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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorNottingham Trent University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: LTP+Experimental treatment 1 intervention
Group B: PsychoeducationActive comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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