Clinical trial NCT03190707: A Good Start to Life - an Early Cross-sectorial Intervention
Official title: Early Prevention of Social Inequality in Health - an Interdisciplinary and Cross-sectorial Intervention for Vulnerable Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Attachment Disorder
Maternal Sensitivity
Depression
Personality Disorders
Lead sponsor: Intersectoral Research Unit for Health Services
Sponsor class: OTHER_GOV
Collaborators: name: University of Copenhagen
First posted: 2017-06-19
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study population will be stratified randomized on an individual level, thus half of the women, who agree to participate, is being randomized to the intervention group and the other half is being randomized to the control group. The trial participants will be allocated within each municipality to either control- or intervention group. The project personnel visiting the families to collect baseline data carry out the randomization. The project personnel bring a sealed envelope when visiting the families. In the envelope, the randomization group is stated together with a randomization number. The envelope is packed by a third party individual who receives a computer generated allocation list from another researcher. The envelopes get the numbers from this random sequence. The researcher generates the allocation list by block randomization with random block sizes of 2. The random allocation list is generated once and will be destroyed after the sealed envelopes are packed.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Design, material and method:

The project will be conducted as a randomized controlled trial. The intervention group will receive a specific intervention and the control group will receive care as usual, in this context the standard treatment in antenatal care for vulnerable pregnant women and by the health visitor.

Study setting:

The intervention will be executed on Herlev-Gentofte Hospital in Denmark and in four of the affiliated municipalities: Ballerup, Gentofte, Herlev and Rødovre.

Target group:

The intervention is targeted vulnerable pregnant women who do not have psychiatric diagnosis or problems related to drug abuse, are not treated at family outpatient clinic or comprehensive municipal precautionary interventions (care level 4\*), but who has the need for more than the standard treatment due to psychological and/or social challenges (e.g. previous traumas, problematic family relations or acute life crisis). Hence, the target group of the study is women with psychological or social vulnerabilities and classified as care level 3 by the hospital.

It is estimated that the project can identify 100 pregnant women from the target group from the four municipalities during the inclusion period of 10 months. An expected drop-out on 20 % will result in an expected amount of 80 pregnant women who can complete the project.

Recruitment:

Participants are recruited among pregnant women who are referred to give birth at Herlev-Gentofte Hospital. On the basis of information from the general practitioner, the referring midwife refers the pregnant women to one out of four care levels. From the above mentioned inclusion and exclusion criteria the pregnant women from care level 3\* is identified as being in the target group by the referring midwife. Afterwards, the women are recruited to the project through an enclosed invitation and information leaflet, send from the hospital together with a notice for the first midwife consultation. Next, project personnel contact the pregnant women to consult whether they are interested to participate in the research project. Then, the project personnel visit the potential participants in their homes to give further information on the project and include the interested women and their families in the project.

Selection of intervention hospitals and municipalities:

An examination of existing or previously interventions targeting vulnerable pregnant women in the Capital Region of Denmark was utilized in the process of selecting hospitals and municipalities in the intervention and control group. Herlev-Gentofte Hospital was invited to participate in the project as these hospitals were suitable with regard to the projects key intervention components and already existing interventions on the hospitals and affiliated municipalities. The included municipalities confirmed that they are not participating in other research project in the field of early prevention of social inequality in health among vulnerable pregnant women as long as this project last. The municipalities are: Herlev, Ballerup, Rødovre and Gentofte.

Data collection:

Data for evaluating the efficiency of the intervention are collected on three points of time; at baseline, after birth, when the child is aged eight weeks, and at follow-up after the intervention has finished, when the child is around nine months. All data are collected in the homes of the families. To make an extra incentive to complete the questionnaires the participants receive a gift to the value of approx. 300 dk. kr. (approx. 45 USD) when completion of the follow-up questionnaire. Baseline data is collected for both control and intervention group before participants are familiar with the allocation of the randomization. The following paragraphs will describe the type of data that will be collected. Two different questionnaires will be developed specifically for the mother and for the father. The questionnaires look alike except that the mother's questionnaire contains questions on her attachment to the child in the belly and on her attitude and perception of breast feeding.

