Maternal DepressionLTPNCT00835016
Early Psychosocial Stimulation Program for Children of Depressed Mothers
A study testing Early psychosocial stimulation (LTP) in people with Maternal Depression and Depression, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
Aim: To assess the feasibility of provision of an early psychosocial stimulation programme for the children of depressed mothers and to determine its effect on, mothers depression , mothers' knowledge and practices of childrearing and on children's development. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Maternal Depression, Depression
- What is being tested?
- Early psychosocial stimulation (LTP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 sitePakistan
- Study dates
- Feb 2009to Jan 2011
- 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 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- All Mothers of children aged between 6-30 months having maternal depression
Who cannot join
- Subjects will not be included in the trial if they have a diagnosed medical condition or significant physical or learning disability, postpartum or other form of psychosis, or are currently under psychiatric care.
- Mothers of children with any serious medical or psychiatric illness will also be excluded.
- The age range of mothers for inclusion in the study will be 16 to 40 years, and all subjects should intend to stay in the study area for at least another 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Psychosocial Stimulation (LTP) Program for Children of Depressed Mothers: An RCT
Aim:
To assess the feasibility of provision of an early psychosocial stimulation programme for the children of depressed mothers and to determine its effect on, mothers depression , mothers' knowledge and practices of childrearing and on children's development.
Read more
Hypothesis:
Primary hypothesis:
Mothers attending the psychosocial stimulation program will have significant improvement in the level of depression as compared to the mothers who are on the waiting list.
Secondary hypothesis:
Children of mothers having the intervention will have significantly better growth than the children of mothers who do not have the intervention.
Design:
Randomised controlled trial.
Setting:
An urban slum in a township in Karachi.
Participants:
A total of 130 randomly selected depressed mothers in the intervention group and a total of 130 mothers in the waiting list control group.
Interventions:
Weekly LTP groups for the first eight sessions and two fortnightly sessions. Parenting issues will be discussed with the mothers and play activities will be demonstrated with the children using LTP and homemade materials.
Main outcome measures:
Mothers scores on EPDS \& HAM D , Parenting stress as measured by PSI-SF and mothers' knowledge and practices of child rearing measured by questionnaires. Children's height, weight, head and arm circumference.
Read the detailed description
Research findings suggest that maternal depression affects infant development and growth through multiple processes. 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 (Cooper 1999) negatively influence the infant's development. The Community-Based Multimodal Psychosocial Intervention LTP has been designed to target these processes and include a supportive component, an educational component (nutritional and healthcare advice)and a parenting programme (Childs psychosocial development through mother-infant play providing stimulation, and support for exploration and autonomy for the infant (Rahman et 2008). The objective will be to help mothers feel supported, empowered and confident about their parenting abilities, and through this process positively influence their mood. Rather than the directive approach of the medical model, health workers will be trained to adopt a more patient-centered approach, tailoring the components according to individual needs of the patient.
Further qualitative testing of the intervention will take place, This will help us to further refine the intervention package, and understand the underlying mediators (maternal mood state, levels of social support, appropriate care, etc) and moderators (education, socioeconomic status) of intervention. Some or all of these important mediators/moderators will then be later studied in detail. Detailed documentation, protocol and training-programme development for the intervention will take place in this trial.
We plan to have this intervention delivered over a three months period. Initially we will deliver weekly sessions in the first 8 weeks of recruitment. This will be followed by two fortnightly sessions in the third month. Thus making a total of 10 sessions. Each session would take up to one hour. These group sessions will be carried out at the health centre.
The trial will give an opportunity to test if the proposed intensity and duration of the intervention are acceptable to participants and to set into place mechanisms to ensure a high level of consistency with which the intervention is delivered. Feedback of performance will give an idea of how frequently refresher training is to be provided and the intervention delivery monitored. Outcome measures for the main trial and cost-effectiveness will also be tested during this phase.
The proposed pilot trial design is a single-blind study, with two parallel groups randomised individually.
