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

This study has been completed.
Sponsor:
Collaborator:
The Hincks-Dellcrest Centre
Information provided by:
Pakistan Institute of Learning and Living
ClinicalTrials.gov Identifier:
NCT00835016
First received: February 1, 2009
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Maternal Depression
Depression
Behavioral: Early psychosocial stimulation (LTP)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Psychosocial Stimulation (LTP) Program for Children of Depressed Mothers: An RCT

Resource links provided by NLM:


Further study details as provided by Pakistan Institute of Learning and Living:

Primary Outcome Measures:
  • The primary outcome measure will be mother's score on EPDS. [ Time Frame: baseline, 3months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Children's height, weight, head and arm circumference, mother's score on HAMD, Parenting stress and mothers' knowledge and practices of childrearing measured by questionnaires [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]

Enrollment: 260
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early psychosocial stimulation (LTP)
The 10 session of Early psychosocial stimulation (LTP)will be delivered to depressed mothers in the intervention group
Behavioral: Early psychosocial stimulation (LTP)
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.
Other Names:
  • Learning Through Play
  • Psychosocial Intervention for Maternal depression
  • Randomized Control Trial
Active Comparator: Waiting 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.
Behavioral: Early psychosocial stimulation (LTP)
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.
Other Names:
  • Learning Through Play
  • Psychosocial Intervention for Maternal depression
  • Randomized Control Trial

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.

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835016

Locations
Pakistan
Pakistan Institute of Learning and Living
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Pakistan Institute of Learning and Living
The Hincks-Dellcrest Centre
Investigators
Principal Investigator: Dr. Nusrat Husain Pakistan Institute of Learning and Living
  More Information

No publications provided

Responsible Party: Dr. Nusrat Husain, Pakistan Institute of Learning and Living
ClinicalTrials.gov Identifier: NCT00835016     History of Changes
Other Study ID Numbers: PILL-LTP-0108
Study First Received: February 1, 2009
Last Updated: December 6, 2013
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Pakistan Institute of Learning and Living:
Early psychosocial stimulation, RCT, Depressed mother

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014