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

NCT05171192 | Completed DMC

• 1 other identifier: SAHAR M-CMAP Plus LTP-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Self-harm; Child Development

Keywords

Self-harm, Child development, Refugee mothers, CMAP, Learning through Play, LTP, Pakistan

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (15)

• Suicide Attempt Self-Injury Interview

  From baseline to 12th week

• Beck Scale for Suicide Ideation

  Change in problem scores from baseline to 12th week

• Beck Depression Inventory

  Change in problem scores from baseline to 12th week

• Beck Hopelessness Scale

  Change in problem scores from baseline to 12th week

• Generalized Anxiety Disorder

  Change in problem scores from baseline to 12th week

Study Arms (2)

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

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.

Interventions

CMAP Plus LTP BEHAVIORAL

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.

CMAP Plus LTP added to TAU

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Refugee mothers with children aged between 0-33 months
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• University of Manchester: collaborator

Study Sites (2)

Community Settings

Quetta, Balochistan, 87300, Pakistan

Location

Community settings

Peshawar, KPK, 25000, Pakistan

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Long-Term Potentiation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nusrat Husain

  University of Manchester

  PRINCIPAL INVESTIGATOR

• Nasim Chahudhry

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: December 28, 2021
• Study Start: April 1, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 1, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)