Maternal DepressionROSHNINCT02047357
Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity
A study testing Learning Through Play Plus in people with Maternal Depression, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
To test the efficacy of an innovative affordable intervention program that can be used by non-specialists, including mothers and lady health workers with minimal training in low resource countries such as Pakistan Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Maternal Depression
- What is being tested?
- Learning Through Play Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 sitePakistan
- Study dates
- Dec 2013to Dec 2015
- 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
- No healthy volunteers
- 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 0-30 months
- Resident in the trial site catchments area
- Ability to complete a baseline assessment
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: Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity- A Cluster-Randomized Controlled Trial
To test the efficacy of an innovative affordable intervention program that can be used by non-specialists, including mothers and lady health workers with minimal training in low resource countries such as Pakistan
Read the detailed description
Specific challenges: In Pakistan rates of depression particularly in women are high, as well as other risks to the growth and development of young children and child mortality. Numerous studies provide compelling evidence that maternal depression not only affects mothers but is also associated with long term emotional, cognitive and behavioural problems in children. Depressed mothers are unable to provide primary care necessary for growth of their children during the first 3-years of life, a critical period for child development. Disability due to depressive symptoms (such as fatigue, poor concentration, loss of interest) is likely to affect child-care abilities directly, while impaired social functioning is likely to have indirect consequences through lack of support in childcare. Disturbances in mother-infant relationship in depressed mothers negatively influence the child's development. There is now evidence from some low income countries that effectively delivered participatory group interventions are cost effective intervention for improving maternal and child health. The Community-Based participatory Intervention LTP Plus has been designed to address maternal depression and a parenting program of child psychosocial development through mother-infant play providing stimulation, and support for exploration and autonomy for the infant.The proposed study will test the efficacy of an innovative affordable intervention program that can be used by non-specialists, including mothers and lay health workers with minimal training in low resource countries such as Pakistan.
Project Impact: LTP Plus is proposed as a low cost intervention to improve maternal mental and physical health, reduce infant and children under five years' morbidity and mortality, and promote healthy child development. Learning Through Play (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.
- Conditions
- Maternal Depression
- Being tested
- Learning Through Play Plus
- Keywords
- Maternal depression, Mother, Child, LTP, Learning Through Play, Healthy thinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning Through Play PlusOther
Also called Psycho social intervention
Learning Through Play (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 |
|---|---|---|
| Intervention Arm | Experimental | Learning Through Play Plus Receives: Other: Learning Through Play Plus |
| Control | No intervention | This arm will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPDS
The EPDS is a self-report questionnaire composed of ten items scored on a four-point scale (0-3) designed to assess pregnancy and postpartum depression Cox et al. (1987).
Measured: Change from Baseline to 3 month
Secondary outcomes (5)
Knowledge of Expectation and Child Development
A 20-item questionnaire will be used to assess maternal knowledge and expectations for child development in the first three years. A change in mothers' knowledge was reported for Pakistani mothers who participated in LTP (Rahman et al, 2009).
Measured: Baseline, 3 months and 6 months
Patient Health Questionnaire (PHQ) (Kroenke, Spitzer, Williams et al, 2001)
The Patient health Questionnaire (PHQ) is a simple 10 item self-report questionnaire can also be administered by a trained research worker. A score of 10 or more is taken as cut -off for depressive disorder
Measured: Baseline, 3 month and 6 month
Generalized Anxiety Disorder (GAD) 7 (Spitzer, R. L., Kroenke, K., Williams, J. B., & Lowe, B. 2006)
The GAD-7 is a 7 item scale used to screen for and measure severity of Genralised Anxiety Disorder. Scores of 5, 10 \& 15 are taken as cut-off points for mild, moderate and high
Measured: Baseline, 3 month and 6 month
Clinical Interview Schedule Revised (CISR)
The clinical Interview Schedule-Revised is a fully structured diagnostic instrument that was developed from an existing instrument, the Clinical Interview Schedule (CIS), assessing minor psychiatric morbidity in the community, general hospital, occupational and primary care research
Measured: Baseline, 3 month and 6 month
Quality of life (EQ 5 D)
It is a measure of health and quality of life. This is a standardised instrument for use as a measure of health outcome; it provides a simple descriptive profile and a single index value for health status.
Measured: Baseline, 3 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, The Hincks-Dellcrest Centre
- Responsible party
- Sponsor
- Investigators
- Batool Fatima, Principal investigator, Pakistan Institute of Living and LearningNancy Cohen, Ph.D, Principal investigator, The Hincks-Dellcrest Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047357
- Sponsor's protocol ID
- ROS-PILL-001
- Other IDs
- LTP-PLUS 001
- Acronym
- ROSHNI
- Status last verified
- Oct 2017
- First submitted
- 21 Jan 2014
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ashraf T, Alvi MH, Ullah A, Kiran T, Gumber A, Sikander S, Chaudhry N, Chaudhry IB, Husain N. Economic evaluation of Learning Through Play Plus in comparison to usual care for depressed mothers alongside a randomised controlled trial. BMC Health Serv Res. 2026 Feb 4;26(1):328. doi: 10.1186/s12913-026-14113-0.
