Depression Clinical Trial
Official title:
Early Prevention of Social Inequality in Health - an Interdisciplinary and Cross-sectorial Intervention for Vulnerable Pregnant Women
Verified date | May 2020 |
Source | Intersectoral Research Unit for Health Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the project is to develop and evaluate an interdisciplinary and cross-sectorial
intervention targeting pregnant women with psychosocial vulnerabilities. The objective is to
1) detect depression, anxiety and personality disorders in the pregnant women, 2) to increase
knowledge sharing across the health care sectors and 3) strengthen the parents' parenting
skills and thereby support a secure attachment between parents and child and thus promoting
the child's well-being.
The overriding hypothesis is that an early multi-stringed, interdisciplinary and
cross-sectorial intervention, with a long-term perspective from the early pregnancy
throughout the child's first years of life, can effectively prevent disorders in the
parent-child relation. The approach is to detect and treat depression, anxiety and
personality disorders in the mother and strengthen the parents' parenting skills in families
with maternal psychosocial vulnerabilities. The hypothesis indicates that the over-all
intervention will result in improved interaction between child and parents which will make it
possible to detect higher maternal sensitivity and a higher level of well-being among both
children and parents in the intervention group compared to the control group.
The projects' specific hypotheses are;
- A systematic screening for anxiety, depression and personality disorders in the
midwifery consultation will imply more pregnant women with symptoms of anxiety,
depression and personality disorders being detected and offered treatment in the
intervention group compared to the control group.
- Knowledge sharing across health care sectors will improve by the implementation of a
joint consultation involving the vulnerable pregnant woman/families, the midwife and the
health visitor and by a systematic transmission of information when the woman leaves the
post-natal ward and is transferred to the health visitor.
- Parental skills in psychosocial vulnerable pregnant women and their partners can be
strengthened by a parental training program and by education and dialogue about
perceived challenges and breast-feeding. Parents in the intervention group will
therefore gain greater knowledge on what it takes to make breast-feeding work
successfully, be able to interact more appropriate with their children, and improve
their mentalization skills and experience less stress compared to parents in the control
group.
Status | Completed |
Enrollment | 78 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pregnant women with psychological/psychiatric problems (care level 3*) - Pregnant women with severe social problems, either economic or familiar (care level 3*) - Pregnant women from the municipality of Ballerup, Gentofte, Herlev and Rødovre Exclusion Criteria: - Pregnant women that exclusively has incident or chronic somatic illnesses (care level 3*) - Pregnant women with problems related to alcohol, drugs and/or medicine (care level 4*) - Pregnant women that does not speak/understand the Danish language - Pregnant women under the age of 18 - The following diagnosis: Active eating disorder, Severe depression , Psychosis, Schizophrenia, Bipolar disorder. |
Country | Name | City | State |
---|---|---|---|
Denmark | Intersectoral Research Unit for Health Services | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Intersectoral Research Unit for Health Services | University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal sensitivity | Sensitive responses, that is the ability to respond appropriately to the child's attachment needs, has consistently been found to be the most reliable predictor of attachment security. The intervention, including The Circle of Security, has the aim to promote maternal sensitivity. The measurement tool "Coding Interactive Behaviour" (CIB) will be used to code maternal sensitivity towards the child. Maternal sensitivity is observed during 5 minutes interaction (free play) between mother and infant. CIB has good psychometric properties and has been validated in multiple longitudinal studies across cultures and across age groups (from newborn to adolescent). The system has previously been used for the purpose of research of the relation between a child and a mother with mental illness(es). Moreover, it has been used to evaluate the effectiveness of interventions. |
The mother-child relation will be videotaped and assessed during a home-visit by the health visitor after the intervention is finished when the child is around 9 months old. | |
Secondary | Prenatal Parental Reflective Functioning Questionnaire | Measuring the mentalization skills or reflective functioning of the parents in relation to the unborn child. | Baseline | |
