RecruitingACTRN12615000684527

An effect of antenatal and postnatal maternal support programs on attachment and resilience for mums and infants: A Randomised Controlled Trial.

An effect of antenatal and postnatal maternal support programs on mental health and mother-infant attachment in comparison to standard care in pregnant women at risk for mental illness: A Randomised Controlled Trial.


Sponsor

Professor Louise Newman

Enrollment

500 participants

Start Date

Aug 24, 2015

Study Type

Interventional

Conditions

Summary

Resilience is the capacity to rebound, and adjust from adverse experiences and maintain normal psychological and physical functioning, avoiding serious mental illness. Resilience can be built and fostered in an environment of protective factors. For infants the most important protective factor is having secure attachment relationships with their primary caregivers; generally their parents. However the parent-child attachment process is frequently disrupted when the parent/s have a mental illness as they may be less sensitive to the emotional cues of their children and less emotionally responsive. The purpose of this project is to test the effectiveness of two psychologically-based interventions which have been developed to help parents with mental illness or mental health concerns, become more responsive to their infant and foster a secure attachment relationship, thus building resilience in both parents and child.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing two psychological support programs designed to help pregnant women and new mothers who have a history of mental illness form a stronger, more secure bond with their babies. Researchers believe that improving the parent-child attachment early on can build resilience in both the mother and child. You may be eligible if: - You are female and 18 years of age or older - You are pregnant and receiving antenatal care at the Royal Women's Hospital - You are in your first or second trimester of pregnancy - You have a current or past history of any mental health condition (including anxiety or depression), OR you are experiencing significant social stressors (e.g., domestic violence, housing instability, or involvement with child protection services) - You have basic English literacy and communication skills You may NOT be eligible if: - You are currently experiencing acute psychosis - You have uncontrolled drug abuse - You have an intellectual disability that prevents meaningful participation - You have a serious medical illness that prevents participation - You have severe depression requiring hospitalisation - Your child has already been removed from your care - You are already participating in a therapeutic parenting or meditation program Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The population of interest for this study are expectant women booked to deliver at the Royal Women's Hospital who are referred to the mental health services.This will be a randomised controlled trial

The population of interest for this study are expectant women booked to deliver at the Royal Women's Hospital who are referred to the mental health services.This will be a randomised controlled trial (RCT) with four arms. Participants in three arms will receive an intervention. The fourth arm will be the control group. Progress through the different phases of the trial will be based on the Consolidated Standards of Reporting Trials (CONSORT) recommendations for RCTs. During pregnancy (antenatal period) one-half (n=250) of participants (Groups 1 and 3) will receive a mindfulness-based intervention in addition to treatment as usual (TAU) and the other half (n=250) will receive TAU only (Groups 2 and 4). Two months following birth (postnatal period), participants in Groups 1 and 2 with receive an attachment-based intervention in addition to TAU and Groups 3 and 4 will receive TAU only. The interventions are: 1. Antenatal mindfulness intervention aimed at addressing maternal anxiety, depression and stress. The intervention comprises of five weekly sessions, with each session of 2hrs and 15mins duration. The intervention will be delivered by mental health and health professionals (e.g., psychologists, midwives and maternal and child health care nurses) who have been trained and supervised by Dr Mercuri. 2. Postnatal attachment-focused intervention focused on infant-parent interactional coaching and improving parental reflective capacity. The intervention comprises of 10 weekly sessions, with each session of 1.5-2 hours duration. The first session will take place approximately 2 months post delivery. The intervention will be delivered by mental health and health professionals (e.g., psychologists, maternal and child health care nurses) who have been trained and supervised by Prof. Newman. Adherence to the interventions will be monitored via an attendance registry.


Locations(1)

The Royal Women's Hospital - Parkville

VIC, Australia

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ACTRN12615000684527


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