MothersROSHNI-2NCT03379077
Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy for Mothers of Young Children (ROSHNI-2)
A study testing LTP Plus in people with Mothers, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
The study has both quantitative and qualitative components. The objective of the quantitative study is to: Determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mothers
- What is being tested?
- LTP Plus
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,006 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Dec 2017to 28 Feb 2019
- 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 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be included in the study if they are:
- 18 to 44 years old mothers with children aged between 0-33 months, resident in the trial site catchments area, who are able to complete assessments
Who cannot join
- Participants will be excluded from the study if they have:
- A medical disorder that would prevent participation in clinical trial. Temporary resident unlikely to be available for follow up. Active suicidal ideation or any other severe or physical mental disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy (CBT) for Mothers of Young Children (0-3 Years) in Gadap Town (Roshni-2).
The study has both quantitative and qualitative components.
The objective of the quantitative study is to:
Determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme.
The objective of the qualitative study is:
Process evaluation and finding out about implementation challenges (from the perspective of the mothers and the people delivering both the LTP plus and the supported implementation intervention).
Read the detailed description
In Pakistan, the Learning through Play parenting program was tested initially through a cluster randomized study in a rural area of Pakistan. The results of this recently completed cluster RCT funded by the Grand Challenges Canada (GCC) showed that LTP Plus works and benefits both the mother and the child. More specifically, the results indicate a significant reduction in maternal depression.
Purpose of this cluster RCT is to determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme. This is an implementation trial comparing two ways of introducing LTP plus. A Cluster RCT of culturally adapted intervention LTP Plus will be conducted in the villages of Gadap town, Karachi, Pakistan. Total 60 villages will be randomized in two groups LTP plus and LTP plus supported implementation. Each cluster will be made of up to 15 mothers. Participants will be screened using eligibility checklist. Assessments will be done at baseline and after completion of intervention (3-month). All follow ups will be done by independent RAs, not involved in delivering intervention sessions.
- Conditions
- Mothers
- Being tested
- LTP Plus
- Keywords
- Mothers, young children, Implementation, Learning through play Plus, Cognitive Behavior Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTP PlusBehavioural
Also called Psycho-social Intervention
LTP Plus is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). The LTP Plus is a low-literacy, sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.
| Study group | Role | What they receive |
|---|---|---|
| LTP Plus Supported Implementation | Experimental | LTP Plus Supported Implementation group participants will receive intervention by trained LHWs of HANDS, co-facilitated and supervised by senior trained PILL researchers, expert in delivering LTP plus intervention Receives: Behavioral: LTP Plus |
| LTP Plus | Active comparator | Participants in LTP Plus arm will receive LTP plus intervention by trained LHWs of Health and Nutrition Development Society (HANDS). Receives: Behavioral: LTP Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)
This scale will be used to measure child development. Parents will report on their child's communication,gross motor, fine motor, problem solving and personal-social development.
Measured: Change from baseline at 3rd Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start20 Dec 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MothersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Nutrition Development Society, Hincks Dellcrest Centre
- Responsible party
- Sponsor
- Investigators
- Nasim Chaudhry, (MRC Psych, FRC Psych, MD), Principal investigator, Pakistan Institute of Living & LearningNusrat Husain, (MD), Principal investigator, University of ManchesterTayyeba Kiran, MS, Principal investigator, Pakistan Institute of Living & Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379077
- Sponsor's protocol ID
- PILL-ROSHNI2
- Acronym
- ROSHNI-2
- Status last verified
- Apr 2022
- First submitted
- 8 Dec 2017
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy (CBT) for Mothers of Young Children (0-3 Years) in Gadap Town (Roshni-2).
- ClinicalTrials.gov ID
- NCT03379077
- Acronym / sponsor ID
- ROSHNI-2 / PILL-ROSHNI2
- Conditions
- Mothers
- Keywords
- Mothers, young children, Implementation, Learning through play Plus, Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- Health and Nutrition Development Society, Hincks Dellcrest Centre
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 20 Dec 2017 (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.
The study has both quantitative and qualitative components.
The objective of the quantitative study is to:
Determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme.
The objective of the qualitative study is:
Process evaluation and finding out about implementation challenges (from the perspective of the mothers and the people delivering both the LTP plus and the supported implementation intervention).
Detailed description
In Pakistan, the Learning through Play parenting program was tested initially through a cluster randomized study in a rural area of Pakistan. The results of this recently completed cluster RCT funded by the Grand Challenges Canada (GCC) showed that LTP Plus works and benefits both the mother and the child. More specifically, the results indicate a significant reduction in maternal depression.
Purpose of this cluster RCT is to determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme. This is an implementation trial comparing two ways of introducing LTP plus. A Cluster RCT of culturally adapted intervention LTP Plus will be conducted in the villages of Gadap town, Karachi, Pakistan. Total 60 villages will be randomized in two groups LTP plus and LTP plus supported implementation. Each cluster will be made of up to 15 mothers. Participants will be screened using eligibility checklist. Assessments will be done at baseline and after completion of intervention (3-month). All follow ups will be done by independent RAs, not involved in delivering intervention sessions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTP Plus Supported Implementation | Experimental | Behavioral: LTP PlusLTP Plus Supported Implementation group participants will receive intervention by trained LHWs of HANDS, co-facilitated and supervised by senior trained PILL researchers, expert in delivering LTP plus intervention |
| LTP Plus | Active comparator | Behavioral: LTP PlusParticipants in LTP Plus arm will receive LTP plus intervention by trained LHWs of Health and Nutrition Development Society (HANDS). |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 44 years old mothers with children aged between 0-33 months, resident in the trial site catchments area, who are able to complete assessments
Key exclusion criteria (2 listed)
- A medical disorder that would prevent participation in clinical trial. Temporary resident unlikely to be available for follow up. Active suicidal ideation or any other severe or physical mental disorder.
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 |
|---|---|---|
| LTP PlusAlso: Psycho-social InterventionLTP Plus is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). The LTP Plus is a low-literacy, sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family. | Behavioural | LTP Plus, LTP Plus Supported Implementation |
Primary outcome
Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)
Time frame: Change from baseline at 3rd Month
This scale will be used to measure child development. Parents will report on their child's communication,gross motor, fine motor, problem solving and personal-social development.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Nasim Chaudhry, (MRC Psych, FRC Psych, MD) principal investigator
Pakistan Institute of Living & Learning
Nusrat Husain, (MD) principal investigator
University of Manchester
Tayyeba Kiran, MS principal investigator
Pakistan Institute of Living & Learning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTP Plus in people with Mothers, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009) (time frame: Change from baseline at 3rd Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2022.