- Conditions
- Maternal Depression, Depression
- Being tested
- Early psychosocial stimulation (LTP)
- Keywords
- Early psychosocial stimulation, RCT, Depressed mother
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early psychosocial stimulation (LTP)Behavioural
Also called Learning Through Play, Psychosocial Intervention for Maternal depression, Randomized Control Trial
Learning through Play (LTP) groups will be conducted weekly for the first eight sessions and two fortnightly sessions. Parenting issues will be discussed with the mothers and play activities will be demonstrated with the children using LTP and home made materials.
| Study group | Role | What they receive |
|---|---|---|
| Early psychosocial stimulation (LTP) | Experimental | The 10 session of Early psychosocial stimulation (LTP)will be delivered to depressed mothers in the intervention group Receives: Behavioral: Early psychosocial stimulation (LTP) |
| Waiting group | Active comparator | Waiting group will receive standard follow-up by their own LHWs. This group intervention will be documented at baseline, 3 months (end of the trial) and at 6 months. Similar training of Learning through Play will be provided to the mothers in this group at the end of the study. Receives: Behavioral: Early psychosocial stimulation (LTP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be mother's depression scores on EPDS.
The EPDS is a 10-item symptoms scale for postnatal depression that has been validated in the Pakistani population. Higher scores indicate higher level of depression
Measured: change in scores from baseline to 3-month and 6month
Secondary outcomes (7)
Children's height
Height measured in cm
Measured: change in scores from baseline to 3-month and 6-month
Children's weight
Weight measured in kgs
Measured: Change in scores from baseline to 3-month and 6-month
Children's head circumference
Measured in cm
Measured: Change in scores from baseline to 3-month and 6-month
Children's arm circumference
measured in cm
Measured: Change in scores from baseline to 3-month and 6-month
mother's depression score on Hamilton Rating Scale for Depression HAMD
HAMD was used to assess severity of depression, Higher score indicates higher level of dpression.
Measured: Change in scores from baseline to 3-month and 6-month
Mother's scores on Parenting stress Index
used to assess maternal stress in their role as a parent. Higher scores indicate higher level of stress.
Measured: Change in scores from Baseline to 3-month and 6-month
mothers' scores on knowledge, attitude and and practices Questionnaire
used to assess change in maternal knowledge, attitude and practices. Higher scores indicate higher level of knowledge about child development.
Measured: Change in scores from baseline to 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2010
- Study completionJan 2011
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- The Hincks-Dellcrest Centre
- Responsible party
- Sponsor
- Investigators
- Dr. Nusrat Husain, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835016
- Sponsor's protocol ID
- PILL-LTP-0108
- Acronym
- LTP
- Status last verified
- Aug 2019
- First submitted
- 1 Feb 2009
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29061430
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Psychosocial Stimulation (LTP) Program for Children of Depressed Mothers: An RCT
- ClinicalTrials.gov ID
- NCT00835016
- Acronym / sponsor ID
- LTP / PILL-LTP-0108
- Conditions
- Maternal Depression, Depression
- Keywords
- Early psychosocial stimulation, RCT, Depressed mother
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- The Hincks-Dellcrest Centre
- Study start
- Feb 2009 (actual)
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Feb 2009 (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.
Aim:
To assess the feasibility of provision of an early psychosocial stimulation programme for the children of depressed mothers and to determine its effect on, mothers depression , mothers' knowledge and practices of childrearing and on children's development.
Hypothesis:
Primary hypothesis:
Mothers attending the psychosocial stimulation program will have significant improvement in the level of depression as compared to the mothers who are on the waiting list.
Secondary hypothesis:
Children of mothers having the intervention will have significantly better growth than the children of mothers who do not have the intervention.
Design:
Randomised controlled trial.
Setting:
An urban slum in a township in Karachi.
Participants:
A total of 130 randomly selected depressed mothers in the intervention group and a total of 130 mothers in the waiting list control group.
Interventions:
Weekly LTP groups for the first eight sessions and two fortnightly sessions. Parenting issues will be discussed with the mothers and play activities will be demonstrated with the children using LTP and homemade materials.
Main outcome measures:
Mothers scores on EPDS \& HAM D , Parenting stress as measured by PSI-SF and mothers' knowledge and practices of child rearing measured by questionnaires. Children's height, weight, head and arm circumference.
Detailed description
Research findings suggest that maternal depression affects infant development and growth through multiple processes. 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 (Cooper 1999) negatively influence the infant's development. The Community-Based Multimodal Psychosocial Intervention LTP has been designed to target these processes and include a supportive component, an educational component (nutritional and healthcare advice)and a parenting programme (Childs psychosocial development through mother-infant play providing stimulation, and support for exploration and autonomy for the infant (Rahman et 2008). The objective will be to help mothers feel supported, empowered and confident about their parenting abilities, and through this process positively influence their mood. Rather than the directive approach of the medical model, health workers will be trained to adopt a more patient-centered approach, tailoring the components according to individual needs of the patient.
