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

NCT ID: NCT05148260

Last Updated: 2022-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-08-30

Brief Summary

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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

Detailed Description

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Conditions

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Postnatal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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LTP+

The LTP+ is divided into two components:

First, underpinned by Piaget's theory of cognitive development (Piaget, 1952; Sidik, 2020) and Bowlby's theory of attachment (Bowlby, 1980; Granqvist \& Duschinsky, 2021), the central focus here is a pictorial calendar devised for parents, depicting eight successive stages of child development from birth to 3 years, with illustrations of parent-child play and other activities that promote parental involvement, learning, and mum-baby attachment.

Second, well-grounded in the standard framework of cognitive-behavioural theory (Bernal et al., 2009) and uses techniques of active listening, changing negative thinking, guided discovery, behavioural tasks, and homework (i.e. trying things out between sessions, putting what has been learnt into practice), while educating participating mums about depression/anxiety, correlates and management, social support, and practical advice on using appropriate healthcare (Bernal et al., 2009).

Group Type EXPERIMENTAL

Learning Through Play plus (LTP+)

Intervention Type BEHAVIORAL

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

This is the comparative group with a primary aim of monitoring participating mums to ensure their postnatal depression does not degenerate. However, supportive, and postnatal educational components are provided. These psychoeducation sessions are grounded on the theory and philosophy of group psychosocial support (with basic but relevant topics on postnatal mental healthcare advice and discussions).

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nottingham Trent University

OTHER

Sponsor Role lead

Responsible Party

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Dr Dung Jidong, PhD

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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0000-0001-5034-0335b

Identifier Type: -

Identifier Source: org_study_id

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