search
Back to results

Cognitive Behavior Play Therapy and Culturally Adapted Mindfulness-Based Guided Self-Help for Parents

Primary Purpose

Emotional Problem, Behavior Problem

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group 1: Play Therapy
Group 2: Mindful Parenting
Group 3: (Combined Interventions of both Group 1 & 2)
Sponsored by
Muhammad Irfan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotional Problem focused on measuring Play therapy, Mindful parenting, Emotional Problems, Behavioral Problems

Eligibility Criteria

10 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For the quantitative part of the study:

  1. children having emotional and behavioral problems in the age range of 10 to 13 years
  2. Parents of these children with at least 10 years of educational level.

Exclusion Criteria:

  1. Children having epilepsy
  2. cerebral palsy
  3. learning disability

Sites / Locations

  • Prime Foundation/Private Schools

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Group 1: Play Therapy

Group 2: Mindful Parenting

Group 3: (Combined Interventions of both Group 1 & 2)

Group 4: Treatment as usual

Arm Description

Play therapy will be given to the participants.

Mindful parenting worksheets will be given to the parents.

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 will be given to the participants

Outcomes

Primary Outcome Measures

Strength and Difficulty Questionnaire
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.

Secondary Outcome Measures

The Bangor Mindful Parenting Scale
Change in the score of The Bangor Mindful Parenting Scale from baseline to end of therapy. Higher scores mean a worse outcome.
Emotion Regulations Questionnaire
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.
Parenting Style Questionnaire
Change in the score of the Parenting style questionnaire from baseline to end of therapy. Higher scores mean a worse outcome.
Kansas Marital Satisfaction Scale
Change in the score of the Kansas marital satisfaction scale from baseline to end of therapy. The higher scores mean better marital quality

Full Information

First Posted
October 5, 2022
Last Updated
October 2, 2023
Sponsor
Muhammad Irfan
Collaborators
University of Peshawar
search

1. Study Identification

Unique Protocol Identification Number
NCT05574569
Brief Title
Cognitive Behavior Play Therapy and Culturally Adapted Mindfulness-Based Guided Self-Help for Parents
Official Title
Effect of Cognitive Behavior Play Therapy and Culturally Adapted Mindfulness-Based Guided Self-Help for Parents of Children With Emotional and Behavioral Problems
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Muhammad Irfan
Collaborators
University of Peshawar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Emotional and behavioral problems not only affect the Child's life but also have long-lasting effects on families and society and few studies have been carried out to assess these problems. During the critical phase of childhood, a child may face many emotional and social pressures that can develop physical, behavioral, social, and academic problems, negatively impacting on child's school performance, social involvement, self-esteem along with other serious mental health issues. There is a relationship between traditional parenting practices (such as parental control, love, and rejection) and emotional problems of children including depression and anxiety but very little is known about the role of mindful parenting. Globally, many studies have been done on the prevalence of emotional and behavioral problems in children, whereas relatively little is known about the prevalence of child mental health problems and related risk factors in Pakistan. One of the treatments that they are using these days to provide the developmentally appropriate and therefore effective intervention that meets the mental health needs of children is Cognitive Behavior Play Therapy and mindful parenting.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Problem, Behavior Problem
Keywords
Play therapy, Mindful parenting, Emotional Problems, Behavioral Problems

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Play Therapy
Arm Type
Experimental
Arm Description
Play therapy will be given to the participants.
Arm Title
Group 2: Mindful Parenting
Arm Type
Experimental
Arm Description
Mindful parenting worksheets will be given to the parents.
Arm Title
Group 3: (Combined Interventions of both Group 1 & 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 4: Treatment as usual
Arm Type
No Intervention
Arm Description
No intervention will be given to the participants
Intervention Type
Behavioral
Intervention Name(s)
Group 1: Play Therapy
Intervention Description
Play therapy will be given to children having emotional and behavioral problems.
Intervention Type
Behavioral
Intervention Name(s)
Group 2: Mindful Parenting
Intervention Description
Culturally adapted mindful parenting worksheets will be given to the parents of children having emotional and behavioral problems.
Intervention Type
Behavioral
Intervention Name(s)
Group 3: (Combined Interventions of both Group 1 & 2)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Strength and Difficulty Questionnaire
Description
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.
Time Frame
8 weeks (2 months)
Secondary Outcome Measure Information:
Title
The Bangor Mindful Parenting Scale
Description
Change in the score of The Bangor Mindful Parenting Scale from baseline to end of therapy. Higher scores mean a worse outcome.
Time Frame
8 weeks (2 months)
Title
Emotion Regulations Questionnaire
Description
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.
Time Frame
8 weeks (2 months)
Title
Parenting Style Questionnaire
Description
Change in the score of the Parenting style questionnaire from baseline to end of therapy. Higher scores mean a worse outcome.
Time Frame
8 weeks (2 months)
Title
Kansas Marital Satisfaction Scale
Description
Change in the score of the Kansas marital satisfaction scale from baseline to end of therapy. The higher scores mean better marital quality
Time Frame
8 weeks (2 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mifrah R Sethi, MSc, MPhil
Organizational Affiliation
Peshawar Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prime Foundation/Private Schools
City
Peshawar
State/Province
Khyber Pakhtunkhaw
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Behavior Play Therapy and Culturally Adapted Mindfulness-Based Guided Self-Help for Parents

We'll reach out to this number within 24 hrs