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

Primary Purpose

Self-harm, Child Development

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
CMAP Plus LTP
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-harm focused on measuring Self-harm, Child development, Refugee mothers, CMAP, Learning through Play, LTP, Pakistan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Community SettingsRecruiting
  • Community settingsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CMAP Plus LTP added to TAU

TAU alone

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Feasibility measure
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.
Acceptability measure
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.

Secondary Outcome Measures

Suicide Attempt Self-Injury Interview
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.
Beck Scale for Suicide Ideation
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.
Beck Depression Inventory
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
Beck Hopelessness Scale
This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.
Generalized Anxiety Disorder
This is a 7-item scale used to screen for and measure severity of Generalized Anxiety Disorder.
Assessment of the growth and development of children
Anthropometric measures of child growth will be collected through measuring children's height, weight and head circumference
Ages and Stages Questionnaire and ASQ Socio-emotional Scales
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.
Coping resource inventory
Coping resource inventory will assess the coping resources to manage stress available to an individual.
Problem Solving Inventory
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.
Infant Development Questionnaire
Infant Development Questionnaire is a 20-item questionnaire of paternal knowledge and expectations for child development in the first three years.
Parenting Stress Index - Short Form
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.
Multidimensional Scale of Perceived Social Support
This brief scale will assess perceived social support.
Euro-Qol-5 Dimensions scale
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".
Client Service Receipt Inventory
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
Client Satisfaction Questionnaire
The participants will rate their satisfaction with treatment using the Client Satisfaction Questionnaire.

Full Information

First Posted
December 11, 2021
Last Updated
March 15, 2023
Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT05171192
Brief Title
Culturally Adapted CMAP Plus LTP for Refugee Mothers With History of Self-harm in Pakistan
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-harm, Child Development
Keywords
Self-harm, Child development, Refugee mothers, CMAP, Learning through Play, LTP, Pakistan

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CMAP Plus LTP added to TAU
Arm Type
Experimental
Arm Description
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
Arm Title
TAU alone
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CMAP Plus LTP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility measure
Description
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.
Time Frame
From baseline to 12th week (at the end of intervention)
Title
Acceptability measure
Description
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.
Time Frame
From baseline to 12th week (at the end of intervention)
Secondary Outcome Measure Information:
Title
Suicide Attempt Self-Injury Interview
Description
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.
Time Frame
From baseline to 12th week
Title
Beck Scale for Suicide Ideation
Description
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.
Time Frame
Change in problem scores from baseline to 12th week
Title
Beck Depression Inventory
Description
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
Time Frame
Change in problem scores from baseline to 12th week
Title
Beck Hopelessness Scale
Description
This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.
Time Frame
Change in problem scores from baseline to 12th week
Title
Generalized Anxiety Disorder
Description
This is a 7-item scale used to screen for and measure severity of Generalized Anxiety Disorder.
Time Frame
Change in problem scores from baseline to 12th week
Title
Assessment of the growth and development of children
Description
Anthropometric measures of child growth will be collected through measuring children's height, weight and head circumference
Time Frame
Change from baseline to 12th week
Title
Ages and Stages Questionnaire and ASQ Socio-emotional Scales
Description
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.
Time Frame
Change from baseline to 12th week
Title
Coping resource inventory
Description
Coping resource inventory will assess the coping resources to manage stress available to an individual.
Time Frame
Change from baseline to 12th week
Title
Problem Solving Inventory
Description
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.
Time Frame
Change in problem scores from baseline to 12th week
Title
Infant Development Questionnaire
Description
Infant Development Questionnaire is a 20-item questionnaire of paternal knowledge and expectations for child development in the first three years.
Time Frame
Change from baseline to 12th week
Title
Parenting Stress Index - Short Form
Description
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.
Time Frame
Change from baseline to 12th week
Title
Multidimensional Scale of Perceived Social Support
Description
This brief scale will assess perceived social support.
Time Frame
Change from baseline to 12th week
Title
Euro-Qol-5 Dimensions scale
Description
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".
Time Frame
Change in problem scores from baseline to 12th week
Title
Client Service Receipt Inventory
Description
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
Time Frame
Change from baseline to 12th week
Title
Client Satisfaction Questionnaire
Description
The participants will rate their satisfaction with treatment using the Client Satisfaction Questionnaire.
Time Frame
Change from baseline to 12th week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Refugee mothers with children aged between 0-33 months
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tayyeba Kiran
Phone
021-36703712
Email
tayyeba.kiran@pill.org.pk
First Name & Middle Initial & Last Name or Official Title & Degree
MUQADDAS ASIF
Phone
042-35842310
Email
muqaddas.asif@pill.org.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nusrat Husain
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasim Chahudhry
Organizational Affiliation
Pakistan Institute of Living and Learning
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Settings
City
Quetta
State/Province
Balochistan
ZIP/Postal Code
87300
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sana Ullah
Facility Name
Community settings
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umair Ahsen

12. IPD Sharing Statement

Plan to Share IPD
No

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

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