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

Child Development Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05171192
• Other study ID #: SAHAR M-CMAP Plus LTP-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. (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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Child Development
• Self-harm
• Self-Injurious Behavior

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Community settings	Peshawar	KPK
Pakistan	Community Settings	Quetta	Balochistan

Sponsors (2)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning	University of Manchester

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to 12th week (at the end of intervention)
Primary	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.	From baseline to 12th week (at the end of intervention)
Secondary	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.	From baseline to 12th week
Secondary	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.	Change in problem scores from baseline to 12th week
Secondary	Beck Depression Inventory	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
Secondary	Beck Hopelessness Scale	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
Secondary	Generalized Anxiety Disorder	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
Secondary	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	Change from baseline to 12th week
Secondary	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.	Change from baseline to 12th week
Secondary	Coping resource inventory	Coping resource inventory will assess the coping resources to manage stress available to an individual.	Change from baseline to 12th week
Secondary	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.	Change in problem scores from baseline to 12th week
Secondary	Infant Development Questionnaire	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
Secondary	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.	Change from baseline to 12th week
Secondary	Multidimensional Scale of Perceived Social Support	This brief scale will assess perceived social support.	Change from baseline to 12th week
Secondary	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".	Change in problem scores from baseline to 12th week
Secondary	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	Change from baseline to 12th week
Secondary	Client Satisfaction Questionnaire	The participants will rate their satisfaction with treatment using the Client Satisfaction Questionnaire.	Change from baseline to 12th week