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

To Investigate the Feasibility and Acceptability of an Innovative, Intervention 'LTP in My in my Own Way Plus' With Depressed Mothers of Children With Intellectual Disability (DS) .

Sponsors

Lead Sponsor: Pakistan Institute of Living and Learning

Source Pakistan Institute of Living and Learning
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:

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.

Overall Status Recruiting
Start Date March 15, 2019
Completion Date December 2020
Primary Completion Date December 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Session Log (Feasibility and acceptability) change in baseline to 12 weeks
Secondary Outcome
Measure Time Frame
Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003): change in baseline to 12 weeks
Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006): change in baseline to 12 weeks
Vineland Adpative Behaviour Scales (VABS-II) VABS-II (Sparrow et al., 2005): change in baseline to 12 weeks
Enrollment 24
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: LTP in My Own Way Plus

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.

Arm Group Label: Intervention

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Nasim Chaudhry Principal Investigator Pakistan Institute of Living & Learning
Overall Contact

Last Name: Ameer B Khoso, Mphil

Phone: 0213-5871845

Email: [email protected]

Location
Facility: Status: Contact: A private school in Karachi Sobia Hidayatullah
Location Countries

Pakistan

Verification Date

August 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention

Type: Active Comparator

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

Label: Treatment as Usual

Type: No Intervention

Description: Participants in this arm will be getting their usual treatment

Acronym Umeed
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Health Services Research

Masking: Single (Outcomes Assessor)

Masking Description: Researchers doing outcome assessments will be kept blind to treatment allocations

Source: ClinicalTrials.gov