Clinical trial NCT03379077: Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy for Mothers of Young Children (ROSHNI-2)
Official title: Implementing Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy (CBT) for Mothers of Young Children (0-3 Years) in Gadap Town (Roshni-2).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mothers
Keywords: Mothers
young children
Implementation
Learning through play Plus
Cognitive Behavior Therapy
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: Health and Nutrition Development Society
name: Hincks Dellcrest Centre
First posted: 2017-12-20
Enrollment: 1006
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)
timeFrame: Change from baseline at 3rd Month
Secondary outcomes:
Other outcomes:
measure: Patient Health Questionnaire (PHQ)
timeFrame: Baseline and 3rd Month
measure: Generalized Anxiety Disorder (GAD) 7
timeFrame: Baseline and 3rd Month
measure: Knowledge of Expectation and Child Development
timeFrame: Baseline and 3rd Month
measure: Parenting Stress Index - Short Form
timeFrame: Baseline and 3rd Month
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline and 3rd Month
measure: Euro-Qol-5 Dimensions (EQ-5D)
timeFrame: Baseline and 3rd Month
measure: Client Service Receipt Inventory
timeFrame: Baseline and 3rd month
measure: CSQ Client Satisfaction Questionnaire
timeFrame: 3rd Month
Locations:
city: Karachi
country: Pakistan
facility: Gadap
state: Sindh
Study officials:
affiliation: Pakistan Institute of Living & Learning
name: Nasim Chaudhry, (MRC Psych, FRC Psych, MD)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Nusrat Husain, (MD)
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Living & Learning
name: Tayyeba Kiran, MS
role: PRINCIPAL_INVESTIGATOR
References: