Postnatal depression Mental and Behavioural Disorders Postnatal depression
Conditions
Interventions
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 re
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 28/11/2017: When the infant is 24 months of age: 1. Child cognitive and language development were measured using the Bayley Scales of Infant Development-Third Edition (BSID-III). 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). 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. Previous 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 28/11/2017: 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. Emotion regulation, measured using the barrier paradigm from the LABTAB battery. 3. Sustained Infant Attention will be measured using the ECBQ (Early Childhood Behaviour Questionnaire) for child attention. 4. Children’s ability to discriminate facial expressions of emotion, measured using the emotion discrimination task. Positive (happy), negative (sad) and neutral (calm) adult faces were presented for 100 ms each on a screen linked to an eye-tracker. Previous 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. Emotion regulation - two standardised tests of infant temperament will be used to elicit emotion regulation 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. | — |
Countries
United Kingdom
Outcome results
None listed