Learning Through Play Plus for Psychosis

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301347
• Other study ID #: LTP+P
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Pakistan Institute of Living and Learning
• Contact: Tayyeba Kiran, PhD
• Phone: 0923328262142
• Email: tayyebakiran[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Learning through Play Plus
Combination of two interventions: Learning through Play and Cognitive Behaviour Therapy

Locations

Country	Name	City	State
Pakistan	Karwan e hayat	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Husain MI, Chaudhry IB, Khoso AB, Wan MW, Kiran T, Shiri T, Chaudhry N, Mehmood N, Jafri SF, Naeem F, Husain N. A Group Parenting Intervention for Depressed Fathers (LTP + Dads): A Feasibility Study from Pakistan. Children (Basel). 2021 Jan 6;8(1):26. doi — View Citation

Husain MO, Chaudhry IB, Mehmood N, Rehman RU, Kazmi A, Hamirani M, Kiran T, Bukhsh A, Bassett P, Husain MI, Naeem F, Husain N. Pilot randomised controlled trial of culturally adapted cognitive behavior therapy for psychosis (CaCBTp) in Pakistan. BMC Healt — View Citation

Husain N, Kiran T, Fatima B, Chaudhry IB, Husain M, Shah S, Bassett P, Cohen N, Jafri F, Naeem S, Zadeh Z, Roberts C, Rahman A, Naeem F, Husain MI, Chaudhry N. An integrated parenting intervention for maternal depression and child development in a low-res — View Citation

Husain N, Zulqernain F, Carter LA, Chaudhry IB, Fatima B, Kiran T, Chaudhry N, Naeem S, Jafri F, Lunat F, Haq SU, Husain M, Roberts C, Naeem F, Rahman A. Treatment of maternal depression in urban slums of Karachi, Pakistan: A randomized controlled trial ( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	The number of parent-child dyads referred by the community health workers/treating psychiatrists, the parents who consented from all eligible parent-child dyads	Change in numbers from first month of recruitment to last month of recruitment (total recruitment period is 12 months)
Primary	Attrition Rate	The number participants withdrawn out of those consented to participate	Change in numbers from first month of randomisation to last month of outcome assessments (total time period is 18 months).
Primary	Intervention attendance log	This log will be maintained to assess the acceptability of the intervention is defined as "the extent participant receiving the intervention consider it to be appropriate"	number of sessions attended by each participant in 12 month time
Secondary	Positive and Negative Syndrome Scale	This is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale. Higher score indicates more severe psychopathology.	Change in scores from baseline to 3-month post-randomisation
Secondary	Psychotic Rating Scale	This scale rates features such as frequency, intensity, and interference of hallucinations and delusions on a 4-point scale. Higher score indicates more severe psychopathology.	Change in scores from baseline to 3-month post-randomisation
Secondary	Parenting Stress Index	This is a a five-point scale to assess (1) Parenting Distress, (2) Difficult Child Characteristics, and (3) Dysfunctional Parent-Child Interaction. Higher score indicates higher intensity of parenting stress.	Change in scores from baseline to 3-month post-randomisation
Secondary	Maternal Attachment Inventory	A 26-item scale will be used to ask respondents to indicate how they generally feel in relation to thoughts (e.g. 'My thoughts are full of my baby'), feelings (e.g. 'I feel love for my baby') and situations (e.g. 'I watch my baby sleep') new mothers may experience. Higer score indicate greater level of maternal attachment.	Change in scores from baseline to 3-month post-randomisation
Secondary	Knowledge attitude and practices of Child Development	A 20-item questionnaire will be used to assess maternal knowledge and expectations for child development in the first three years. Higher score indicate better knowledge about child development.	Change in scores from baseline to 3-month post-randomisation
Secondary	Calgary Depression Scale	This is a depression rating scale especially developed for assessing depression in schizophrenia. Higher scores indicate higher depressive symptom severity.	Change in scores from baseline to 3-month post-randomisation
Secondary	Social and Occupational Functioning Scale	It is a global rating of current functioning; this instrument focuses on social and occupational functioning that is independent of the overall severity of the individual's psychological symptoms. Higher score indicate better functioning.	Change in scores from baseline to 3-month post-randomisation
Secondary	Euro-Qol 5 Dimensions	A standardized tool assessing the five health related quality of life aspects such as mobility, self-care, typical activates, pain and discomfort and anxiety/depression. Higher score indicate better quality of life.	Change in scores from baseline to 3-month post-randomisation
Secondary	Client Service Receipt Inventory	this instrument is used to gather information about the complete spectrum of services and assistance that study participants might utilize	Change in scores from baseline to 3-month post-randomisation
Secondary	Ages and Stages Questionnaire	parent-reported screening instrument comprising of 25/29 items focusing social and emotional challenges, Higher score indicate better development.	Change in scores from baseline to 3-month post-randomisation
Secondary	Manchester Assessment of Caregiver-Infant Interaction	Six-minute videos of caregiver-infant interaction will be evaluated for a subset of participants by a trained, reliable rater on 7 MACI scales which globally assess core characteristics of caregiver-infant play interaction on a 7-point scale. Higher score indicate better interaction.	Change in scores from baseline to 3-month post-randomisation
Secondary	Bayley Scale of infant development	Bayley Scale will be administered on a subset of participants to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infant and toddlers, ages 0-3. Higher score indicate better development.	Change in scores from baseline to 3-month post-randomisation
Secondary	Child Height	Child height will be assessed in centimetres	Change in scores from baseline to 3-month post-randomisation
Secondary	Child Weight	Child weight will be assessed in KGs	Change in scores from baseline to 3-month post-randomisation
Secondary	Child head circumference	This will be assessed in centimetres	Change in scores from baseline to 3-month post-randomisation