deltatrials
Completed NA INTERVENTIONAL 2-arm NCT00835016

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

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

Sponsor: Pakistan Institute of Living and Learning

Updated 8 times since 2017 Last updated: Oct 9, 2020 Started: Feb 28, 2009 Primary completion: Jul 31, 2010 Completion: Jan 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00835016, this NA trial focuses on Depression and Maternal Depression and remains completed. Sponsored by Pakistan Institute of Living and Learning, it has been updated 8 times since 2009, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Study Description(click to expand)

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)...

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Sep 2019 · 15 months · monthly snapshotCompleted~Sep 2019 – ~Nov 2020 · 14 months · monthly snapshotCompleted~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. Jan 2021 — Jul 2024 [monthly]

    Completed NA

  5. Nov 2020 — Jan 2021 [monthly]

    Completed NA

Show 3 earlier versions
  1. Sep 2019 — Nov 2020 [monthly]

    Completed NA

    Phase: PHASE2NA

  2. Jun 2018 — Sep 2019 [monthly]

    Completed PHASE2

  3. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Feb 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pakistan Institute of Living and Learning
  • The Hincks-Dellcrest Centre
Data source: Pakistan Institute of Living and Learning

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations