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Clinical Trials/NCT05148260
NCT05148260Not yet recruitingNot Applicable

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

Nottingham Trent University0 sites80 target enrollmentStarted: September 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
80
Primary Endpoint
Change in postnatal depression is being assessed

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

LTP+

Experimental

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).

Intervention: Learning Through Play plus (LTP+) (Behavioral)

Psychoeducation

Active Comparator

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).

Intervention: Psychoeducation (Behavioral)

Outcomes

Primary Outcomes

Change in postnatal depression is being assessed

Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)

Change in postnatal anxiety is being assessed

Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale

Change in social support is being assessed

Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Primary outcome measures would be assessed using the Oslo Social Support Scale

Change in health-related quality of life is being assessed

Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)

Change in service satisfaction is being assessed

Time Frame: Change is being assessed at 12 weeks end of intervention

Outcome measure would be assessed using the brief Verona Service Satisfaction Scale

Change in child physio-emotional development is being assessed

Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire

Change in parenting knowledge of child development is being assessed

Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Outcome measure would be assessed using Learning Through Play Knowledge, Attitude and Practices (KAP) Questionnaire

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Dung Jidong, PhD

Senior Lecturer

Nottingham Trent University

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