Learning Through Play Plus for Psychosis

Pakistan Institute of Living and Learning

Status: Enrolling

Conditions: Psychosis

Treatments: Behavioral: Learning through Play Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT06301347

LTP+P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnostic and Statistical Manual-V (DSM-V) diagnosed first episode psychosis, schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder.
• Parents (Mother or Father), age 18 year and above
• Parents (Mother or Father) having a child from birth to 36 months
• Parents (Mother or Father) living within the catchment area of recruitment site.
• Competent and willing to give informed consent
• Parents (Mother or Father) are stable on medication for at least 3 months prior to the intervention.

Exclusion criteria

• Violation of any inclusion criteria
• Failure to perform screening or baseline examinations.
• Patients who will meet the criteria for a DSM-V diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-V alcohol or substance dependence (other than for nicotine) within the last 6 months
• Temporary resident unlikely to be available for follow up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Learning through Play Plus

Experimental group

Description:

The proposed intervention is a combination of two interventions: Learning through Play The 'Learning through Play' programme is intended to stimulate early child development. The central feature of the program is a pictorial calendar devised for parents, depicting eight successive stages of child development from birth to 3 years, with illustrations of parent-child play and other activities that promote parental involvement, learning, and attachment. Culturally Adapted Cognitive Behavioral Therapy for Psychosis (CaCBTp) The CaCBTp interventions will follow the treatment manual developed by David Kingdom and David Tarkington and culturally adapted by Farooq Naeem. In CBT the general approach will be a collaborative understanding of the development of symptoms and further work toward reducing distress and disability in participants.

Treatment:

Behavioral: Learning through Play Plus

Treatment-as-Usual

No Intervention group

Description:

This group of patients will not be provided any intervention. They will be taking only treament as usual (which in Pakistan means attending the outpatient clinic at regular intervals and taking prescribed medication) and we will compare this group with LTP Plus group after three months.