Clinical trial NCT05148260: Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for British Mothers of African and Caribbean Origin
Official title: Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for Depressed British Mothers of African and Caribbean Origin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postnatal Depression
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: By 2030, depression will be the leading global disease burden. Postnatal depression due to childbirth/parenting leads to long-term negative consequences for mothers, their children and their families. The British African/Caribbean communities are worse hit by the unprecedented impact of post-Covid-19-syndromes, leading to an exponential increase in postnatal depression. Yet, the uptake of mental healthcare by British mothers of African and Caribbean origin is low due to limited access to culturally appropriate care. Theories of attachment and cognitivism were innovatively integrated to examine Learning-Through-Play plus (LTP+) intervention for postnatal depression using a pilot randomised controlled trial. The proposed LTP+ is co-developed and ecologically friendly because it is manualised and can be delivered by non-mental health specialists such as trained community health workers who are more culturally knowledgeable. Findings will be disseminated through academic publications/presentations, policy briefs, original animated videos and podcast series laying the foundations for a psychosocial approach to tackling postnatal depression


Eligibility criteria: Inclusion Criteria

Only British mothers of African and Caribbean heritage:

* experiencing emotional distress due to childbirth or parenting and scored 5 or above on the patient health questionnaire (PHQ-9)
* who have children age 0-3 years
* residents of designated communities and available for follow-up
* are 18 years and above
* able to give informed consent.

Exclusion Criteria

Are mothers:

* with a medical condition that would prevent their participation such as active suicidal ideation, tuberculosis, or heart failure
* temporary residents are unlikely to be available for follow up
* who are less than 18 years
* unable to provide consent.
* with non-British African and Caribbean heritage.

Primary outcomes:
measure: Change in postnatal depression is being assessed
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
measure: Change in postnatal anxiety is being assessed
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
measure: Change in social support is being assessed
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
measure: Change in health-related quality of life is being assessed
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
measure: Change in service satisfaction is being assessed
timeFrame: Change is being assessed at 12 weeks end of intervention
measure: Change in child physio-emotional development is being assessed
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
measure: Change in parenting knowledge of child development is being assessed
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Secondary outcomes:
Other outcomes:
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