CClinicalTrials.gg
Not yet recruitingNCT05148260Updated Nov 18, 2022

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

An interventional study of Learning Through Play plus (LTP+) and Psychoeducation in Postnatal Depression, sponsored by Nottingham Trent University. Not yet recruiting. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by Nottingham Trent University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
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Study 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

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Conditions studied

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In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's planned enrollment of 80 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Nottingham Trent University is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • 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+)

  • 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

Interventions

  • BehavioralLearning 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.

  • BehavioralPsychoeducation

    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.

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What researchers measure

Primary outcomes

  1. Change in postnatal depression is being assessed

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

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

  2. Change in postnatal anxiety is being assessed

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

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

  3. Change in social support is being assessed

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

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

  4. 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)

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

  5. Change in service satisfaction is being assessed

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

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

  6. Change in child physio-emotional development is being assessed

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

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

  7. 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

    Time frame: 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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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05148260
Lead sponsor
Nottingham Trent University
Responsible party
Dr Dung Jidong, PhD (Senior Lecturer, Nottingham Trent University) — Principal investigator
First posted
Dec 8, 2021
Start date
Sep 1, 2023 (estimated)
Primary completion
Aug 30, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Nov 18, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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