Culturally Adapted CMAP Plus LTP for Refugee Mothers with History of Self-harm in Pakistan

December 5, 2024 updated by: Pakistan Institute of Living and Learning

Feasibility Study of a Culturally Adapted Manual Assisted Brief Psychological Intervention (CMAP) Plus Learning Through Play (LTP) for Refugee Mothers with History of Self-harm in Pakistan

Objectives:

  • To asses the feasibility and acceptability of a culturally adapted manual assisted brief psychological intervention (CMAP) plus Learning through Play (LTP) for refugee mothers with history of self-harm having children 0-33 months. (Integrated intervention called CMAP Plus)
  • To assess if CMAP Plus will reduce the repetition of self-harm in refugee mothers having children aged between 0-33 months.
  • To determine if the intervention improves infant development and maternal attachment.
  • To explore participants experiences with the intervention.

Study design and setting:

This will be a feasibility cluster randomized control trial (cRCT) of culturally adapted CMAP Plus LTP intervention with refugee mothers from Quetta and Peshawar, Pakistan.

Sample size:

We aim to recruit a sample of 80 refugee mothers in the study.

Study Overview

Status

Status

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

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

Mental health of refugees particularly mothers living in camps or in conflict areas is one of the most important issues needing special attention and intervention. Culturally adapted Manual Assisted brief Psychological intervention (CMAP) utilizes problem solving components within a brief intervention that can be widely utilized in clinical practice in reducing repetition of self-harm in people who had recently self-harmed. Similarly, LTP programme promotes child health by supporting attuned interaction between mother and child, increasing maternal awareness of the physical and emotional needs of young children, and encouraging nurture and attachment. The CMAP plus LTP intervention may contribute significantly to the evidence base of addressing mental health of refugee mothers. This study aims to evaluate whether CMAP Plus LTP is feasible, acceptable for this population and helpful to reduce the repetition of self-harm and improve child development among refugee mothers with a history of self-harm. Eligible consented participants will complete the baseline assessments using structured questionnaires. Unit of randomization will be the Union Council. Uniion councils have been slected by the research team through consultations with community advisory committees from both sites. Selected UCs will be randomized into two study arms: 1) C-MAP plus LTP added to treatment as usual and 2) Treatment as usual (TAU) alone. Participants in intervention arm will receive 10 individual sessions of CMAP plus LTP intervention for a period of 12 weeks. All sessions will be delivered by female therapists trained in CMAP Plus. Participants in TAU alone group will receive routine care that includes routine follow up by Community Health Workers (CHWs) in Pakistan. Assessments will be carried out at baseline, and completion of the intervention at 12th week (after intervention). All assessments will be rater-blind (done by independent RAs (female), not involved in delivering the intervention sessions). After post-assessments, a purposefully selected subset (stratified by age) of participants will be invited for qualitative interviews (n = up to 15 interviews) to explore their experiences and satisfaction with the intervention. On average, interviews will last for 60-90 minutes.

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 (Actual)

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.
80

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 Contact Backup

Study Locations

  • Pakistan
    • Balochistan
      • Quetta, Balochistan, Pakistan, 87300
        • Community settings
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Community settings

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years and above refugee mothers with children aged between 0-33 months.
  • History of self-harm.
  • Resident in the study site.
  • Capacity to provide informed consent.
  • Available for the duration of the study.

Exclusion Criteria:

  • Unable to provide consent due to severe mental or physical illness.
  • Unlikely to be available for the entire duration of the study.

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: CMAP Plus LTP added to TAU

C-MAP is a manual assisted intervention based on the principles of CBT which is focused on evaluation of the self-harm attempt, crisis skills, problem solving and basic cognitive techniques to manage emotions, negative thinking, and relapse prevention strategies. As family conflicts are a common issue with this group one session is focused on the use of culturally sensitive training in assertiveness and conflict management. The LTP is a community-based parenting intervention designed to deal with early child development. The central feature of the LTP intervention is a pictorial calendar devised for parents which depicts eight successive stages of child development from birth to 3 years along with illustrations of parent-child play and other activities that promote parental involvement, learning, and attachment.

This will be added to Treatment as Usual
Behavioral: CMAP Plus LTP
The LTP Plus CMAP intervention will be delivered for a period of 12 weeks, including 8 weekly sessions and 2 sessions fortnightly. First 6 sessions will be for a duration of 60-90 minutes and remaining 4 sessions will take approximately 50-60 minutes. All sessions will be delivered by female therapists trained in CMAP and LTP intervention.
No Intervention: TAU alone
TAU alone will include routine follow up by Community Health Workers (CHWs) in Pakistan. Their work includes assisting with all aspects of maternal, new-born and childcare. Participants in treatment as usual arm will receive routine care.

