Condition category
Mental and Behavioural Disorders
Date applied
24/09/2010
Date assigned
28/09/2010
Last edited
08/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Maternal postnatal depression (PND) is a major public health issue: it affects around 13% of mothers, and compared to children of non-depressed mothers, the children of mothers with PND are more likely to have learning, behavioural and attachment problems. Treating maternal depression alone does not improve child outcome. An intervention focusing on mother-child interactions is needed to promote these children's development. We aim to examine whether, in the context of PND, a treatment to enhance mother-child interactions leads to improved child outcome. Furthermore, since treatment can be targeted at critical aspects of functioning, a treatment study provides an opportunity to examine potential causal factors in determining child outcome. Thus, we will focus treatment on improving three key parenting capacities that are known to be compromised in PND, and examine whether this improves children's outcomes.

Who can participate?
Mothers of babies between 5-9 months with PND (a full diagnostic interview will be conducted) who live within a 35 mile radius of Headington, Oxford can enrol into the study.

What does the study involve?
Mothers with PND will receive home-based treatment from approximately six months postpartum. They will be randomised to one of two treatments: either a treatment using video-feedback (index) to improve mother-child interactions or relaxation training (control). Both groups will also receive cognitive behaviour therapy (CBT) for depression. In total each participant will receive eleven home-based therapy sessions lasting a few months altogether (between baby age 6-12 months), followed by two booster therapy sessions when their baby is around 16 months old. The two groups will be compared post treatment (child age one year) and at follow-up (child age two years) where there will be further assessment visits (at home, and one in our offices in Headington, Oxford).

What are the possible benefits and risks of participating?
CBT, which all participants will receive, is the treatment recommended by the NHS for people with depression. CBT can help an individual to make changes to the areas of your life that they are not happy with at the moment and may help people to feel better. Relaxation therapy has been shown to be an effective method of helping people to reduce tension, and is a skill that can be used at any time. The support for mother-baby communication using video-feedback treatment has been used in several research studies with mothers and babies, and in general they have enjoyed it and found it to be helpful. Participants need to put aside about an hour and a half for each therapy and assessment session. They may find some of the things we discuss with you upsetting.

Where is the study run from?
University of Oxford (UK).

When is the study starting and how long is it expected to run for?
The study started in September 2010. Recruitment is planned to go on until around August 2013, with therapy and follow-up continuing until August 2015. We plan to see around 150 mothers altogether over a total period of five years.

Who is funding the study?
The Wellcome Trust (UK).

Who is the main contact?
Mrs Valerie West or Professor Alan Stein
info@opt-study.org

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alan Stein

ORCID ID

Contact details

Department of Psychiatry
Oxford University
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

090139

Study information

Scientific title

A randomised controlled treatment trial for mothers with postnatal depression to improve children's cognitive, behavioural and attachment outcomes, as well as to treat the mothers' depression

Acronym

Study hypothesis

In the context of postnatal depression, compared to a control treatment (progressive muscle relaxation [PMR]) the index treatment (targeting mother-infant interaction) will lead to better cognitive development, fewer behaviour problems, and a higher rate of secure attachment in the children (where mothers in both groups receive cognitive behavioural therapy [CBT] for their depression).

Ethics approval

Berkshire Research Ethics Committee, 05/08/2010, ref: 10/H0505/55

Study design

Single-centre randomised controlled assessor-blinded interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request patient information material

Condition

Postnatal depression

Intervention

There are three therapies which constitute the study interventions:
1. The index group will receive a treatment aimed specifically to improve mother-infant interaction
2. The control treatment will receive progressive muscle relaxation (PMR)
3. All participants will also receive cognitive behaviour therapy (CBT) for their depression

All therapies will be delivered to each participant by the same therapist in the participant's home. Treatment will begin when the infant is 6 - 8 months of age. Initially there will be five weekly sessions, followed by five fortnightly sessions. There will be two booster sessions when the child is 16 and 20 months of age respectively.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

When the infant is 24 months of age:
1. Child cognitive development will be measured using the Bayley Scales of Infant Development Third Edition (BSIDIII). We will use the Mental Development Index as the principal outcome.
2. Behaviour problems will be assessed by the Child Behaviour Checklist (CBCL). The principal outcome will be the externalising scale of the CBCL (completed by the mother and another caregiver).
3. Attachment security will be measured by the Attachment QSort (AQS), comprising 90 items designed to measure the security of a child's attachment behaviour during naturalistic observations in the family home over a period of approximately 1.5 hours.

Secondary outcome measures

When the infant is 24 months of age:
1. 'Maternal depression will be measured using the Edinburgh Postnatal Depression Scale (EPDS) and Structured Interview for DSM IV Diagnosis (SCID). Depression at 24 months will be used as a secondary outcome.
2. Emotionregulation - two standardised tests of infant temperament will be used to elicit emotionregulation in the infants, taken from the LABTAB battery. The mean of the emotional regulation scores across both tasks will be used.
3. Sustained Infant Attention will be measured using both manual responses by the child and eyetracking using a version of the continuous performance test designed for use with 24 month olds.

Overall trial start date

01/12/2010

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with postnatal depression fulfilling criteria for major depressive disorder for at least 3 months duration
2. Willing and able to give informed consent for participation in the study
3. Aged 18 years or above
4. 5 - 8 months postpartum at screening
5. Infant born at 35 weeks gestation or more
6. Infant birthweight of 2000 g or more

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

144 (72 in each arm)

Participant exclusion criteria

1. Other severe psychiatric diagnosis
2. Life threatening or other serious physical illness
3. Serious illness or medical complication in the infant
4. Unable to converse in English
5. Mother not cohabiting with the infant

Recruitment start date

01/12/2010

Recruitment end date

01/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

CTRG
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 090139)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes