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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05148260
Other study ID # 0000-0001-5034-0335b
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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