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

Inclusion Criteria4

  • Have basic English literacy and communication skills to enable them to participate in the assessment and intervention processes;
  • Receiving antenatal care and booked to deliver at the Royal Women's Hospital
  • Up to 2nd trimester
  • Considered ‘at risk’, where 'at risk' includes women who have a current or past personal or family (first degree relatives only) history of any mental illness including symptoms of anxiety and depression, and/or have current psychosocial stressors (e.g., poor social support, unstable accommodation, intimate partner violence, contact with Department of Human Services Protective Services).

Exclusion Criteria7

  • Acute psychosis
  • Uncontrolled drug abuse
  • A level of intellectual disability which will prevent the woman from understanding and communicating sufficiently to participate in the assessment and intervention processes
  • a known serious medical illness which will preclude participation
  • major depression requiring hospitalisation or precluding them from participating
  • Child removed from parental care (mother not primary attachment figure)
  • Already engaged in a parenting or meditative program that is therapeutic in nature

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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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