent mental health Odense, Research Unit, Mental Health Services in the Region of Southern Denmark
city: Roskilde
country: Denmark
facility: Psychiatric Research Unit, Psychiatry, Region Sealand, Institute of Clinical Medicin, Faculty of Health Sciences, University of Copenhagen
city: Glasgow
country: United Kingdom
facility: Institute of Health and Well being, University of Glasgow
Study officials:
affiliation: Department of Psychology, University of Copenhagen, Denmark
name: Susanne Harder, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Andrew Gumley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.