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

Mothers Clinical Trial

— 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379077
• Other study ID #: PILL-ROSHNI2
• Status: Completed
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2022
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1006
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mothers

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.

Locations

Country	Name	City	State
Pakistan	Gadap	Karachi	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning	Health and Nutrition Development Society, Hincks Dellcrest Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Multidimensional Scale of Perceived Social Support (MSPSS)	This brief scale will be used to measure social support	Baseline and 3rd Month
Other	Euro-Qol-5 Dimensions (EQ-5D)	Health-related quality of life will be measured using the EQ-5D	Baseline and 3rd Month
Other	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
Other	CSQ Client Satisfaction Questionnaire	The participants will rate their satisfaction with treatment after completion of intervention using the CSQ.	3rd Month
Primary	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