Learning Through Play (LTP) in My Own Way Plus CBT (Umeed)

Feasibility Trial of Learning Through Play (LTP) in My Own Way Plus CBT A Parent-Based Intervention for Depressed Mothers With ID Children

Aim of the study is to evaluate the acceptability and feasibility of LTP in My Own Way Plus with depressed mothers of ID children.

Study Overview

• Status: Completed
• Conditions: Depression; Intellectual Disability
• Intervention / Treatment: Behavioral: LTP in My Own Way Plus

Detailed Description

Having a child with a chronic medical problem or an intellectual disability increases anxiety and depression in parents. There is some growing evidence that families of ID children are able to meet the challenges. The purpose of the present study is to adapt LTP in my own way plus to test its acceptability and determine if it improves mothers knowledge about their child development and reduce their level of distress.

The study has two phases: quantitative phase and qualitative phase. Quantitative phase: A single blind randomised controlled trial in school settings in Karachi Pakistan.

Objectives:

1. Help mothers cope better with their depression.
2. Teach mothers play activities that will stimulate their children's development and improve mother-child interaction.

Qualitative Phase: This will help to determine acceptability of the intervention and identify perceived mechanisms of change and any barriers and facilitators to LTP in my own Plus intervention. In-depth digitally recorded interviews and focus groups will be conducted with the parents and teachers to understand their beliefs, views, and feelings about caring for ID children.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan, 75500
    • A private school in Karachi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Mothers of ID children aged 3 to 6 years, screened positive for depression
• Ability to complete a baseline assessment
• Ability to communicate in Urdu or English

Exclusion Criteria:

• Have a diagnosed serious medical or psychiatric condition
• Mothers of children with other medical illness
• Temporary residents unlikely to be available for follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Participants in this arm will receive 12 sessions of LTP in My Own Way Plus interventions.	Behavioral: LTP in My Own Way Plus; LTP in My Own Way Plus is a 12-session integrated intervention-Learning through Play in My Own Way Plus Cognitive Behaviour Therapy (CBT). LTP in My Own Way is the extension of the parent education program called 'Learning Through Play' developed by Toronto Public Health (1993) revised by The Hincks-Dellcrest Centre (2000). LTP aims for the healthy growth of young children (birth to 6 years) using the stages of development incorporating Piaget's theory of cognitive development and Bowlby's theory of attachment. The objective of this program is to strengthen parent-child attachment by encouraging parental involvement and teaching parents how to use play activities to enhance their children's development. Second component of intervention is CBT adapted from Jeanne Miranda manual (Group CBT for Depression, group leaders guide book-2006) focusing on the three areas: thoughts and your mood, activities and your mood, people interaction and your mood.
No Intervention: Treatment as Usual; Participants in this arm will be getting their usual treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Session Log (Feasibility and acceptability)	sessions logs (attendance of each participant) will be maintained.	change in baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003):	The Patient health Questionnaire (PHQ-9) is 10 items self-report questionnaire for screening, diagnosing and measuring severity of depression which is easy to use and can be administered by a trained research worker. Score ranges from 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.	change in baseline to 12 weeks
Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):	The GAD-7 is a 7-item scale used to screen for and measure severity of generalized anxiety disorder. Scores of 5, 10 & 15 are taken as cut-off points for mild, moderate and high. it takes about 5 minutes to administer this sca	change in baseline to 12 weeks
Vineland Adpative Behaviour Scales (VABS-II) VABS-II (Sparrow et al., 2005):	VABS-II measure adaptive behaviors of individuals from birth to 90 years. The main domains are communication, daily living skills, socialization, and motor skills. The parent/caregiver self-report form requires a completion time of 30-60 minutes and yields an adaptive behaviour composite score.	change in baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning
• Investigators: Principal Investigator: Nasim Chaudhry, Pakistan Institute of Living & Learning

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): October 8, 2020
• Study Completion (Actual): October 8, 2020

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 22, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: LTP In My Own Way Plus

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