PubMed 41639802
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity- A Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02047357
- Acronym / sponsor ID
- ROSHNI / ROS-PILL-001
- Conditions
- Maternal Depression
- Keywords
- Maternal depression, Mother, Child, LTP, Learning Through Play, Healthy thinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, The Hincks-Dellcrest Centre
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jan 2014 (estimated)
- 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.
To test the efficacy of an innovative affordable intervention program that can be used by non-specialists, including mothers and lady health workers with minimal training in low resource countries such as Pakistan
Detailed description
Specific challenges: In Pakistan rates of depression particularly in women are high, as well as other risks to the growth and development of young children and child mortality. Numerous studies provide compelling evidence that maternal depression not only affects mothers but is also associated with long term emotional, cognitive and behavioural problems in children. Depressed mothers are unable to provide primary care necessary for growth of their children during the first 3-years of life, a critical period for child development. Disability due to depressive symptoms (such as fatigue, poor concentration, loss of interest) is likely to affect child-care abilities directly, while impaired social functioning is likely to have indirect consequences through lack of support in childcare. Disturbances in mother-infant relationship in depressed mothers negatively influence the child's development. There is now evidence from some low income countries that effectively delivered participatory group interventions are cost effective intervention for improving maternal and child health. The Community-Based participatory Intervention LTP Plus has been designed to address maternal depression and a parenting program of child psychosocial development through mother-infant play providing stimulation, and support for exploration and autonomy for the infant.The proposed study will test the efficacy of an innovative affordable intervention program that can be used by non-specialists, including mothers and lay health workers with minimal training in low resource countries such as Pakistan.
Project Impact: LTP Plus is proposed as a low cost intervention to improve maternal mental and physical health, reduce infant and children under five years' morbidity and mortality, and promote healthy child development. Learning Through Play (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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Learning Through Play PlusLearning Through Play Plus |
| Control | No intervention | –This arm will receive no intervention |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants will be included in the study if they are:
Key exclusion criteria (4 listed)
- Participants will be excluded from the study if they have:
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 PlusAlso: Psycho social interventionLearning Through Play (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. | Other | Intervention Arm |
Primary outcome
EPDS
Time frame: Change from Baseline to 3 month
The EPDS is a self-report questionnaire composed of ten items scored on a four-point scale (0-3) designed to assess pregnancy and postpartum depression Cox et al. (1987).
5 secondary outcomes
Knowledge of Expectation and Child Development
Time frame: Baseline, 3 months and 6 months
Patient Health Questionnaire (PHQ) (Kroenke, Spitzer, Williams et al, 2001)
Time frame: Baseline, 3 month and 6 month
Generalized Anxiety Disorder (GAD) 7 (Spitzer, R. L., Kroenke, K., Williams, J. B., & Lowe, B. 2006)
Time frame: Baseline, 3 month and 6 month
Clinical Interview Schedule Revised (CISR)
Time frame: Baseline, 3 month and 6 month
Quality of life (EQ 5 D)
Time frame: Baseline, 3 month and 6 month
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 30 Oct 2017.
- Derived from this study: PubMed 41639802Ashraf T, Alvi MH, Ullah A, Kiran T, Gumber A, Sikander S, Chaudhry N, Chaudhry IB, Husain N. Economic evaluation of Learning Through Play Plus in comparison to usual care for depressed mothers alongside a randomised controlled trial. BMC Health Serv Res. 2026 Feb 4;26(1):328. doi: 10.1186/s12913-026-14113-0.
- Pakistan Institute of learning and livingLink provided by the sponsor.
Related trials for Maternal Depression
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Recruiting
Methyl Donor-Rich Diet in the Postpartum Period
Postpartum Depression (PPD), Breastfeeding
Active, not recruiting
Improving Maternal Mental Health & SUD Screening and Treatment
Mental Health Issue, Substance Use Disorders
Recruiting
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
Postpartum Depression, Postpartum Anxiety
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.
Batool Fatima principal investigator
Pakistan Institute of Living and Learning
Nancy Cohen, Ph.D principal investigator
The Hincks-Dellcrest Centre
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 Maternal Depression, 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 4 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: finished, as of the sponsor's last update on 30 Oct 2017. 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?
EPDS (time frame: Change from Baseline to 3 month). 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 NCT02047357, which also lists 1 linked publication.
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 30 Oct 2017.