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Completed

NCT Number: NCT03683706

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

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

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Key information

Conditions

Intellectual Disability Behavior Behavioral Symptoms Depression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

A private school in Karachi

Karachi, 75500, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LTP in My Own Way Plus

Behavioral

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 outcomes

  1. Session Log (Feasibility and acceptability)

    Time frame: change in baseline to 12 weeks

    sessions logs (attendance of each participant) will be maintained.

Secondary outcomes

  1. Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003):

    Time frame: change in baseline to 12 weeks

    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.

  2. Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):

    Time frame: change in baseline to 12 weeks

    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

  3. Vineland Adpative Behaviour Scales (VABS-II) VABS-II (Sparrow et al., 2005):

    Time frame: change in baseline to 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Official study title

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

Acronym: Umeed

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2018
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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