The questionnaires will be pilot tested by individuals from the target group to ensure that the questionnaires have a manageable size for participants and that questions are relevant. Afterwards the questionnaire will be revised accordingly.

Planned statistical methods:

The analyses will be performed using the statistical software Statistical Analysis System (SAS) 9.4. Analysis and presentation of data will be in accordance with the CONSORT guidelines (reference). Standard descriptive statistics (means, medians, ranges, standard deviations, frequencies and percentages) will be used to report demographics, baseline and outcome scores. Data will be examined for missing data and multiple imputation strategies will be used if necessary. It is expected that the frequency of missing data will be low as data are collected through home interviews.

The analysis of both primary and secondary endpoints will follow the intention-to-treat principles. However, analyses taking the actual treatment participation into account will also be conducted. To examine how non-compliance affects the results different levels of participation will be investigated.

Primary and secondary outcomes will be analyzed using multiple regression for continuous outcomes, and logistics regression for binary outcomes controlling for baseline scores when possible.

\* \* The Danish Health Authority's recommendations for antenatal care prescribe the general practice to classify all pregnant women in care level 1-4 based on a psychosocial anamnesis. Pregnant classified in care level 1 receives the standard intervention; pregnant in level 2 receives an extended intervention in the context on antenatal care based on e.g. previously birth complications or disease; pregnant in level 3 receives an extended intervention including involvement of other professional groups in the health care sector or municipality based on complex social, medical or psychological problems; and pregnant in level 4 receives an extensive interdisciplinary and intersectorial intervention, including collaboration with specialized institutions based on highly complex problems e.g. alcohol or drug abuse, severe mental/psychiatric diseases and/or severe social load

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal sensitivity
timeFrame: 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 outcomes:
measure: Prenatal Parental Reflective Functioning Questionnaire
timeFrame: Baseline
measure: Parental Reflective Functioning Questionnaire
timeFrame: Second follow-up:15 months after baseline (child 9 months old)
measure: The Parenting Stress Index
timeFrame: Second follow-up:15 months after baseline (child 9 months old)
measure: Edinburgh Postnatal Depression Scale
timeFrame: Baseline, first follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old)
measure: Maternal Antenatal Attachment Scale
timeFrame: Baseline
measure: Warwick Edinburg Mental Well-being Scale
timeFrame: Baseline, first follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old)
measure: Ages and Stages Questionnaire - Social Emotional
timeFrame: Second follow-up:15 months after baseline (child 9 months old)
measure: Experiences in Close Relationship - revised version
timeFrame: Baseline, first follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old)
measure: Family and Social Support Scale
timeFrame: First follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old)
measure: Attitude towards breast-feeding
timeFrame: Baseline
measure: Breast-feeding status
timeFrame: First follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old)
measure: APGAR-score
timeFrame: At birth
measure: Birth weight
timeFrame: At birth
measure: Length at birth
timeFrame: At birth
measure: Head circumference at birth
timeFrame: At birth
measure: Maternal sensitivity
timeFrame: The mother-child relation will be videotaped and assessed during a home-visit by the health visitor when the child is around 1 month.
measure: Questions regarding the intervention
timeFrame: First and second follow up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Intersectoral Research Unit for Health Services
Study officials:
affiliation: Intersectoral Research Unit for Health Services
name: Michaela ML Schiøtz
role: STUDY_DIRECTOR
affiliation: Intersectoral Research Unit for Health Services
name: Anne Kristine AK Aarestrup
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aarestrup AK, Skovgaard Vaever M, Petersen J, Rohder K, Schiotz M. An early intervention to promote maternal sensitivity in the perinatal period for women with psychosocial vulnerabilities: study protocol of a randomized controlled trial. BMC Psychol. 2020 Apr 28;8(1):41. doi: 10.1186/s40359-020-00407-3.