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
Feasibility measure
Time Frame: From baseline to 12th week (at the end of intervention)
The feasibility will be determined by collating data on recruitment and retention rates. The success criterion of feasibility will be to recruit > 50% of eligible participants.
From baseline to 12th week (at the end of intervention)
Acceptability measure
Time Frame: From baseline to 12th week (at the end of intervention)
The intervention acceptability will be assessed using data on attendance. Criterion for acceptability is a mean attendance rate of >70% of at least 7 sessions.
From baseline to 12th week (at the end of intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Suicide Attempt Self-Injury Interview
Time Frame: From baseline to 12th week
Repetition rate of self-harm at 3 months after randomisation as measured by adapted Suicide Attempt Self-Injury Interview. The questionnaire records self-harm events by severity and chronological order.
From baseline to 12th week
Beck Scale for Suicide Ideation
Time Frame: Change in problem scores from baseline to 12th week
This is a 19-item instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviours, and specificity of a patient's thoughts to kill him/herself during the past week.
Change in problem scores from baseline to 12th week
Beck Depression Inventory
Time Frame: Change in problem scores from baseline to 12th week
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
Change in problem scores from baseline to 12th week
Beck Hopelessness Scale
Time Frame: Change in problem scores from baseline to 12th week
This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.
Change in problem scores from baseline to 12th week
Generalized Anxiety Disorder
Time Frame: Change in problem scores from baseline to 12th week
This is a 7-item scale used to screen for and measure severity of Generalized Anxiety Disorder.
Change in problem scores from baseline to 12th week
Assessment of the growth and development of children
Time Frame: Change from baseline to 12th week
Anthropometric measures of child growth will be collected through measuring children's height, weight and head circumference
Change from baseline to 12th week
Ages and Stages Questionnaire and ASQ Socio-emotional Scales
Time Frame: Change from baseline to 12th week
Ages and Stages Questionnaire and ASQ Socio-emotional scales will be used to measure child development. Parents will report on their child's communication, gross motor, fine motor, problem solving and personal-social development at different time points.
Change from baseline to 12th week
Coping resource inventory
Time Frame: Change from baseline to 12th week
Coping resource inventory will assess the coping resources to manage stress available to an individual.
Change from baseline to 12th week
Problem Solving Inventory
Time Frame: Change in problem scores from baseline to 12th week
The Problem-Solving Inventory assesses an individual's awareness and evaluation of his or her problem-solving abilities or styles. The problem-solving Inventory is a self-report measure, and thus assesses perceptions of problem solving as opposed to actual problem-solving skills.
Change in problem scores from baseline to 12th week
Infant Development Questionnaire
Time Frame: Change from baseline to 12th week
Infant Development Questionnaire is a 20-item questionnaire of paternal knowledge and expectations for child development in the first three years.
Change from baseline to 12th week
Parenting Stress Index - Short Form
Time Frame: Change from baseline to 12th week
Parents rated 36 item scale on five-point scale (1-5). The scale consists of three subscales: (1) Parenting Distress, (2) Difficult Child Characteristics, and (3) Dysfunctional Parent-Child Interaction.
Change from baseline to 12th week
Multidimensional Scale of Perceived Social Support
Time Frame: Change from baseline to 12th week
This brief scale will assess perceived social support.
Change from baseline to 12th week
Euro-Qol-5 Dimensions scale
Time Frame: Change in problem scores from baseline to 12th week
Health-related quality of life will be measured using the Euro-Qol-5 Dimensions scale. This is a standardized instrument that measures five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored from 1 to 3 indicating "no problem" to "severe problems".
Change in problem scores from baseline to 12th week
Client Service Receipt Inventory
Time Frame: Change from baseline to 12th week
This inventory will collect information about the use of other health services (including the informal sector faith healers/Imams) using CSRI based on our previous work in Pakistan
Change from baseline to 12th week
Client Satisfaction Questionnaire
Time Frame: Change from baseline to 12th week
The participants will rate their satisfaction with treatment using the Client Satisfaction Questionnaire.
Change from baseline to 12th week

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.
Pakistan Institute of Living and Learning

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.
University of Manchester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nasim Chahudhry, Pakistan Institute of Living and Learning
  • Principal Investigator: Nusrat Husain, University of Manchester

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.
April 1, 2022

Primary Completion (Actual)

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.
December 15, 2023

Study Completion (Actual)

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.
December 1, 2024

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).
December 11, 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.
December 11, 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.
December 28, 2021

Study Record Updates

Last Update Posted (Estimated)

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.
December 10, 2024

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.
December 5, 2024

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.
December 1, 2024

More Information

Terms related to this study

Keywords

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.
  • SAHAR M-CMAP Plus LTP-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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