Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301347
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-03-02
Brief Title:
Learning Through Play Plus for Psychosis
Sponsor:
Pakistan Institute of Living and Learning
Organization:
Pakistan Institute of Living and Learning
Study Overview
Official Title:
Integrated Parenting Intervention for Parents With Schizophrenia A Feasibility Randomized Controlled Trial in Pakistan
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None