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Early Psychosocial Stimulation Program for Children of Depressed Mothers (LTP)

Primary Purpose

Maternal Depression, Depression

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Early psychosocial stimulation (LTP)
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Depression focused on measuring Early psychosocial stimulation, RCT, Depressed mother

Eligibility Criteria

16 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

• All Mothers of children aged between 6-30 months having maternal depression

Exclusion Criteria:

  • 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.

Sites / Locations

  • Community Setting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early psychosocial stimulation (LTP)

Waiting group

Arm Description

The 10 session of Early psychosocial stimulation (LTP)will be delivered to depressed mothers in the intervention group

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Children's height
Height measured in cm
Children's weight
Weight measured in kgs
Children's head circumference
Measured in cm
Children's arm circumference
measured in cm
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.
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.
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.

Full Information

First Posted
February 1, 2009
Last Updated
October 9, 2020
Sponsor
Pakistan Institute of Living and Learning
Collaborators
The Hincks-Dellcrest Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00835016
Brief Title
Early Psychosocial Stimulation Program for Children of Depressed Mothers
Acronym
LTP
Official Title
Early Psychosocial Stimulation (LTP) Program for Children of Depressed Mothers: An RCT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2009 (Actual)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
Collaborators
The Hincks-Dellcrest Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression, Depression
Keywords
Early psychosocial stimulation, RCT, Depressed mother

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early psychosocial stimulation (LTP)
Arm Type
Experimental
Arm Description
The 10 session of Early psychosocial stimulation (LTP)will be delivered to depressed mothers in the intervention group
Arm Title
Waiting group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early psychosocial stimulation (LTP)
Other Intervention Name(s)
Learning Through Play, Psychosocial Intervention for Maternal depression, Randomized Control Trial
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measure will be mother's depression scores on EPDS.
Description
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
Time Frame
change in scores from baseline to 3-month and 6month
Secondary Outcome Measure Information:
Title
Children's height
Description
Height measured in cm
Time Frame
change in scores from baseline to 3-month and 6-month
Title
Children's weight
Description
Weight measured in kgs
Time Frame
Change in scores from baseline to 3-month and 6-month
Title
Children's head circumference
Description
Measured in cm
Time Frame
Change in scores from baseline to 3-month and 6-month
Title
Children's arm circumference
Description
measured in cm
Time Frame
Change in scores from baseline to 3-month and 6-month
Title
mother's depression score on Hamilton Rating Scale for Depression HAMD
Description
HAMD was used to assess severity of depression, Higher score indicates higher level of dpression.
Time Frame
Change in scores from baseline to 3-month and 6-month
Title
Mother's scores on Parenting stress Index
Description
used to assess maternal stress in their role as a parent. Higher scores indicate higher level of stress.
Time Frame
Change in scores from Baseline to 3-month and 6-month
Title
mothers' scores on knowledge, attitude and and practices Questionnaire
Description
used to assess change in maternal knowledge, attitude and practices. Higher scores indicate higher level of knowledge about child development.
Time Frame
Change in scores from baseline to 6-month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • All Mothers of children aged between 6-30 months having maternal depression Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Nusrat Husain
Organizational Affiliation
Pakistan Institute of Living and Learning
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Setting
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29061430
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.
Results Reference
derived
Links:
URL
http://pill.org.pk/
Description
This is the link of the organization Pakistan Institute of Learning and Living which is conducting and sponsoring the research

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Early Psychosocial Stimulation Program for Children of Depressed Mothers

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