- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05574569
Cognitive Behavior Play Therapy and Culturally Adapted Mindfulness-Based Guided Self-Help for Parents
Effect of Cognitive Behavior Play Therapy and Culturally Adapted Mindfulness-Based Guided Self-Help for Parents of Children With Emotional and Behavioral Problems
Study Overview
Status
Conditions
Detailed Description
There is a high prevalence of emotional and behavioral problems globally and a similar is reported in the children of Pakistan, in a study conducted in Karachi. However, despite the alarming situation created by this problem, there is a need of developing culturally adapted approaches due to differences from western culture, where these therapies have been developed and used first. In this context, this study is planned to find out the effect of Cognitive Behavior Play Therapy and Culturally Adapted Mindfulness-based guided self-help for parents of children with Emotional and Behavioral Problems.
The study will be carried out using mixed methods; quantitative and qualitative. The qualitative part will consist of a structured interview with a minimum of 10-15 parents, and mental health professionals, respectively, using the interview questionnaires. The data will be analyzed by systematic content and question analysis which will identify the emerging themes and categories. The data will then be reorganized into wider themes, codes, and categories and written for guidelines to culturally adapt the guided self-help worksheets for parents of emotional and behavioral problems of children.
The quantitative phase will be an RCT involving approximately 108 students and parents (in each arm) to assess the effectiveness of "Play Therapy" for students having emotional and behavioral problems and "Mindful parenting" for parents of these children having emotional and behavioral problems. All those who fulfill the diagnostic criteria of emotional and behavioral problems and are studying in schools will be included in the study.
The intervention group of the RCT will receive Play Therapy and mindful parenting intervention in addition to the treatment as usual (TAU) while the control group receives TAU. The assessment will be carried out at baseline and at the end of therapy (8 weeks). Strength and difficulty Questionnaire (SDQ) with children, and Bangor mindful parenting scale, emotional regulation scale, parenting styles, and marital satisfaction scale with parents will be used respectively. Schwartz Outcome Scale will be used at the follow-up to measure the outcome.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Khyber Pakhtunkhaw
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Peshawar, Khyber Pakhtunkhaw, Pakistan, 25000
- Prime Foundation/Private Schools
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
For the quantitative part of the study:
- children having emotional and behavioral problems in the age range of 10 to 13 years
- Parents of these children with at least 10 years of educational level.
Exclusion Criteria:
- Children having epilepsy
- cerebral palsy
- learning disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Play Therapy
Play therapy will be given to the participants.
|
Play therapy will be given to children having emotional and behavioral problems.
|
Experimental: Group 2: Mindful Parenting
Mindful parenting worksheets will be given to the parents.
|
Culturally adapted mindful parenting worksheets will be given to the parents of children having emotional and behavioral problems.
|
Experimental: Group 3: (Combined Interventions of both Group 1 & 2)
Play therapy will be given to children and in addition, culturally adapted mindful parenting worksheets will be given to the parents of children having emotional and behavioral problems.
|
Play therapy will be given to children and in addition, culturally adapted mindful parenting worksheets will be given to the parents of children having emotional and behavioral problems.
|
No Intervention: Group 4: Treatment as usual
No intervention will be given to the participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength and Difficulty Questionnaire
Time Frame: 8 weeks (2 months)
|
Change in the score of the Strength and difficulty questionnaire (SDQ) from baseline to end of therapy.
Minimum Score = 0 Maximum Score = 40.
Normal score 0-15, Borderline score 16-19, Abnormal score 20-40.
Higher scores mean a worse outcome.
|
8 weeks (2 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Bangor Mindful Parenting Scale
Time Frame: 8 weeks (2 months)
|
Change in the score of The Bangor Mindful Parenting Scale from baseline to end of therapy.
Higher scores mean a worse outcome.
|
8 weeks (2 months)
|
Emotion Regulations Questionnaire
Time Frame: 8 weeks (2 months)
|
Change in the score of Emotion Regulations Questionnaire from baseline to end of therapy.
The greater the use of emotional regulation strategies, the higher the score will be.
Higher scores mean a worse outcome.
|
8 weeks (2 months)
|
Parenting Style Questionnaire
Time Frame: 8 weeks (2 months)
|
Change in the score of the Parenting style questionnaire from baseline to end of therapy.
Higher scores mean a worse outcome.
|
8 weeks (2 months)
|
Kansas Marital Satisfaction Scale
Time Frame: 8 weeks (2 months)
|
Change in the score of the Kansas marital satisfaction scale from baseline to end of therapy.
The higher scores mean better marital quality
|
8 weeks (2 months)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mifrah R Sethi, MSc, MPhil, Peshawar Medical College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mindfulness & Play Therapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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