Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for British Mothers of African and Caribbean Origin

Postnatal Depression Clinical Trial

Official title:

Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for Depressed British Mothers of African and Caribbean Origin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05148260
• Other study ID #: 0000-0001-5034-0335b
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: November 2022
• Source: Nottingham Trent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

Behavioral:
• Learning Through Play plus (LTP+)
Group-1: Experimental (n=40 participants) will receive the LTP+ which consist of a total of 12-group integrated treatment sessions lasting approximately 60-90 minutes per session every fortnight with 10 mother/child pair per sub-group.
• Psychoeducation
Group-2: Controlled (n=40 participants) will receive 'psychoeducation' which consist of a total of 12-group sessions lasting approximately 60-90 minutes per session every fortnight with 10 mother-child pair per sub-group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham Trent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postnatal depression is being assessed	Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Primary	Change in postnatal anxiety is being assessed	Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Primary	Change in social support is being assessed	Primary outcome measures would be assessed using the Oslo Social Support Scale	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Primary	Change in health-related quality of life is being assessed	Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Primary	Change in service satisfaction is being assessed	Outcome measure would be assessed using the brief Verona Service Satisfaction Scale	Change is being assessed at 12 weeks end of intervention
Primary	Change in child physio-emotional development is being assessed	Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Primary	Change in parenting knowledge of child development is being assessed	Outcome measure would be assessed using Learning Through Play Knowledge, Attitude and Practices (KAP) Questionnaire	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention