Early Psychosocial Stimulation Program for Children of Depressed Mothers

Depression Clinical Trial

— LTP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835016
• Other study ID #: PILL-LTP-0108
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: January 2011

Study information

• Verified date: August 2019
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Maternal Depression

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Community Setting	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning	The Hincks-Dellcrest Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change in scores from baseline to 3-month and 6month
Secondary	Children's height	Height measured in cm	change in scores from baseline to 3-month and 6-month
Secondary	Children's weight	Weight measured in kgs	Change in scores from baseline to 3-month and 6-month
Secondary	Children's head circumference	Measured in cm	Change in scores from baseline to 3-month and 6-month
Secondary	Children's arm circumference	measured in cm	Change in scores from baseline to 3-month and 6-month
Secondary	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.	Change in scores from baseline to 3-month and 6-month
Secondary	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.	Change in scores from Baseline to 3-month and 6-month
Secondary	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.	Change in scores from baseline to 6-month

External Links

•   This is the link of the organization Pakistan Institute of Learning and Living which is conducting and sponsoring the research