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

Pakistan Institute of Living and Learning

Status: Completed

Conditions: Child Development; Self-harm

Treatments: Behavioral: CMAP Plus LTP

Study type: Interventional

Funder types: Other

Identifiers

NCT05171192

SAHAR M-CMAP Plus LTP-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

CMAP Plus LTP added to TAU

Experimental group

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

Treatment:

Behavioral: CMAP Plus LTP

TAU alone

No Intervention group

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.