Early Psychosocial Stimulation Program for Children of Depressed Mothers

NCT00835016 | Completed

• 1 other identifier: PILL-LTP-0108
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Depression; Depression

Keywords

Early psychosocial stimulation, RCT, Depressed mother

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Children's height

  change in scores from baseline to 3-month and 6-month

• Children's weight

  Change in scores from baseline to 3-month and 6-month

• Children's head circumference

  Change in scores from baseline to 3-month and 6-month

• Children's arm circumference

  Change in scores from baseline to 3-month and 6-month

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

  Change in scores from baseline to 3-month and 6-month

Study Arms (2)

Early psychosocial stimulation (LTP)

EXPERIMENTAL

The 10 session of Early psychosocial stimulation (LTP)will be delivered to depressed mothers in the intervention group

Behavioral: Early psychosocial stimulation (LTP)

Waiting group

ACTIVE COMPARATOR

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)

Interventions

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.

Also known as: Learning Through Play, Psychosocial Intervention for Maternal depression, Randomized Control Trial

Early psychosocial stimulation (LTP); Waiting group

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All Mothers of children aged between 6-30 months having maternal depression

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• The Hincks-Dellcrest Centre: collaborator

Study Sites (1)

Community Setting

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 29061430 DERIVED

Related Links

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

MeSH Terms

Conditions

Depression

Interventions

Long-Term Potentiation; Psychosocial Intervention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dr. Nusrat Husain

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2009
• First Posted: February 3, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2011
• Last Updated: October 14, 2020

Record last verified: 2019-08

Locations

PA (1)