A Good Start to Life - an Early Cross-sectorial Intervention

NCT03190707 | Completed DMC

• 1 other identifier: CSU-2017-001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Attachment Disorder; Maternal Sensitivity; Depression; Personality Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Prenatal Parental Reflective Functioning Questionnaire

  Baseline

• Parental Reflective Functioning Questionnaire

  Second follow-up:15 months after baseline (child 9 months old)

• The Parenting Stress Index

  Second follow-up:15 months after baseline (child 9 months old)

• Edinburgh Postnatal Depression Scale

  Baseline, first follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old)

• Maternal Antenatal Attachment Scale

  Baseline

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention consists of three key components aiming at promoting a better attachment between child and mother/parents and through that giving the child the best possible beginning of life. The three components aim at: 1) detecting ill-being in vulnerable pregnant woman and initiation of potential treatment, 2) strengthening knowledge sharing and organizing the course for the families across the sectors, 3) strengthening parenting skills.

Behavioral: Intervention

Control

NO INTERVENTION

The existing practice for psychosocial vulnerable pregnant women on Gentofte-Herlev Hospital, Denmark, will be offered for women allocated to the control group. The control group will be measured at the same follow-up periods as the intervention group.

Interventions

Intervention BEHAVIORAL

1. Detection of ill-being: An extended consultation with the midwife. The midwife will screen the women for symptoms of anxiety, depression and personality disorders. 2. Knowledge sharing: An additional midwife consultation accompanied by the health visitor. The aim of is sharing knowledge and transmission of information between the two sectors responsible for making a shared plan for the course of the process for the pregnant woman. 3. Strengthen parenting skills through: * Two visits by the health visitor before birth and eight after. The visits are based on the parent training program The Circle of Security, aiming at promoting a secure attachment between child and carer. * Teaching the woman/couple on the importance of breast-feeding and how to succeed.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intersectoral Research Unit for Health Services: lead
• University of Copenhagen: collaborator

Study Sites (1)

Intersectoral Research Unit for Health Services

Copenhagen, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32345375 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Personality Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Michaela ML Schiøtz

  Intersectoral Research Unit for Health Services

  STUDY DIRECTOR

• Anne Kristine AK Aarestrup

  Intersectoral Research Unit for Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 19, 2017
• Study Start: June 16, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)