Online LTP+CaCBT for Treating Depression in British Mothers of African/Caribbean Heritage

November 22, 2021 updated by: Dr Dung Jidong, PhD, Nottingham Trent University

Online Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy (LTP+CaCBT) for Treating Depression in British Mothers of African and Caribbean Heritage: A Pilot Randomised Controlled Trial

The pilot trial aims to test the feasibility, acceptability and cultural appropriateness of online LTP+CaCBT for treating postnatal depression and to improve the mental health and wellbeing of mothers and their children in the UK.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants who scored 5 or above on Patient Health Questionnaire (PHQ-9) will be would be recruited and randomly assigned into one of two groups (experimental or controlled). Experimental groups will receive the online LTP+CaCBT treatment - the intervention will consist of a total of 12 group training sessions (approx. 60 minutes each). The controlled groups will receive 'placebo effects' in the form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. Each of the two groups (both experimental and controlled) will be comprised of approximately 10 mother-child pairs per sub-group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • England
      • Nottingham, England, United Kingdom, NG1 4FQ
        • Recruiting
        • Nottingham Trent University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years and above
  • A mother with a child (0-3 years) from the African and/or Caribbean heritage
  • Able to provide full consent for their participation
  • A resident of the UK
  • Able to complete a baseline assessment
  • Score 5 or above on Patient Health Questionnaire (PHQ-9)

Exclusion Criteria:

  • Less than 18 years
  • Medical disorder that would prevent participation in a clinical trial such as Tuberculosis or heart failure
  • Temporary residents are unlikely to be available for follow up
  • Active suicidal ideation or any other severe mental disorder
  • Non-residents of the UK
  • Unable to consent
  • Patients currently undergoing severe mental health treatment
  • Unable to speak the English language fluently
  • Other significant physical or learning disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LTP+CaCBT
The LTP+CaCBT intervention will consist of 10 (mother-child pairs) participants per sub-group in online group sessions (approx. 60 minutes each) and will deliver one session every fortnight for 12 sessions.
Behavioral: LTP
LTP is a low-literacy, sustainable programme that will provide depressed mothers with valuable skills on parenting, improve mother-child relation and mental health self-care. This is a research-based activity that enhances postnatal mental health while simultaneously promoting attachment security through building parents' ability to monitor and be sensitive to their children's cues, and thereby, actively involves in their children's mental and physical development.
Other Names:
  • Learning Through Play
Behavioral: CaCBT
CaCBT adopts 'here and now' problem-solving approach, which involves collaborating with families, active listening techniques, changing negative thinking, and depressive symptoms associated with postnatal depression and other forms of parenting distress.
Other Names:
  • Cultural adapted Cognitive and Behaviour Therapy
Active Comparator: Psychoeducation
This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. The psychoeducation would last approximately 60 minutes each for 12 sessions (10 participants per sub-group). One session would be delivered every fortnight for 12 sessions.
Behavioral: Psychoeducation
This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in postnatal depression is being assessed
Time Frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale
Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Change in postnatal anxiety is being assessed
Time Frame: Change is being assessed from baseline, 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
Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Change in health is being assessed
Time Frame: Change is being assessed from baseline, 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)
Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Change in social support is being assessed
Time Frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary outcome measures would be assessed using the Oslo Social Support Scale
Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Change in health-related quality of life is being assessed
Time Frame: Change is being assessed from baseline, 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)
Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Change in service satisfaction is being assessed
Time Frame: Change is being assessed at end of intervention, at 3-months and at 6-months post-intervention
Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
Change is being assessed at end of intervention, at 3-months and at 6-months post-intervention
Change in child physio-emotional development is being assessed
Time Frame: Change is being assessed from baseline, 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
Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Change in parenting knowledge of child development is being assessed
Time Frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Outcome measure would be assessed using the Learning through Play (LTP) Knowledge, Attitude and Practices (KAP) Questionnaire
Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nottingham Trent University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sheffield Hallam University
University of Manchester
Teesside University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0000-0001-5034-0335a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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