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

Study Overview
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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.

Official Title
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Well Being And Resilience: Mechanisms of Transmission of Health and Risk in Parents With Complex Mental Health Problems and Their Offspring

Conditions
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Psychotic Disorder, Bipolar Disorder, Depressive Disorder

Intervention / Treatment
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* Other: Biological and psycho-social risk and resilience factors


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psychotic Disorder<br>Biological and psycho-social risk and resilience factors | Other: Biological and psycho-social risk and resilience factors<br>* Naturalistic study, no active intervention or exposure is administered<br>|
| Bipolar Disorder<br>Biological and psycho-social risk and resilience factors | Other: Biological and psycho-social risk and resilience factors<br>* Naturalistic study, no active intervention or exposure is administered<br>|
| Depressive Disorder<br>Biological and psycho-social risk and resilience factors | Other: Biological and psycho-social risk and resilience factors<br>* Naturalistic study, no active intervention or exposure is administered<br>|
| Non-psychiatric Control<br>Biological and psycho-social risk and resilience factors | Other: Biological and psycho-social risk and resilience factors<br>* Naturalistic study, no active intervention or exposure is administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant neurobehavioral outcome as measured by Neonatal Intensive Care Unit Neurobehavioral Scale, NNNS, (Lester & Tronick, 2005) | NNNS is a 30-minute, 128-item assessment of neurologic, behavioural, and stress/abstinence signs that evaluates the full range of infant neurobehavior. It has 12 summary scales: habituation, attention, arousal, regulation, number of handling procedures, quality of movement, excitability, lethargy, number of non-optimal reflexes, number of asymmetric reflexes, hypertonicity, and hypotonicity and an additional stress/abstinence scale. | 1-7 days and 4 weeks | 
| Infant development as measured by Bayley's scales for infant development 3rd edition (BSID-III-R, Bayley, 2006) | The BSID III-R is a structured observation test assessing cognition, language and motor skills. | 16 and 52 weeks of infant age | 
| Infant stress exposure and physiological stress-sensitivity as measured by hair and salivary cortisol | Saliva samples are collected before and 20 and 40 minutes after NNNS (4 weeks), still-face procedure (16 weeks) and Strange Situation Procedure (52 weeks) | 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) | CIB is a global measure that looks at parent-child and dyadic affective states and interactive styles. Independent behavioral codes are aggregated into eight higher order constructs: The three child constructs are engagement involvement, withdrawal, and compliance; and the two dyadic constructs are dyadic reciprocity and dyadic negative states. | 1-7 days, 4 and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attachment, Offspring, Risk development, Resilience