Psychotic DisorderWARMNCT02306551
Well Being And Resilience: Mechanisms of Transmission of Health and Risk
An observational study of Psychotic Disorder and Bipolar Disorder, run by Susanne Harder at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Psychotic Disorder, Bipolar Disorder, Depressive Disorder
- What is being tested?
- Biological and psycho-social risk and resilience factors
- How many people
- 93 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2014to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Unable to provide informed consent to participate
- Unable to speak English or Danish because of the requirement to complete assessments,
- Miscarriage.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Denmark2 sites
Department of child and adolescent mental health Odense, Research Unit, Mental Health Services in the Region of Southern Denmark
Odense, 5000
Psychiatric Research Unit, Psychiatry, Region Sealand, Institute of Clinical Medicin, Faculty of Health Sciences, University of Copenhagen
Roskilde, 4000
United Kingdom1 site
Institute of Health and Well being, University of Glasgow
Glasgow
About this study
Official title: Well Being And Resilience: Mechanisms of Transmission of Health and Risk in Parents With Complex Mental Health Problems and Their Offspring
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.
- Conditions
- Psychotic Disorder, Bipolar Disorder, Depressive Disorder
- Being tested
- Biological and psycho-social risk and resilience factors
- Keywords
- Offspring, Attachment, Risk development, Resilience
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological and psycho-social risk and resilience factorsOther
Naturalistic study, no active intervention or exposure is administered
| Study group | Role | What they receive |
|---|---|---|
| Psychotic Disorder | Biological and psycho-social risk and resilience factors Receives: Other: Biological and psycho-social risk and resilience factors | |
| Bipolar Disorder | Biological and psycho-social risk and resilience factors Receives: Other: Biological and psycho-social risk and resilience factors | |
| Depressive Disorder | Biological and psycho-social risk and resilience factors Receives: Other: Biological and psycho-social risk and resilience factors | |
| Non-psychiatric Control | Biological and psycho-social risk and resilience factors Receives: Other: Biological and psycho-social risk and resilience factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At infant 52 weeks of age
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 1-7 days, 4 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2020
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Harder
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Psychiatric Research Unit, Region Zealand, Denmark, Region of Southern Denmark
- Responsible party
- Sponsor-investigator, Susanne Harder, University of Copenhagen
- Investigators
- Susanne Harder, PhD, Principal investigator, Department of Psychology, University of Copenhagen, DenmarkAndrew Gumley, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306551
- Sponsor's protocol ID
- DFF-1319-00103
- Acronym
- WARM
- Status last verified
- Jan 2023
- First submitted
- 12 Nov 2014
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Stender S, Davidsen KA, Lyons-Ruth K, Harder S. Disinhibited attachment behavior among infants reared at home: Relations to maternal severe mental illness and personality disorder symptoms. Personal Disord. 2024 May;15(3):207-212. doi: 10.1037/per0000653. Epub 2024 Feb 8.
PubMed 38330355Harder 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.
PubMed 26654720
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well Being And Resilience: Mechanisms of Transmission of Health and Risk in Parents With Complex Mental Health Problems and Their Offspring
- ClinicalTrials.gov ID
- NCT02306551
- Acronym / sponsor ID
- WARM / DFF-1319-00103
- Conditions
- Psychotic Disorder, Bipolar Disorder, Depressive Disorder
- Keywords
- Offspring, Attachment, Risk development, Resilience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Susanne HarderUniversity, hospital or other
- Collaborators
- University of Glasgow, Psychiatric Research Unit, Region Zealand, Denmark, Region of Southern Denmark
- Study start
- Sep 2014
- Primary completion
- Aug 2020 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Psychotic Disorder | – | Other: Biological and psycho-social risk and resilience factorsBiological and psycho-social risk and resilience factors |
| Bipolar Disorder | – | Other: Biological and psycho-social risk and resilience factorsBiological and psycho-social risk and resilience factors |
| Depressive Disorder | – | Other: Biological and psycho-social risk and resilience factorsBiological and psycho-social risk and resilience factors |
| Non-psychiatric Control | – | Other: Biological and psycho-social risk and resilience factorsBiological and psycho-social risk and resilience factors |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- Unable to provide informed consent to participate
- Unable to speak English or Danish because of the requirement to complete assessments,
- Miscarriage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological and psycho-social risk and resilience factorsNaturalistic study, no active intervention or exposure is administered | Other | Bipolar Disorder, Depressive Disorder, Non-psychiatric Control, Psychotic Disorder |
Primary outcome
Infant attachment as measured by Strange Situation Procedure (Ainsworth et al. 1978)
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.
4 secondary outcomes
Infant neurobehavioral outcome as measured by Neonatal Intensive Care Unit Neurobehavioral Scale, NNNS, (Lester & Tronick, 2005)
Time frame: 1-7 days and 4 weeks
Infant development as measured by Bayley's scales for infant development 3rd edition (BSID-III-R, Bayley, 2006)
Time frame: 16 and 52 weeks of infant age
Infant stress exposure and physiological stress-sensitivity as measured by hair and salivary cortisol
Time frame: 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)
Time frame: 1-7 days, 4 and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 38330355Stender S, Davidsen KA, Lyons-Ruth K, Harder S. Disinhibited attachment behavior among infants reared at home: Relations to maternal severe mental illness and personality disorder symptoms. Personal Disord. 2024 May;15(3):207-212. doi: 10.1037/per0000653. Epub 2024 Feb 8.
- Derived from this study: PubMed 26654720Harder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Harder, PhD principal investigator
Department of Psychology, University of Copenhagen, Denmark
Andrew Gumley, PhD principal investigator
University of Glasgow
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorder and Bipolar Disorder, run by Susanne Harder at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant attachment as measured by Strange Situation Procedure (Ainsworth et al. 1978) (time frame: At infant 52 weeks of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306551, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.