Learning Through Play Plus for Psychosis

NCT06301347 | Recruiting DMC

• 1 other identifier: LTP+P
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (3)

• 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)

• 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  The number participants withdrawn out of those consented to participate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).

• 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 Outcomes (15)

• Positive and Negative Syndrome Scale

  Change in scores from baseline to 3-month post-randomisation

• Psychotic Rating Scale

  Change in scores from baseline to 3-month post-randomisation

• Parenting Stress Index

  Change in scores from baseline to 3-month post-randomisation

• Maternal Attachment Inventory

  Change in scores from baseline to 3-month post-randomisation

• Knowledge attitude and practices of Child Development

  Change in scores from baseline to 3-month post-randomisation

Study Arms (2)

Learning through Play Plus

EXPERIMENTAL

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.

Behavioral: Learning through Play Plus

Treatment-as-Usual

NO INTERVENTION

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.

Interventions

Learning through Play Plus BEHAVIORAL

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

Learning through Play Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Karwan e hayat

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (4)

• 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-resource setting: Cluster randomized controlled trial. Depress Anxiety. 2021 Sep;38(9):925-939. doi: 10.1002/da.23169. Epub 2021 May 19.

  PMID: 34010505 RESULT

• 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 (RCT) of an integrated maternal psychological and early child development intervention. Asian J Psychiatr. 2017 Oct;29:63-70. doi: 10.1016/j.ajp.2017.03.010. Epub 2017 Mar 21.

  PMID: 29061430 RESULT

• 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: 10.3390/children8010026.

  PMID: 33419080 RESULT

• 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 Health Serv Res. 2017 Dec 6;17(1):808. doi: 10.1186/s12913-017-2740-z.

  PMID: 29207980 RESULT

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Tayyeba Kiran, PhD

CONTACT

0923328262142; tayyebakiran@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into one of the two treatment conditions (LTP Plus or TAU) through computer generated algorithm.

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 8, 2024
• Study Start: April 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of the trial main results
• Access Criteria: Email to corresponding author

Locations

PA (1)