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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02306551
Acronym
WARM
Enrollment
93
Registered
2014-12-03
Start date
2014-09-30
Completion date
2021-09-30
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Depressive Disorder, Psychotic Disorder

Keywords

Offspring, Attachment, Risk development, Resilience

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.

Interventions

OTHERBiological and psycho-social risk and resilience factors

Naturalistic study, no active intervention or exposure is administered

Sponsors

University of Glasgow
CollaboratorOTHER
Psychiatric Research Unit, Psychiatry, Region Zealand, Denmark
CollaboratorUNKNOWN
Region of Southern Denmark
CollaboratorOTHER
Susanne Harder
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Infant attachment as measured by Strange Situation Procedure (Ainsworth et al. 1978)At infant 52 weeks of ageStrange 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

MeasureTime frameDescription
Infant neurobehavioral outcome as measured by Neonatal Intensive Care Unit Neurobehavioral Scale, NNNS, (Lester & Tronick, 2005)1-7 days and 4 weeksNNNS 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 development as measured by Bayley's scales for infant development 3rd edition (BSID-III-R, Bayley, 2006)16 and 52 weeks of infant ageThe 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 cortisol1-7 days (hair only) 4 (Saliva only), 16 and 52 weeks of infant ageSaliva samples are collected before and 20 and 40 minutes after NNNS (4 weeks), still-face procedure (16 weeks) and Strange Situation Procedure (52 weeks)
Infant social-interactive behavior as measured by Coding Interactive Behavior, CIB (Ruth Feldman, 2012)1-7 days, 4 and 16 weeksCIB 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.

Other

MeasureTime frameDescription
Maternal caregiving behavior as assessed by AMBIANCE (Lyons-Ruth, Bronfmann, & Parson, (1999). Coding Interactive Behavior, CIB (Ruth Feldman, 2012)1-7 days, 4 weeks (CIB), 16 and 52 weeks (AMBIANCE)The AMBIANCE measure is used to code disrupted caregiver behaviour during videotaped caregiver-infant interactions. The five dimensions of the AMBIANCE coding are: affective communication errors, role/boundary confusion, fearful/disorientation, intrusive/negative, and withdrawing behaviour. 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 adult constructs are sensitivity, intrusiveness, and limit-setting.
Paternal caregiving behavior as assessed by CIB16 weeksCIB 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 adult constructs are sensitivity, intrusiveness, and limit-setting.
Paternal symptom severity as assessed by Brief Symptom Severity (BSI-53,Derogatis & Melisaratos, 1983)At baseline before birth of the infantBSI-53 is a 53 item self-report inventory.
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)At baseline before birth of the infantSAPAS is an eight-item screening interview for personality disorder.
Cognitive functioning as assessed by Reynolds Intellectual Screening Test (RIST, Reynolds, Kamphaus and Raines, 2012)At baseline before birth of the infantRIST is a screening measure of general intelligence
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.PANSS, MADRS and BRMRS are rating scales based on a semistructured interview. PANSS 5-factor model assesses the presence or absence of positive, negative, disorganisation, excitement and emotional distress symptoms (van der Gaag et al., 2006). MADRS assesses the presence and severity of 10 core symptoms of depression. BRMRS assesses the presence and severity of 11 core symptoms of hypomania/mania
Perceived stress as assessed by The Perceived Stress Scale (PSS)At baseline and at 16 and 52 weeksQuestions evaluate experiences of life being unpredictable, uncontrollable and distressing during the previous 30 days, and whether the respondent has been feeling nervous or stressed.
Parenting Stress Index, 3rd Edition Short Form (PSI/SF)At 16 weeksQuestions assess level of stress related to the parental role
Parental Alliance MeasureAt 16 weeksQuestions assess the parenting aspects of the marital relationship.
ASQ-SE52 weeksAges And Stages Questionnaire Social-Emotional
Social functioning and support as assessed by Global Assessment of Functioning, GAF(DSM-IV). Significant Other Scale (SOS, Power, Chanpion & Aris)At baseline and 4, 16 and 52 weeksSOS determines two main areas of social support, emotional support and practical support.
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 educationat baseline before birth of the infantACES is a 25-item self report measure that assesses exposure to childhood emotional, physical, or sexual abuse, and household dysfunction during childhood.
Maternal stress-exposure and stress-sensitivity measured by hair and saliva cortisolDuring pregnancy and at infant 16 and 52 weeks of age
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)At baseline before birth of the infantAAI is a semi-structured interview, consisting of 20 questions and probes, allowing categorisation of an adult individual's state of mind with regard to attachment. (i.e. Secure, Dismissing and Preoccupied, Unresolved and Cannot Classify) The Adult Attachment Projective (AAP, George & West, 2012) consists of eight drawings of attachment situations dealing with illness, solitude, separation, loss, and abuse, along with one neutral scene, A narrative depiction of these drawings is transcribed and coded for attachment representation i.e.. secure, dismissing, preoccupied, or unresolved. PAM, is a self- report questionnaire assessing two dimensions of attachment, anxious and avoidant.
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)at baseline (PCEQ), 1-7 days, 4,16 and 52 weeks (CEQ)PCEQ, and CEQ assesses defensive processing associated with patterns of care-giving representation (George & Solomon, 2008). i.e. flexible integration, deactivation, cognitive disconnection and dimension of care-giving dysregulation as related to infant's secure, avoidant, ambivalent-resistant/dependent and disorganised attachment respectively.

Countries

Denmark, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026