Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy for Mothers of Young Children (ROSHNI-2)

Pakistan Institute of Living and Learning

Status: Completed

Conditions: Mothers

Treatments: Behavioral: LTP Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT03379077

PILL-ROSHNI2

Details and patient eligibility

About

The study has both quantitative and qualitative components.

The objective of the quantitative study is to:

Determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme.

The objective of the qualitative study is:

Process evaluation and finding out about implementation challenges (from the perspective of the mothers and the people delivering both the LTP plus and the supported implementation intervention).

Full description

In Pakistan, the Learning through Play parenting program was tested initially through a cluster randomized study in a rural area of Pakistan. The results of this recently completed cluster RCT funded by the Grand Challenges Canada (GCC) showed that LTP Plus works and benefits both the mother and the child. More specifically, the results indicate a significant reduction in maternal depression.

Purpose of this cluster RCT is to determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme. This is an implementation trial comparing two ways of introducing LTP plus. A Cluster RCT of culturally adapted intervention LTP Plus will be conducted in the villages of Gadap town, Karachi, Pakistan. Total 60 villages will be randomized in two groups LTP plus and LTP plus supported implementation. Each cluster will be made of up to 15 mothers. Participants will be screened using eligibility checklist. Assessments will be done at baseline and after completion of intervention (3-month). All follow ups will be done by independent RAs, not involved in delivering intervention sessions.

Enrollment: 1,006 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Participants will be included in the study if they are:

18 to 44 years old mothers with children aged between 0-33 months, resident in the trial site catchments area, who are able to complete assessments

Exclusion criteria

Participants will be excluded from the study if they have:

A medical disorder that would prevent participation in clinical trial. Temporary resident unlikely to be available for follow up. Active suicidal ideation or any other severe or physical mental disorder.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,006 participants in 2 patient groups

LTP Plus Supported Implementation

Experimental group

Description:

LTP Plus Supported Implementation group participants will receive intervention by trained LHWs of HANDS, co-facilitated and supervised by senior trained PILL researchers, expert in delivering LTP plus intervention

Treatment:

Behavioral: LTP Plus

LTP Plus

Active Comparator group

Description:

Participants in LTP Plus arm will receive LTP plus intervention by trained LHWs of Health and Nutrition Development Society (HANDS).

Treatment:

Behavioral: LTP Plus