Secondary | Parental Reflective Functioning Questionnaire | Measuring the mentalization skills or reflective functioning of the parents in relation to the child, and refers to the capacity to treat the child as a psychological human. Consists of three sub scales, describing high, low or nor high neither low mentalization functioning in the parents. | Second follow-up:15 months after baseline (child 9 months old) | |
Secondary | The Parenting Stress Index | Measuring stress in relation to parents and in relation to the child and dysfunctionality in the parent-child relationship. Questions are about the child's behavior, the parents' reactions and how the family functions. | Second follow-up:15 months after baseline (child 9 months old) | |
Secondary | Edinburgh Postnatal Depression Scale | Measuring maternal depressive symptoms. The effectiveness of Edinburgh Postnatal Depression Scale (EPDS) for detection of depression at a clinical level is well-documented, and has been shown to have high sensitivity and specificity against a clinical psychiatric diagnosis of depression. | Baseline, first follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old) | |
Secondary | Maternal Antenatal Attachment Scale | Measuring maternal attachment to the unborn child, in terms of thoughts, feelings and behavior towards the unborn child. There are two dimensions: the quality of the attachment (emotional closeness/distance, positive/negative feelings, tenderness/irritation aimed at the unborn child) and intensity/time the mother is in attachment mode (how involved the woman is with the fetus) | Baseline | |
Secondary | Warwick Edinburg Mental Well-being Scale | Measuring mental well-being in a broad understanding of the condition. Includes positive emotion, psychological function and interpersonal relations. All questions are formulated in positive phrases. | Baseline, first follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old) | |
Secondary | Ages and Stages Questionnaire - Social Emotional | Measuring the infant's socio-emotional development. The mother and father should complete the questionnaire and the responses are assessed separately. Includes self-regulation, compliance, communication, adaptive functioning, autonomy, emotions and interaction with other people. | Second follow-up:15 months after baseline (child 9 months old) | |
Secondary | Experiences in Close Relationship - revised version | Measuring adults' attachment in close relationships. Measures 1) avoidant attachment style, characterized by fear of intimacy and interpersonal dependency and 2) fear of attachment, characterized by fear of being rejected and a craving for interpersonal closeness. | Baseline, first follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old) | |
Secondary | Family and Social Support Scale | Measuring parents perceived support from family, friends, society and their partner. The scale is used in many studies to measure the effect of social support on parents' health and well-being, family integrity, parents' perception of the child and the parent-child interaction. |
First follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old) | |
Secondary | Attitude towards breast-feeding | The mothers and the fathers attitude towards breast-feeding before birth - scales to be selected | Baseline | |
Secondary | Breast-feeding status | Self-reported breast-feeding status - scales to be selected | First follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old) | |
Secondary | APGAR-score | Summarizing the health of the newborn child, including skin colour, breath, muscular tension, heartbeat and reflexes. Measured 1, 5 og 10 minutes after birth. | At birth | |
Secondary | Birth weight | Measurement documented in the birth record immediately after birth. | At birth | |
Secondary | Length at birth | Measurement documented in the birth record immediately after birth. | At birth | |
Secondary | Head circumference at birth | Measurement documented in the birth record immediately after birth. | At birth | |
Secondary | Maternal sensitivity | Sensitive responses, that is the ability to respond appropriately to the child's attachment needs, has consistently been found to be the most reliable predictor of attachment security. The intervention, including The Circle of Security, has the aim to promote maternal sensitivity. The measurement tool "Coding Interactive Behaviour" (CIB) will be used to code maternal sensitivity towards the child. Maternal sensitivity is observed during 5 minutes interaction (free play) between mother and infant. CIB has good psychometric properties and has been validated in multiple longitudinal studies across cultures and across age groups (from newborn to adolescent). The system has previously been used for the purpose of research of the relation between a child and a mother with mental illness(es). Moreover, it has been used to evaluate the effectiveness of interventions. |
The mother-child relation will be videotaped and assessed during a home-visit by the health visitor when the child is around 1 month. | |
Secondary | Questions regarding the intervention | Qualitative questions on the participants' experiences of the intervention elements. | First and second follow up |
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