Clinical trial NCT05574569: 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
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Problem
Behavior Problem
Keywords: Play therapy
Mindful parenting
Emotional Problems
Behavioral Problems
Lead sponsor: Peshawar Medical College
Sponsor class: OTHER
Collaborators: name: University of Peshawar
First posted: 2022-10-10
Enrollment: 432
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Strength and Difficulty Questionnaire
timeFrame: 8 weeks (2 months)
Secondary outcomes:
measure: The Bangor Mindful Parenting Scale
timeFrame: 8 weeks (2 months)
measure: Emotion Regulations Questionnaire
timeFrame: 8 weeks (2 months)
measure: Parenting Style Questionnaire
timeFrame: 8 weeks (2 months)
measure: Kansas Marital Satisfaction Scale
timeFrame: 8 weeks (2 months)
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Prime Foundation/Private Schools
state: Khyber Pakhtunkhaw
Study officials:
affiliation: Peshawar Medical College
name: Mifrah R Sethi, MSc, MPhil
role: PRINCIPAL_INVESTIGATOR
References: