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

Behavior Problem Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05574569
• Other study ID #: Mindfulness & Play Therapy
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2023
• Source: Peshawar Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: July 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior Problem
• Emotional Problem
• Problem Behavior

Intervention

Behavioral:
• Group 1: Play Therapy
Play therapy will be given to children having emotional and behavioral problems.
• Group 2: Mindful Parenting
Culturally adapted mindful parenting worksheets will be given to the parents of children having emotional and behavioral problems.
• 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.

Locations

Country	Name	City	State
Pakistan	Prime Foundation/Private Schools	Peshawar	Khyber Pakhtunkhaw

Sponsors (2)

Lead Sponsor	Collaborator
Muhammad Irfan	University of Peshawar

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks (2 months)
Secondary	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.	8 weeks (2 months)
Secondary	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.	8 weeks (2 months)
Secondary	Parenting Style Questionnaire	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)
Secondary	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	8 weeks (2 months)