Further qualitative testing of the intervention will take place, This will help us to further refine the intervention package, and understand the underlying mediators (maternal mood state, levels of social support, appropriate care, etc) and moderators (education, socioeconomic status) of intervention. Some or all of these important mediators/moderators will then be later studied in detail. Detailed documentation, protocol and training-programme development for the intervention will take place in this trial.
We plan to have this intervention delivered over a three months period. Initially we will deliver weekly sessions in the first 8 weeks of recruitment. This will be followed by two fortnightly sessions in the third month. Thus making a total of 10 sessions. Each session would take up to one hour. These group sessions will be carried out at the health centre.
The trial will give an opportunity to test if the proposed intensity and duration of the intervention are acceptable to participants and to set into place mechanisms to ensure a high level of consistency with which the intervention is delivered. Feedback of performance will give an idea of how frequently refresher training is to be provided and the intervention delivery monitored. Outcome measures for the main trial and cost-effectiveness will also be tested during this phase.
The proposed pilot trial design is a single-blind study, with two parallel groups randomised individually.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early psychosocial stimulation (LTP) | Experimental | Behavioral: Early psychosocial stimulation (LTP)The 10 session of Early psychosocial stimulation (LTP)will be delivered to depressed mothers in the intervention group |
| Waiting group | Active comparator | Behavioral: Early psychosocial stimulation (LTP)Waiting group will receive standard follow-up by their own LHWs. This group intervention will be documented at baseline, 3 months (end of the trial) and at 6 months. Similar training of Learning through Play will be provided to the mothers in this group at the end of the study. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All Mothers of children aged between 6-30 months having maternal depression
Key exclusion criteria (3 listed)
- Subjects will not be included in the trial if they have a diagnosed medical condition or significant physical or learning disability, postpartum or other form of psychosis, or are currently under psychiatric care.
- Mothers of children with any serious medical or psychiatric illness will also be excluded.
- The age range of mothers for inclusion in the study will be 16 to 40 years, and all subjects should intend to stay in the study area for at least another 6 months.
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 |
|---|---|---|
| Early psychosocial stimulation (LTP)Also: Learning Through Play, Psychosocial Intervention for Maternal depression, Randomized Control TrialLearning through Play (LTP) groups will be conducted weekly for the first eight sessions and two fortnightly sessions. Parenting issues will be discussed with the mothers and play activities will be demonstrated with the children using LTP and home made materials. | Behavioural | Early psychosocial stimulation (LTP), Waiting group |
Primary outcome
The primary outcome measure will be mother's depression scores on EPDS.
Time frame: change in scores from baseline to 3-month and 6month
The EPDS is a 10-item symptoms scale for postnatal depression that has been validated in the Pakistani population. Higher scores indicate higher level of depression
7 secondary outcomes
Children's height
Time frame: change in scores from baseline to 3-month and 6-month
Children's weight
Time frame: Change in scores from baseline to 3-month and 6-month
Children's head circumference
Time frame: Change in scores from baseline to 3-month and 6-month
Children's arm circumference
Time frame: Change in scores from baseline to 3-month and 6-month
mother's depression score on Hamilton Rating Scale for Depression HAMD
Time frame: Change in scores from baseline to 3-month and 6-month
Mother's scores on Parenting stress Index
Time frame: Change in scores from Baseline to 3-month and 6-month
mothers' scores on knowledge, attitude and and practices Questionnaire
Time frame: Change in scores from baseline to 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 14 Oct 2020.
- Derived from this study: 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.
- This is the link of the organization Pakistan Institute of Learning and Living which is conducting and sponsoring the researchLink provided by the sponsor.
Related trials for Maternal Depression
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
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
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.
Dr. Nusrat Husain principal investigator
Pakistan Institute of Living and 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 Early psychosocial stimulation (LTP) in people with Maternal Depression and 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 1 inclusion and 3 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 14 Oct 2020. 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?
The primary outcome measure will be mother's depression scores on EPDS. (time frame: change in scores from baseline to 3-month and 6month). 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 NCT00835016, 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 14 Oct 2020.