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NCT Number: NCT05148260

Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for 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

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Key information

Conditions

Postnatal Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Nottingham Trent University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2021
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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