Early Psychosocial Stimulation Program for Children of Depressed Mothers
Condition: Maternal Depression; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): Early psychosocial stimulation (LTP)
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Learning Through Play; Psychosocial Intervention for Maternal depression; Randomized Control Trial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early psychosocial stimulation, RCT, Depressed mother