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

Primary Purpose

Postnatal Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Learning Through Play plus (LTP+)
Psychoeducation
Sponsored by
Nottingham Trent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postnatal Depression

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    LTP+

    Psychoeducation

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    Change in postnatal depression is being assessed
    Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
    Change in postnatal anxiety is being assessed
    Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
    Change in social support is being assessed
    Primary outcome measures would be assessed using the Oslo Social Support Scale
    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 in service satisfaction is being assessed
    Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
    Change in child physio-emotional development is being assessed
    Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 11, 2021
    Last Updated
    November 15, 2022
    Sponsor
    Nottingham Trent University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05148260
    Brief Title
    Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for British Mothers of African and Caribbean Origin
    Official Title
    Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for Depressed British Mothers of African and Caribbean Origin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2026 (Anticipated)
    Study Completion Date
    August 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nottingham Trent University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postnatal Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LTP+
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Psychoeducation
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    Learning Through Play plus (LTP+)
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducation
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in postnatal depression is being assessed
    Description
    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
    Title
    Change in postnatal anxiety is being assessed
    Description
    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
    Title
    Change in social support is being assessed
    Description
    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
    Title
    Change in health-related quality of life is being assessed
    Description
    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
    Title
    Change in service satisfaction is being assessed
    Description
    Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
    Time Frame
    Change is being assessed at 12 weeks end of intervention
    Title
    Change in child physio-emotional development is being assessed
    Description
    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
    Title
    Change in parenting knowledge of child development is being assessed
    Description
    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

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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