PsychosisNCT06301347
Learning Through Play Plus for Psychosis
A study testing Learning through Play Plus in people with Psychosis, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- Learning through Play Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Karwan e hayat
Karachi, Sindh
Tayyeba Kiran, PhD, 0923328262142, tayyebakiran@gmail.com
About this study
Official title: Integrated Parenting Intervention for Parents With Schizophrenia: A Feasibility Randomized Controlled Trial in Pakistan
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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- Learning through Play Plus
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning through Play PlusBehavioural
Combination of two interventions: Learning through Play and Cognitive Behaviour Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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"
Measured: number of sessions attended by each participant in 12 month time
Secondary outcomes (15)
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.
Measured: Change in scores from baseline to 3-month post-randomisation
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.
Measured: Change in scores from baseline to 3-month post-randomisation
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.
Measured: Change in scores from baseline to 3-month post-randomisation
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.
Measured: Change in scores from baseline to 3-month post-randomisation
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.
Measured: Change in scores from baseline to 3-month post-randomisation
Calgary Depression Scale
This is a depression rating scale especially developed for assessing depression in schizophrenia. Higher scores indicate higher depressive symptom severity.
Measured: Change in scores from baseline to 3-month post-randomisation
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.
Measured: Change in scores from baseline to 3-month post-randomisation
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.
Measured: Change in scores from baseline to 3-month post-randomisation
Client Service Receipt Inventory
this instrument is used to gather information about the complete spectrum of services and assistance that study participants might utilize
Measured: Change in scores from baseline to 3-month post-randomisation
Ages and Stages Questionnaire
parent-reported screening instrument comprising of 25/29 items focusing social and emotional challenges, Higher score indicate better development.
Measured: Change in scores from baseline to 3-month post-randomisation
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.
Measured: Change in scores from baseline to 3-month post-randomisation
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.
Measured: Change in scores from baseline to 3-month post-randomisation
Child Height
Child height will be assessed in centimetres
Measured: Change in scores from baseline to 3-month post-randomisation
Child Weight
Child weight will be assessed in KGs
Measured: Change in scores from baseline to 3-month post-randomisation
Child head circumference
This will be assessed in centimetres
Measured: Change in scores from baseline to 3-month post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Apr 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of the two treatment conditions (LTP Plus or TAU) through computer generated algorithm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301347
- Sponsor's protocol ID
- LTP+P
- Status last verified
- May 2024
- First submitted
- 2 Mar 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymised data will be shared with other researchers ona reasonable request to key contact person.
Publications
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.
PubMed 34010505Husain 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.
PubMed 29061430Husain 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.
PubMed 33419080Husain 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.
PubMed 29207980
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Parenting Intervention for Parents With Schizophrenia: A Feasibility Randomized Controlled Trial in Pakistan
- ClinicalTrials.gov ID
- NCT06301347
- Acronym / sponsor ID
- LTP+P
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of the two treatment conditions (LTP Plus or TAU) through computer generated algorithm.
| Arm | Type | Receives |
|---|---|---|
| Learning through Play Plus | Experimental | Behavioral: Learning through Play PlusThe 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-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learning through Play PlusCombination of two interventions: Learning through Play and Cognitive Behaviour Therapy | Behavioural | Learning through Play Plus |
Primary outcome
Recruitment Rate
Time frame: Change in numbers from first month of recruitment to last month of recruitment (total recruitment period is 12 months)
The number of parent-child dyads referred by the community health workers/treating psychiatrists, the parents who consented from all eligible parent-child dyads
Attrition Rate
Time frame: Change in numbers from first month of randomisation to last month of outcome assessments (total time period is 18 months).
The number participants withdrawn out of those consented to participate
Intervention attendance log
Time frame: number of sessions attended by each participant in 12 month time
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"
15 secondary outcomes
Positive and Negative Syndrome Scale
Time frame: Change in scores from baseline to 3-month post-randomisation
Psychotic Rating Scale
Time frame: Change in scores from baseline to 3-month post-randomisation
Parenting Stress Index
Time frame: Change in scores from baseline to 3-month post-randomisation
Maternal Attachment Inventory
Time frame: Change in scores from baseline to 3-month post-randomisation
Knowledge attitude and practices of Child Development
Time frame: Change in scores from baseline to 3-month post-randomisation
Calgary Depression Scale
Time frame: Change in scores from baseline to 3-month post-randomisation
Social and Occupational Functioning Scale
Time frame: Change in scores from baseline to 3-month post-randomisation
Euro-Qol 5 Dimensions
Time frame: Change in scores from baseline to 3-month post-randomisation
Client Service Receipt Inventory
Time frame: Change in scores from baseline to 3-month post-randomisation
Ages and Stages Questionnaire
Time frame: Change in scores from baseline to 3-month post-randomisation
Manchester Assessment of Caregiver-Infant Interaction
Time frame: Change in scores from baseline to 3-month post-randomisation
Bayley Scale of infant development
Time frame: Change in scores from baseline to 3-month post-randomisation
Child Height
Time frame: Change in scores from baseline to 3-month post-randomisation
Child Weight
Time frame: Change in scores from baseline to 3-month post-randomisation
Child head circumference
Time frame: Change in scores from baseline to 3-month post-randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Results publication: PubMed 34010505Husain 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.
- Results publication: PubMed 29061430Husain 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.
- Results publication: PubMed 33419080Husain 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.
- Results publication: PubMed 29207980Husain 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.
- Individual participant dataSharing planned: Yes. Only anonymised data will be shared with other researchers ona reasonable request to key contact person.
Related trials for Psychosis
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning through Play Plus in people with Psychosis, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tayyeba Kiran, PhD (0923328262142, tayyebakiran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Change in numbers from first month of recruitment to last month of recruitment (total recruitment period is 12 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06301347, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.