Perinatal mental health Mental and Behavioural Disorders
Conditions
Interventions
This study is a multi-centre randomised controlled trial, in which members of the study team that conduct outcome assessments with participants will be blind to participant allocation and women are ra
Sponsors
Anna Freud Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women and other birthing parents who: 1. Are accessing a community perinatal mental health services (PMHS) from one of the 9 recruiting sites 2. Have a child aged 0-12 months with no severe illness or developmental disorder 3. Score 1.1 or more as their average score on the CORE-10 or 1 or more as their average score on the CORE-OM 4. Score 12 or more on the general factor of the Postnatal Bonding Questionnaire (PBQ) or 26 or more on their total PBQ score 5. Are aged at least 18 years and are willing and able to give informed consent 6. Are able to attend groups without being under the influence of substances NHS staff members who: 1. Are currently working in one of the PMHS involved in the trial
Exclusion criteria
Exclusion criteria: Women and other birthing parents who: 1. Do not meet the inclusion criteria 2. Do not have a minimum of conversational English 3. Have received COS-P previously 4. Are experiencing active psychosis NHS staff: 1. NHS staff members who do not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal mental health symptoms measured using CORE-OM at baseline, 3 months, 7 months and 12 months follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mother-infant relationship difficulties measured by the Postpartum Bonding Questionnaire (PBQ) at baseline, 3, 7, and 12 month follow up 2. Maternal emotion regulation ability measured by the DERS at baseline, 3, 7, and 12 month follow up 3. Global infant development in communication, motor and cognitive areas measured by the Ages and Stages Questionnaire-3 (ASQ-3) at baseline, 3, 7, and 12 month follow up 4. Infant development in social and emotional behaviours measured by the Socio-Emotional (ASQ-SE) at baseline, 3, 7, and 12 month follow up 5. Observed maternal sensitivity assessed by coding of video recordings of mother-child interactions in accordance to the National Institute of Child Health and Human Development (NICHD scales) at baseline, 3, 7, and 12 month follow up 6. Child attachment security assessed by coding of video recordings of the Strange Situation Procedure (SSP) at 12 months follow up 7. Mother-child co-regulation of emotion measured with heart rate monitors worn during the SSP which are used for State Space Grids coding at 12 months follow up 8. Quality of life used for economic evaluation measured by the EuroQol- 5 Dimension (EQ-5D-5L) at baseline, 3, 7, and 12 month follow up 9. Health service usage, accommodation and living situation, income, employment and benefits measured using the Client Service Receipt Inventory (CSRI) at baseline, 3, 7, and 12 month follow up 10. Maternal maltreatment history measured by Childhood Trauma Questionnaire-Short Form (CTQ-SF) at baseline 11. Adverse events and serious adverse events (e.g., eye strain from online measures, start of social care involvement for the family) reported via a short questionnaire at 3, 7 and 12 months follow up | — |
Countries
England, United Kingdom
Outcome results
None listed