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

Not Applicable
Completed
Conditions
Intellectual Disability
Depression
Interventions
Behavioral: LTP in My Own Way Plus
Registration Number
NCT03683706
Lead Sponsor
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
26
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionLTP in My Own Way PlusParticipants in this arm will receive 12 sessions of LTP in My Own Way Plus interventions.
Primary Outcome Measures
NameTimeMethod
Session Log (Feasibility and acceptability)change in baseline to 12 weeks

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

Secondary Outcome Measures
NameTimeMethod
Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003):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.

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

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

Trial Locations

Locations (1)

A private school in Karachi

🇵🇰

Karachi, Pakistan

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