Biological and psycho-social risk and resilience factors
OtherNaturalistic study, no active intervention or exposure is administered
NCT Number: NCT02306551
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.
Looking for future studies?
Notify Me16 year and older
All sexes
Observational
Department of child and adolescent mental health Odense, Research Unit, Mental Health Services in the Region of Southern Denmark, Odense, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Naturalistic study, no active intervention or exposure is administered
Time frame: 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.
Time frame: 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.
Time frame: 16 and 52 weeks of infant age
The BSID III-R is a structured observation test assessing cognition, language and motor skills.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: at baseline before birth of the infant
ACES is a 25-item self report measure that assesses exposure to childhood emotional, physical, or sexual abuse, and household dysfunction during childhood.
Time frame: During pregnancy and at infant 16 and 52 weeks of age
Time frame: At baseline before birth of the infant
AAI 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 adult constructs are sensitivity, intrusiveness, and limit-setting.
Time frame: At baseline before birth of the infant
BSI-53 is a 53 item self-report inventory.
Time frame: At baseline before birth of the infant
SAPAS is an eight-item screening interview for personality disorder.
Time frame: At baseline before birth of the infant
RIST is a screening measure of general intelligence
Time frame: At baseline and 4, 16 and 52 weeks
SOS determines two main areas of social support, emotional support and practical support.
Time frame: At baseline and at 16 and 52 weeks
Questions evaluate experiences of life being unpredictable, uncontrollable and distressing during the previous 30 days, and whether the respondent has been feeling nervous or stressed.
Time frame: At 16 weeks
Questions assess level of stress related to the parental role
Time frame: At 16 weeks
Questions assess the parenting aspects of the marital relationship.
Time frame: 52 weeks
Ages And Stages Questionnaire Social-Emotional
Susanne Harder
Other
Well Being And Resilience: Mechanisms of Transmission of Health and Risk in Parents With Complex Mental Health Problems and Their Offspring
Acronym: WARM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00001482
Anxiety Disorder, Anxiety Disorders
Bethesda, Maryland, United States
View Trial DetailsNCT07137572
Adjustment Disorder, Adjustment Disorders
Athens, Greece
View Trial DetailsNCT07436481
Mental Disorders, Psychotic Disorder
Semarang, Central Java, Indonesia
View Trial DetailsNCT01964404
Cannabis Use Disorder, Chemically-Induced Disorders
Lebanon, New Hampshire, United States
View Trial Details