Evaluating Interventions in RCTs During the Perinatal Period

A focus of PIRI’s research is the production of validated interventions that are brief, cost-effective and translatable into every-day practice.

PIRI has conducted numerous randomised, controlled trials to produce brief interventions for ante and postnatal depression. This includes programs targeting both the mental health of mothers and infants.

PIRI researchers published the first evidence from a RCT that treating maternal depression in pregnancy can promote better developmental outcomes in children (Milgrom et al., 2015). We subsequently published a follow-up in later childhood (Milgrom, Holt, et al., 2019) and two additional articles reporting on genome-wide methylation patterns and structural brain differences in children of treated and untreated mothers (Bleker et al., 2019a;. Bleker et al., 2019b; Milgrom, Holt, et al., 2019).

Currently we are undertaking a large, NHMRC-funded RCT, Beating the Blues before Birth, addressing this critical question (click here for more details).

The relationships between stress and brain development has been a focus of PIRI research and led to longitudinal research in high-risk preterm infants (NHMRC 2006-13).

The relationships between stress and brain development has been a focus of PIRI research and led to longitudinal research in high-risk preterm infants (NHMRC 2006-13) and in children whose mothers have been treated with cognitive behavioural therapy (CBT) for depression in pregnancy (NARSAD 2016-17)

PremieStart, developed by PIRI, is an intervention for parents trained to reduce the stress experienced by their preterm infant whilst staying in the Neonatal Intensive Care Unit (for more information on the intervention click here). Our landmark publications have demonstrated improved infant brain structure and white matter connectivity (visible on MRI scans) (Milgrom et al., 2010) as well as a positive impact on early infant development (Milgrom et al., 2013) following this stress reduction intervention.

We have recently published the primary outcomes from a large NHMRC-funded RCT of PremieStart (Milgrom, Martin, et al., 2019) and several associated publications are in preparation for peer reviewed journals. We are currently funded by Austin Medical Research Fund for a 9-year follow up academic achievement in children from this cohort.

Children whose mothers were treated with CBT for antenatal depression:

In a recent exploratory study, we examined whether CBT for maternal antenatal depression ameliorates the offspring’s brain structure. Promising results were found suggesting increased cortical thickness, increased gray matter concentration and reduced connectivity in several brain regions (Bleker, Milgrom, et al. 2019)

PIRI’s longstanding interest extends from early findings of a protective role for the mother-infant relationship with a neurophysiologic base, to more recent parent-infant interventions.

PIRI’s longstanding interest extends from early findings of a protective role for the mother-infant relationship with a neurophysiologic base, to more recent parent-infant interventions. Professor Jeannette Milgrom established the Parent-Infant Research Institute in 2001 to focus on infancy research.

At PIRI we are interested in designing interventions and completing high-quality RCTs in the perinatal period. This has included a number of programs developed to target both the mental health of new mothers and at-risk infants (e.g. stress-reduction intervention in preterm infants). PIRI researchers were amongst the first to show that even when postnatal depression (PND) is treated effectively, this does not reverse the accompanying stress that mediates many of the negative effects of PND on the mother-infant relationship and ultimately infant development. One of our significant papers elegantly relates early interaction deficits to later cognitive outcome.

Including pregnant and postpartum women, couples, fathers and in various formats (e.g. self-help, distance therapy, group, individual, Web-based).

This includes perinatal mental health programs for pregnant women, couples, fathers and delivery in different formats (e.g. self-help workbook, distance therapy, group, individual). PIRI focuses on prevention as well as treatment. And has pioneered the treatment of Antenatal Depression and Anxiety to protect later child development. PIRI’s expertise lies in RCTs and developing interventions reflect an ability to synthesize and translate knowledge about mood and behaviour in the perinatal period into effective interventions (research translated to practice).

A highlight has been the development of the MumMoodBooster intervention to its delivery-ready stage, supported by a team of international experts. Prof. Milgrom (CI), a leading expert in the identification and treatment of PND, has worked in close collaboration with Drs. Danaher and Seeley at the Oregon Research Institute (ORI) who have very considerable expertise in the innovative design and evaluation of Web-based behavioural interventions

With NIMH funding, over the course of almost three years the MumMoodBooster Web-based CBT intervention for PND was developed. The PIRI team worked together with Dr Brian Danaher and Dr John Seeley at ORI. Drawing on our Getting Ahead of Postnatal Depression program, a systematic, iterative development process followed the Science Panel on Interactive Communications and Health guidelines (Henderson et al., 1999) consistent with a staged approach for the development and testing of behavioural interventions. MumMoodBooster has been evaluated and has found to be effective in a randomised controlled trial as compared to treatment as usual. A recent trial has compared MumMoodBooster directly to face-to-face psychological therapy, with encouraging results.To add to our existing range of evidence-based mental health support programs for new and expectant parents, the team at PIRI are currently working on a world-first specialised Web-based treatment for depressed or anxious new fathers, Man vs. Mood.

Depressed new fathers rarely access traditional support services, and their symptoms go largely unacknowledged and untreated. This new program will be based upon the cognitive behavioural therapy (CBT) approach of our successful MumMoodBooster treatment program for new mums.

This book discusses evidence-based practice in screening, psychosocial assessment, and management of the mental well-being in mothers.

Identifying Perinatal Depression and Anxiety was edited by PIRI’s research directors Professor Jeannette Milgrom and Dr Alan Gemmill and includes the contributions of experts from Australia and around the world. This book discusses evidence-based practice in screening, psychosocial assessment, and management of the mental well-being in mothers.

Identifying Perinatal Depression and Anxiety brings together the very latest research and clinical practice on this topic from around the world in one valuable resource.

It examines current screening and management models, particularly those in Australia, England and Wales, Scotland, and the United States. It discusses the evidence, accuracy, and limitations of screening methods in the context of challenges, policy issues, and questions that require further research. The book also includes up to date practical guidance of how to screen, assess, diagnose and manage is provided and considers the importance of screening processes that involve infants and fathers, additional training for health professionals, pathways to care following screening, and the economics of screening. The authors offer forward-thinking synthesis and analysis of the current state of the field by leading international experts, with the goal of sketching out areas in need of future research.