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

Implementing Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy (CBT) for Mothers of Young Children (0-3 Years) in Gadap Town (Roshni-2).

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).

Study Overview

• Status: Completed
• Conditions: Mothers
• Intervention / Treatment: Behavioral: LTP Plus

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.

• Study Type: Interventional
• Enrollment (Actual): 1006
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Gadap

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LTP Plus Supported Implementation; 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	Behavioral: LTP Plus; LTP Plus is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). 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 Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.; Other Names: Psycho-social Intervention
Active Comparator: LTP Plus; Participants in LTP Plus arm will receive LTP plus intervention by trained LHWs of Health and Nutrition Development Society (HANDS).	Behavioral: LTP Plus; LTP Plus is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). 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 Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.; Other Names: Psycho-social Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant development: Ages and Stages Questionnaire (Squires, Bricker, & Twombly, 2009)	This scale will be used to measure child development. Parents will report on their child's communication,gross motor, fine motor, problem solving and personal-social development.	Change from baseline at 3rd Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ)	The Patient health Questionnaire (PHQ) is a simple 10 item self-report questionnaire will also be administered by a trained research worker. A score of 10 or more is taken as cut -off for depressive disorder, however all mothers meeting eligibility criteria will be included, despite their scores on PHQ-9.	Baseline and 3rd Month
Generalized Anxiety Disorder (GAD) 7	The GAD-7 is a 7 item scale will be used to screen for and measure severity of Generalized Anxiety Disorder	Baseline and 3rd Month
Knowledge of Expectation and Child Development	A 25-item questionnaire will be used to assess maternal knowledge and expectations for child development in the first three years	Baseline and 3rd Month
Parenting Stress Index - Short Form	Parents rate 36 items on a five-point scale (1-5) on three scales: (1) Parenting Distress, (2) Difficult Child Characteristics, and (3) Dysfunctional Parent-Child Interaction.	Baseline and 3rd Month
Multidimensional Scale of Perceived Social Support (MSPSS)	This brief scale will be used to measure social support	Baseline and 3rd Month
Euro-Qol-5 Dimensions (EQ-5D)	Health-related quality of life will be measured using the EQ-5D	Baseline and 3rd Month
Client Service Receipt Inventory	We will collect information about the use of other health services (including the informal sector faith healers/Imams) using CSRI.	Baseline and 3rd month
CSQ Client Satisfaction Questionnaire	The participants will rate their satisfaction with treatment after completion of intervention using the CSQ.	3rd Month

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning
• Collaborators: Health and Nutrition Development Society; Hincks Dellcrest Centre
• Investigators: Principal Investigator: Nasim Chaudhry, (MRC Psych, FRC Psych, MD), Pakistan Institute of Living & Learning; Principal Investigator: Nusrat Husain, (MD), University of Manchester; Principal Investigator: Tayyeba Kiran, MS, Pakistan Institute of Living & Learning

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Implementation; young children; Cognitive Behavior Therapy; Mothers; Learning through play Plus
• Other Study ID Numbers: PILL-ROSHNI2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No