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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postnatal Depression
• Intervention / Treatment: Behavioral: Learning Through Play plus (LTP+); Behavioral: Psychoeducation

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
Active Comparator: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Nottingham Trent University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): August 30, 2026
• Study Completion (Anticipated): August 30, 2026

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 0000-0001-5034-0335b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No