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

Completed

• Conditions: Psychotic Disorder; Depressive Disorder; Bipolar Disorder
• Interventions: Other: Biological and psycho-social risk and resilience factors

• Registration Number: NCT02306551
• Lead Sponsor: Susanne Harder

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-28
• Study First Posted: 2014-12-03
• Primary Completion: 2020-08
• Study Completion: 2021-09
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Depressive Disorder	Biological and psycho-social risk and resilience factors	Biological and psycho-social risk and resilience factors
Psychotic Disorder	Biological and psycho-social risk and resilience factors	Biological and psycho-social risk and resilience factors
Bipolar Disorder	Biological and psycho-social risk and resilience factors	Biological and psycho-social risk and resilience factors
Non-psychiatric Control	Biological and psycho-social risk and resilience factors	Biological and psycho-social risk and resilience factors

Primary Outcome Measures

Name	Time	Method
Infant attachment as measured by Strange Situation Procedure (Ainsworth et al. 1978)	At infant 52 weeks of age	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.

Secondary Outcome Measures

Name	Time	Method
Infant neurobehavioral outcome as measured by Neonatal Intensive Care Unit Neurobehavioral Scale, NNNS, (Lester & Tronick, 2005)	1-7 days and 4 weeks	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.
Infant social-interactive behavior as measured by Coding Interactive Behavior, CIB (Ruth Feldman, 2012)	1-7 days, 4 and 16 weeks	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.
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	The BSID III-R is a structured observation test assessing cognition, language and motor skills.
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	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)

Trial Locations

Locations (3)

Institute of Health and Well being, University of Glasgow; 🇬🇧 Glasgow, United Kingdom

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

Psychiatric Research Unit, Psychiatry, Region Sealand, Institute of Clinical Medicin, Faculty of Health Sciences, University of Copenhagen; 🇩🇰 Roskilde, Denmark