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

NCT05148260 | Not Yet Recruiting

• 1 other identifier: 0000-0001-5034-0335b
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Postnatal Depression

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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).

Behavioral: Learning Through Play plus (LTP+)

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).

Behavioral: Psychoeducation

Interventions

Learning Through Play plus (LTP+) 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.

LTP+

Psychoeducation 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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottingham Trent University: lead

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Long-Term Potentiation

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 8, 2021
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL