Clinical trial NCT06301347: Learning Through Play Plus for Psychosis
Official title: Integrated Parenting Intervention for Parents With Schizophrenia: A Feasibility Randomized Controlled Trial in Pakistan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of the two treatment conditions (LTP Plus or TAU) through computer generated algorithm.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Change in numbers from first month of recruitment to last month of recruitment (total recruitment period is 12 months)
measure: Attrition Rate
timeFrame: Change in numbers from first month of randomisation to last month of outcome assessments (total time period is 18 months).
measure: Intervention attendance log
timeFrame: number of sessions attended by each participant in 12 month time
Secondary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Psychotic Rating Scale
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Parenting Stress Index
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Maternal Attachment Inventory
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Knowledge attitude and practices of Child Development
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Calgary Depression Scale
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Social and Occupational Functioning Scale
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Euro-Qol 5 Dimensions
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Client Service Receipt Inventory
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Ages and Stages Questionnaire
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Manchester Assessment of Caregiver-Infant Interaction
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Bayley Scale of infant development
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Child Height
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Child Weight
timeFrame: Change in scores from baseline to 3-month post-randomisation
measure: Child head circumference
timeFrame: Change in scores from baseline to 3-month post-randomisation
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Karwan e hayat
state: Sindh
Study officials:
References:
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-resource setting: Cluster randomized controlled trial. Depress Anxiety. 2021 Sep;38(9):925-939. doi: 10.1002/da.23169. Epub 2021 May 19.
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 (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.
citation: 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.
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 Health Serv Res. 2017 Dec 6;17(1):808. doi: 10.1186/s12913-017-2740-z.