NCT03430622

Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT)

Telephone Delivered Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT) for Depressed Mothers - A Multicentre Randomized Controlled Trial (RCT) in a Low-Income Country

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal depression.

Detailed description

Despite the high prevalence of maternal depression in Pakistan, research on psychosocial interventions is limited. We will test the effectiveness of a telephone based intervention program called Learning through Play plus Interpersonal Psychotherapy (LTP Plus) that can be used by non-specialists, including trained graduates, mothers and lay health workers with minimal training. This telephone communication will be supplemented by the provision of LTP Plus pictorial calendars to the depressed mothers. Purpose of this RCT is to determine if telephone delivered intervention of the LTP plus programme reduces symptoms of maternal depression and improves infant development compared to Treatment as usual. A sample of 354 (177 in each group) will be required. The study will be conducted in big cities of Pakistan including Karachi, Lahore, Hyderabad, Nawabshah, Quetta and Peshawar.Participants will be screened using Patient Health Questionnaire (PHQ-9) and eligibility checklist. Those scoring 10 and above on PHQ-9 will be invited to participate in the study. Assessments will be done at baseline and after completion of intervention (3rd month and 6th month after randomization). All follow ups will be done by independent Research Assistants (RAs), blind to the treatment allocations.

Conditions

• Maternal Depression

Interventions

Type	Name	Description
BEHAVIORAL	LTP Plus	LTP Plus is comprised of two components; Learning through play (LTP) and Interpersonal Psychotherapy (IPT). The LTP Plus is a low-literacy; sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Interpersonal Psychotherapy (IPT) intervention is comprised of a supportive element, an educational element, a parenting element and an interpersonal relationship element. Intervention goals include helping mothers feel supported, empowered and confident about their parenting abilities, which would directly influence reduction in depressive symptoms as well as resolution of interpersonal conflicts.
OTHER	TAU	This group will be on their routine care and will not be given any intervention

Timeline

• Start date: 2018-02-20
• Primary completion: 2019-08-20
• Completion: 2019-08-30
• First posted: 2018-02-13
• Last updated: 2021-07-13

Locations

6 sites across 1 country: Pakistan