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Completed

NCT Number: NCT00835016

Early Psychosocial Stimulation Program for Children of Depressed Mothers

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.

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Key information

Age range

16 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Community Setting

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early psychosocial stimulation (LTP)

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Children's height

    Time frame: change in scores from baseline to 3-month and 6-month

    Height measured in cm

  2. Children's weight

    Time frame: Change in scores from baseline to 3-month and 6-month

    Weight measured in kgs

  3. Children's head circumference

    Time frame: Change in scores from baseline to 3-month and 6-month

    Measured in cm

  4. Children's arm circumference

    Time frame: Change in scores from baseline to 3-month and 6-month

    measured in cm

  5. mother's depression score on Hamilton Rating Scale for Depression HAMD

    Time frame: Change in scores from baseline to 3-month and 6-month

    HAMD was used to assess severity of depression, Higher score indicates higher level of dpression.

  6. Mother's scores on Parenting stress Index

    Time frame: Change in scores from Baseline to 3-month and 6-month

    used to assess maternal stress in their role as a parent. Higher scores indicate higher level of stress.

  7. mothers' scores on knowledge, attitude and and practices Questionnaire

    Time frame: Change in scores from baseline to 6-month

    used to assess change in maternal knowledge, attitude and practices. Higher scores indicate higher level of knowledge about child development.

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • The Hincks-Dellcrest Centre

Registry information

Official study title

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

Acronym: LTP

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Feb 3, 2009
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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