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

Primary Purpose

Intellectual Disability, Depression

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
LTP in My Own Way Plus
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Intellectual Disability

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • A private school in Karachi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Treatment as Usual

Arm Description

Participants in this arm will receive 12 sessions of LTP in My Own Way Plus interventions.

Participants in this arm will be getting their usual treatment

Outcomes

Primary Outcome Measures

Session Log (Feasibility and acceptability)
sessions logs (attendance of each participant) will be maintained.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
September 19, 2018
Last Updated
October 9, 2020
Sponsor
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT03683706
Brief Title
Learning Through Play (LTP) in My Own Way Plus CBT
Acronym
Umeed
Official Title
Feasibility Trial of Learning Through Play (LTP) in My Own Way Plus CBT A Parent-Based Intervention for Depressed Mothers With ID Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
October 8, 2020 (Actual)
Study Completion Date
October 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim of the study is to evaluate the acceptability and feasibility of LTP in My Own Way Plus with depressed mothers of ID children.
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: Help mothers cope better with their depression. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability, Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Researchers doing outcome assessments will be kept blind to treatment allocations
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive 12 sessions of LTP in My Own Way Plus interventions.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Participants in this arm will be getting their usual treatment
Intervention Type
Behavioral
Intervention Name(s)
LTP in My Own Way Plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Session Log (Feasibility and acceptability)
Description
sessions logs (attendance of each participant) will be maintained.
Time Frame
change in baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003):
Description
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.
Time Frame
change in baseline to 12 weeks
Title
Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):
Description
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
Time Frame
change in baseline to 12 weeks
Title
Vineland Adpative Behaviour Scales (VABS-II) VABS-II (Sparrow et al., 2005):
Description
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.
Time Frame
change in baseline to 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasim Chaudhry
Organizational Affiliation
Pakistan Institute of Living & Learning
Official's Role
Principal Investigator
Facility Information:
Facility Name
A private school in Karachi
City
Karachi
ZIP/Postal Code
75500
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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