Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study
Study Details
Study Description
Brief Summary
The goal of this observational study is to compare the paternal hair cortisol as a marker for chronic stress in prematurely born children to maturely born children.
The main questions it aims to answer are:
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How differ the cortisol level between groups?
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How change the cortisol level over time?
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Are there secondary outcomes associated to the cortisol level of fathers? Participants will give a hair sample to analyse the cortisol level and fill out questionnaires at three time points. At six months of the infant's age, the investigators will also measure the paternal sensitivity.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
For expectant parents, the birth of a child is often a stressful situation. In the case of a premature birth, the psychological stress is usually increased because the parents frequently could not prepare for the birth. Therefore, the researcher would like to investigate this stress of fathers of newborn children.
For this purpose, the stress hormone cortisol in the fathers' hair will be analysed and questionnaires on the fathers' mental health will be collected. Subsequently, the differences between fathers of prematurely born and of maturely born children will be compared.
The investigators will do the analyses at three time points: the first time point will be at the first week after birth, the second three months and the third six months after birth. At six months of the infant's age, additionally the paternal sensitivity will be measured.
The compared groups will differ with respect to gestational age: Group 1 includes preterm infants with a gestational age below 32 weeks and a birth weight <1500 grams (very low birthweight infants), group 2 preterm infants with a gestational age between 32 0/7 to 36 6/7 (moderate and late preterm infants) and group 3 consists of mature infants (over 37 weeks gestational age).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| fathers of mature infants Fathers of newborns' above 37 weeks of gestation |
Diagnostic Test: measurement of cortisol level
We will measure the cortisol level from the hair sample of the father at three time points. Furthermore the father will answer questionnaires at three time points and the paternal sensitivity is measured once.
Other Names:
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| fathers of moderate and late preterm infants Fathers of moderate and late preterm infants, i.e. gestational age from 32 0/7 to 36 6/7 weeks of gestation. |
Diagnostic Test: measurement of cortisol level
We will measure the cortisol level from the hair sample of the father at three time points. Furthermore the father will answer questionnaires at three time points and the paternal sensitivity is measured once.
Other Names:
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| fathers of very low birth weight preterm infants Fathers of very low birth weight preterm infants, i.e. gestational age from 22 0/7 to 31 6/7 weeks of gestation and with a birth weight below 1500 g. |
Diagnostic Test: measurement of cortisol level
We will measure the cortisol level from the hair sample of the father at three time points. Furthermore the father will answer questionnaires at three time points and the paternal sensitivity is measured once.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- hair cortisol level [first week after birth, 3 and 6 months after birth]
The level of cortisol will be measured in the hair of the fathers by liquid chromatography with tandem mass spectrometry. This test is validated in human hair and the current gold standard method in hair steroid analysis. The analytic procedure follows a published laboratory protocol that has excellent sensitivity, specificity and reliability.
Secondary Outcome Measures
- paternal sensitivity [6 months after birth]
The paternal sensitivity will be measured during a five-minute-videotape of the father changing the infants' diapers and playing with the infant. It will be measured by a 9-point scale. The score can range from 1 to 9, where 1 means lack of sensitivity and 9 means very sensitive. The classification is a validated tool and is done by two trained and reliable evaluators from the Department of Developmental Science and Special Education. The evaluators are blinded.
- paternal depression [first week, 3 and 6 months after birth]
Paternal depression is assessed with the German long form of the Center for Epidemiological Studies Depression Scale (CES-D). It is a self-report questionnaire to measure depressive symptoms and it consists of 20 questions. For each question the response choice are assigned point values (how often a symptom occurred during the last week). The point values are summed to a total measure score. The score ranges from 0 to 60. Zero points represents no symptoms of depression, a score of 15 or higher is interpreted to indicate a risk of depression.
- socioeconomic status [first week after birth]
There will be questions to the household income per month, the parents' highest school-leaving certificate and the housing situation
- social support [three months after birth]
Social support is assessed with the short German version of the questionnaire on social support (F-SozU K-22). The questionnaire records the subjectively perceived or anticipated support from the social environment. There are 22 items and the test person can indicate the degree of agreement on a five-level Likert scale (from 1 = does not apply to 5 = applies completely). The scale ranges from a minimum of 22 points to a maximum of 110 points. The higher the score, the better the subjectively perceived or anticipated support.
- impact of event scale [six months after birth]
Symptoms for post-traumatic stress is assessed with the impact of event scale - revised (IES-R). It is a self-report questionnaire and consists of 22 questions. For each question the response choice are assigned point values (how often a symptom occurred during the last week). The sub-scale values are summed by the corresponding sub-scale items. The three sub-scales are: intrusion, avoidance and hyperarousal. The overall result is calculated by a formula. The score ranges from -4,36 to 2,99. A result above 0 is interpreted to indicate a risk for post-traumatic stress disorder.
- Parental Bonding [six months after birth]
Parental Bonding is assessed with the parental bonding questionnaire (PBQ). It consists of 25 items and each item is rated on a scale from 0 to 3 points (response range from "very like" to "very unlike"). There are four sub-scales and the point values of each sub-scale are summed to a total measure score. The four sub-scales are: impaired bonding, rejection and anger, anxiety about care, risk of abuse. The higher the score, the higher the risk of a disorder in each area of the sub-scale.
- Parental Stress [six months after birth]
Parental stress is assessed with the German form of the parenting stress index (PSI). It consists of 48 items. The test person can indicate the degree of agreement on a five-level Likert scale (from 1 = does not apply to 5 = applies completely). There are 12 subscales, each consisting of 4 items and the points on the Likert scale are added. In each subscale there can be a minimum of 4 and a maximum of 20 points. The higher the score, the higher the parental stress.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Premature or mature infant (22 0/7 to 42 0/7 weeks of gestation)
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For mature infants (37 0/7 to 42 0/7 weeks of gestation) undisturbed neonatal period
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No severe malformations or genetic diseases of the newborn child
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Sufficient knowledge of German of the father
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written consent of the custodial parents
Exclusion Criteria:
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adoptive or foster paternity
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hair length below 3 cm at the posterior vertex region of the back of the father's head
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endocrine disorders, especially of the adrenocortical system (e.g. Cushing syndrome, adrenal insufficiency)
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taking steroidal medications or other drugs that affect the activity of the hypothalamic-pituitary-adrenocortical system
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paternal psychological or severe physical illness
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Cologne
- University of Siegen
Investigators
- Principal Investigator: Katrin Mehler, PD Dr., University of Cologne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-114058