Perinatal depression Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients must satisfy all of the following to be considered for study entry: 1. Adolescents aged less than 20 years 2. Must score 12 or more on the Edinburgh Postnatal Depression Scale, a score that we have found to reliably identify persons meeting the criteria of DSM-V major depression of at least moderate intensity. 4. Fetal gestational age less than 36 weeks. 3. Provide signed informed consent (if less than 16 years of age, a parent or guardian must also provide signed consent).
Exclusion criteria
Exclusion criteria: 1. Immediate need for medical attention. 2. Actively suicidal (a structured approach for identifying risk of suicide in those enrolled in the trial and for responding appropriately to it is being implemented). 3. Unlikely to be in the neighborhood in the following 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 02/03/2020: 1. The difference in the level of depressive symptoms between the intervention and usual care groups as assessed with the Edinburgh Postnatal Depression Scale (EPDS) at 6 months postnatal 2. Level of parenting skills measured from the total and subscale scores of the Infant-Toddler version of the Home Inventory for Measurement of Home Environment (HOME-IT) at 6 months postnatal Previous primary outcome measure: 1. Difference in parenting skills at 6 months as assessed with the Infant-Toddler version of the Home Inventory for Measurement of Home Environment (HOME-IT) 2. Difference in the level of depressive symptoms as assessed with the EPDS. Assessments of participants being conducted at baseline (within 72 hours following enrolment) and at 3-, and 6-month post-natal periods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 02/03/2020: 1. Depression remission rates as assessed with the Edinburgh Postnatal Depression Scale (EPDS) conducted at 3 or 6 months postnatally with those with an EPDS score that has fallen <6 deemed as being in remission 2. Level of disability as assessed using the WHO Disability Assessment Scale conducted at 3 or 6 months postnatally 2. Maternal attitude and adjustment to pregnancy and motherhood as measured with the Maternal Adjustment and Maternal Attitude scale (MAMAS) conducted at 3 or 6 months postnatally 3. Quality of life using the short form of the WHO Quality of Life scale (WHOQoL-BREF) conducted at 3 or 6 months postnatally 4. The extent of mother-infant interactions assessed using the Postnatal Bonding Questionnaire (PBQ) conducted at 3 or 6 months postnatally 5. Contraceptive measures used (if any) after the index childbirth assessed through the family planning and new pregnancy questionnaire (designed by the investigators) conducted at 3 or 6 months postnatally 6. Availability of social support for the adolescent mothers as assessed by the Perinatal Infant Care Social Support scale (PICSS) conducted at 3 or 6 months postnatally 7. Infant health and development assessed by weight, height, and head circumference at birth, 3 and 6 months, and through nutritional history (breastfeeding), vaccinations received, and social, cognitive, and physical developmental milestones achieved, as recorded at 3 and 6 months Previous secondary outcome measures: Conducted at 3-, and 6-month postnatal periods: 1. Depression remission rates (EPDS score <6) 2. Level of disability as assessed using the WHO Disability Assessment Scale 3. Maternal attitude and adjustment to pregnancy and motherhood as measured with the Maternal Adjustment and Maternal Attitude scale (MAMAS) 4. Quality of life using the short form of the WHO Quality of Life scale, WHOQoL-Brief 5. Level of anxiety, using the Generalized Anxiety Disorder Assessment scal | — |
Countries
Nigeria