Clinical trial NCT05171192: 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
Overall status: COMPLETED
Phase: NA
Conditions: Self-harm
Child Development
Keywords: Self-harm, Child development, Refugee mothers, CMAP, Learning through Play, LTP, Pakistan
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2021-12-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility measure
timeFrame: From baseline to 12th week (at the end of intervention)
measure: Acceptability measure
timeFrame: From baseline to 12th week (at the end of intervention)
Secondary outcomes:
measure: Suicide Attempt Self-Injury Interview
timeFrame: From baseline to 12th week
measure: Beck Scale for Suicide Ideation
timeFrame: Change in problem scores from baseline to 12th week
measure: Beck Depression Inventory
timeFrame: Change in problem scores from baseline to 12th week
measure: Beck Hopelessness Scale
timeFrame: Change in problem scores from baseline to 12th week
measure: Generalized Anxiety Disorder
timeFrame: Change in problem scores from baseline to 12th week
measure: Assessment of the growth and development of children
timeFrame: Change from baseline to 12th week
measure: Ages and Stages Questionnaire and ASQ Socio-emotional Scales
timeFrame: Change from baseline to 12th week
measure: Coping resource inventory
timeFrame: Change from baseline to 12th week
measure: Problem Solving Inventory
timeFrame: Change in problem scores from baseline to 12th week
measure: Infant Development Questionnaire
timeFrame: Change from baseline to 12th week
measure: Parenting Stress Index - Short Form
timeFrame: Change from baseline to 12th week
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Change from baseline to 12th week
measure: Euro-Qol-5 Dimensions scale
timeFrame: Change in problem scores from baseline to 12th week
measure: Client Service Receipt Inventory
timeFrame: Change from baseline to 12th week
measure: Client Satisfaction Questionnaire
timeFrame: Change from baseline to 12th week
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: Community Settings
state: Balochistan
city: Peshawar
country: Pakistan
facility: Community settings
state: KPK
Study officials:
affiliation: University of Manchester
name: Nusrat Husain
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Living and Learning
name: Nasim Chahudhry
role: PRINCIPAL_INVESTIGATOR
References: