LTP+CaCBT for Treating Postnatal Depression in British Mothers of African and Caribbean Origin

Sponsor
Nottingham Trent University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05148260
Collaborator
(none)
80
2
35.9

Study Details

Study Description

Brief Summary

By 2030, depression will be the worldwide leading disease burden with women more predisposed to postnatal depression due to childbirth and parenting, which can lead to long-term consequences for the child. The uptake of mental health services by British mothers of African/Caribbean origin is low due to a lack of access to culturally appropriate care. The ongoing impact of the Covid-19 pandemic has exponentially increased postnatal depression. However, this project aims to test the acceptability and cultural appropriateness of the proposed intervention using pilot trials to treat postnatal depression and improve child wellbeing in British African/Caribbean mothers and children. It is anticipated that findings will facilitate scale-up as the intervention is evidence-based, ecologically friendly, manualised and can be delivered by non-mental health specialists such as trained community-health-workers, and thus, helps to address the workforce shortage.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT)
  • Behavioral: Psychoeducation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Treating Postnatal Depression in British Mothers of African and Caribbean Origin: A Pilot Randomised Controlled Trial
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Aug 30, 2025
Anticipated Study Completion Date :
Aug 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: LTP+CaCBT

Learning Through Play (LTP): Underpinned by Piaget's theory of cognitive development (Piaget, 1952) and Bowlby's theory of attachment (Bowlby, 1980), the central feature of the LTP component of the intervention 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 mother-child attachment. Culturally adapted Cognitive Behaviour Therapy (CaCBT): CaCBT is 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.

Behavioral: Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT)
Group-1: Experimental (n=40 participants) will receive the LTP+CaCBT 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.

Active Comparator: Psychoeducation

Involve supportive and educational components grounded on the theory and philosophy of group psychotherapy (with relevant topics on maternal mental healthcare advice and discussions), problem-solving techniques that are relevant to addressing maternal depression/anxiety and child-related difficulties, and general parenting discussions that aim at improving child's psychosocial development through mother-child attachment to promote early childhood development.

Behavioral: Psychoeducation
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.

Outcome Measures

Primary Outcome Measures

  1. Change in postnatal depression is being assessed [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Nottingham Trent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Dung Jidong, PhD, Senior Lecturer, Nottingham Trent University
ClinicalTrials.gov Identifier:
NCT05148260
Other Study ID Numbers:
  • 0000-0001-5034-0335b
First Posted:
Dec 8, 2021
Last Update Posted:
Dec 8, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2021