NCT06301347

Learning Through Play Plus for Psychosis

Integrated Parenting Intervention for Parents With Schizophrenia: A Feasibility Randomized Controlled Trial in Pakistan

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. This may cause insecure attachment in infants of mothers with psychosis. Children of parents with schizophrenia have poor developmental and clinical outcomes. However, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. Learning through Play (LTP) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. The proposed study will integrate LTP with existing culturally appropriate Cognitive Behaviour Theray (CBT) for psychosis (CaCBT-p) and test its feasibility and acceptability for parents with schizophrenia.

Detailed description

Objectives * To determine whether the proposed intervention is acceptable to the parents with schizophrenia. * To assess the feasibility of proposed intervention for target population (no of sessions attended, content, duration and location, uptake and retention). * To determine most suitable outcome measures for future randomized controlled trial. * To identify any barriers in recruitment of participants. Recruiting up to 75% of total sample will be a success criteria. Methods Design: Mixed method feasibility Randomised Controlled Trial Study Sites The participants will be recruited from outpatient departments of psychiatry and community settings in 7 cities of Pakistan i.e. Karachi, Hyderabad, Lahore, Rawalpindi, Multan, Peshawar and Quetta. Sample Size: A total of 90 individuals (45 in each arm) meeting the eligibility criteria will be recruited to participate in the study from different psychiatric units. Randomization Participants will be randomized into one of the two treatment conditions (LTP Plus or TAU) through computer generated algorithm.

Conditions

• Psychosis

Interventions

Type	Name	Description
BEHAVIORAL	Learning through Play Plus	Combination of two interventions: Learning through Play and Cognitive Behaviour Therapy

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-04-30
• Completion: 2025-12-30
• First posted: 2024-03-08
• Last updated: 2024-05-17

Locations

1 site across 1 country: Pakistan