Feasibility Trial of Learning Through Play (LTP) in My Own Way Plus CBT A Parent-Based Intervention for Depressed Mothers With ID Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Session Log (Feasibility and acceptability)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
Researchers doing outcome assessments will be kept blind to treatment allocations
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intervention
Participants in this arm will receive 12 sessions of LTP in My Own Way Plus interventions.
Intervention: LTP in My Own Way Plus (Behavioral)
Treatment as Usual
Participants in this arm will be getting their usual treatment
Outcomes
Primary Outcomes
Session Log (Feasibility and acceptability)
Time Frame: change in baseline to 12 weeks
sessions logs (attendance of each participant) will be maintained.
Secondary Outcomes
- 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)