Self-harmNCT05171192
Culturally Adapted CMAP Plus LTP for Refugee Mothers with History of Self-harm in Pakistan
A study testing CMAP Plus LTP in people with Self-harm and Child Development, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Self-harm, Child Development
- What is being tested?
- CMAP Plus LTP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Apr 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to provide consent due to severe mental or physical illness.
- Unlikely to be available for the entire duration of the study.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Community settings
Peshawar, KPK, 25000
Community Settings
Quetta, Balochistan, 87300
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Self-harm, Child Development
- Being tested
- CMAP Plus LTP
- Keywords
- Self-harm, Child development, Refugee mothers, CMAP, Learning through Play, LTP, Pakistan
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMAP Plus LTPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CMAP Plus LTP added to TAU | Experimental | 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 Receives: Behavioral: CMAP Plus LTP |
| TAU alone | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 12th week (at the end of intervention)
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.
Measured: From baseline to 12th week (at the end of intervention)
Secondary outcomes (15)
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.
Measured: From baseline to 12th week
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.
Measured: Change in problem scores from baseline to 12th week
Beck Depression Inventory
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
Measured: Change in problem scores from baseline to 12th week
Beck Hopelessness Scale
This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.
Measured: Change in problem scores from baseline to 12th week
Generalized Anxiety Disorder
This is a 7-item scale used to screen for and measure severity of Generalized Anxiety Disorder.
Measured: Change in problem scores from baseline to 12th week
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
Measured: Change from baseline to 12th week
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.
Measured: Change from baseline to 12th week
Coping resource inventory
Coping resource inventory will assess the coping resources to manage stress available to an individual.
Measured: Change from baseline to 12th week
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.
Measured: Change in problem scores from baseline to 12th week
Infant Development Questionnaire
Infant Development Questionnaire is a 20-item questionnaire of paternal knowledge and expectations for child development in the first three years.
Measured: Change from baseline to 12th week
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.
Measured: Change from baseline to 12th week
Multidimensional Scale of Perceived Social Support
This brief scale will assess perceived social support.
Measured: Change from baseline to 12th week
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".
Measured: Change in problem scores from baseline to 12th week
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
Measured: Change from baseline to 12th week
Client Satisfaction Questionnaire
The participants will rate their satisfaction with treatment using the Client Satisfaction Questionnaire.
Measured: Change from baseline to 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Apr 2022
- Primary completion15 Dec 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-harmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Nusrat Husain, Principal investigator, University of ManchesterNasim Chahudhry, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171192
- Sponsor's protocol ID
- SAHAR M-CMAP Plus LTP-002
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05171192
- Acronym / sponsor ID
- SAHAR M-CMAP Plus LTP-002
- Conditions
- Self-harm, Child Development
- Keywords
- Self-harm, Child development, Refugee mothers, CMAP, Learning through Play, LTP, Pakistan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMAP Plus LTP added to TAU | Experimental | Behavioral: CMAP Plus LTPC-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 | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable to provide consent due to severe mental or physical illness.
- Unlikely to be available for the entire duration of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMAP Plus LTPThe 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. | Behavioural | CMAP Plus LTP added to TAU |
Primary outcome
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.
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.
15 secondary outcomes
Suicide Attempt Self-Injury Interview
Time frame: From baseline to 12th week
Beck Scale for Suicide Ideation
Time frame: Change in problem scores from baseline to 12th week
Beck Depression Inventory
Time frame: Change in problem scores from baseline to 12th week
Beck Hopelessness Scale
Time frame: Change in problem scores from baseline to 12th week
Generalized Anxiety Disorder
Time frame: 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
Ages and Stages Questionnaire and ASQ Socio-emotional Scales
Time frame: Change from baseline to 12th week
Coping resource inventory
Time frame: Change from baseline to 12th week
Problem Solving Inventory
Time frame: Change in problem scores from baseline to 12th week
Infant Development Questionnaire
Time frame: Change from baseline to 12th week
Parenting Stress Index - Short Form
Time frame: Change from baseline to 12th week
Multidimensional Scale of Perceived Social Support
Time frame: Change from baseline to 12th week
Euro-Qol-5 Dimensions scale
Time frame: Change in problem scores from baseline to 12th week
Client Service Receipt Inventory
Time frame: Change from baseline to 12th week
Client Satisfaction Questionnaire
Time frame: Change from baseline to 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Self-harm
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
SERENE Low-Intensity Focused Ultrasound for Cognitive Control
Suicidal Ideation, Cognitive Control
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nusrat Husain principal investigator
University of Manchester
Nasim Chahudhry principal investigator
Pakistan Institute of Living and Learning
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMAP Plus LTP in people with Self-harm and Child Development, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measure (time frame: From baseline to 12th week (at the end of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.