Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05171192
Study type Interventional
Source Pakistan Institute of Living and Learning
Contact
Status Active, not recruiting
Phase N/A
Start date April 1, 2022
Completion date June 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT06315036 - Effects of Developmental Gymnastics on Preschoolers' Motor Skills N/A
Active, not recruiting NCT05143294 - Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT05267730 - Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT00362076 - The Role of Motion in Infants' Ability to Categorize N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03232606 - Physical Activity of Asthmatic Children
Completed NCT05955755 - The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear N/A
Recruiting NCT04443855 - WASH Benefits Child Development Follow up N/A
Not yet recruiting NCT06335524 - Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants N/A
Not yet recruiting NCT05783141 - Prebiotic Effects in Healthy Toddlers N/A
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Completed NCT02800616 - The Healthy Elementary School of the Future N/A
Completed NCT02539251 - Arabic Ages and Stages Questionnaire-III
Completed NCT02242539 - Tools to Improve Parental Recognition of Developmental Deficits in Children N/A
Completed NCT03010306 - CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru N/A
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT00989859 - Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
Recruiting NCT00980733 - Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits Phase 3
Terminated NCT04347707 - Building Regulation in Dual Generations N/A