Clinical trial NCT00835016: Early Psychosocial Stimulation Program for Children of Depressed Mothers
Official title: Early Psychosocial Stimulation (LTP) Program for Children of Depressed Mothers: An RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Depression
Depression
Keywords: Early psychosocial stimulation, RCT, Depressed mother
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: The Hincks-Dellcrest Centre
First posted: 2009-02-03
Enrollment: 260
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The primary outcome measure will be mother's depression scores on EPDS.
timeFrame: change in scores from baseline to 3-month and 6month
Secondary outcomes:
measure: Children's height
timeFrame: change in scores from baseline to 3-month and 6-month
measure: Children's weight
timeFrame: Change in scores from baseline to 3-month and 6-month
measure: Children's head circumference
timeFrame: Change in scores from baseline to 3-month and 6-month
measure: Children's arm circumference
timeFrame: Change in scores from baseline to 3-month and 6-month
measure: mother's depression score on Hamilton Rating Scale for Depression HAMD
timeFrame: Change in scores from baseline to 3-month and 6-month
measure: Mother's scores on Parenting stress Index
timeFrame: Change in scores from Baseline to 3-month and 6-month
measure: mothers' scores on knowledge, attitude and and practices Questionnaire
timeFrame: Change in scores from baseline to 6-month
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Community Setting
state: Sindh
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Dr. Nusrat Husain
role: PRINCIPAL_INVESTIGATOR
References:
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.