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

NCT ID: NCT05574569

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Emotional Problem Behavior Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1: Play Therapy

Play therapy will be given to the participants.

Group Type EXPERIMENTAL

Group 1: Play Therapy

Intervention Type BEHAVIORAL

Play therapy will be given to children having emotional and behavioral problems.

Group 2: Mindful Parenting

Mindful parenting worksheets will be given to the parents.

Group Type EXPERIMENTAL

Group 2: Mindful Parenting

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

Group 4: Treatment as usual

No intervention will be given to the participants

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Group 1: Play Therapy

Play therapy will be given to children having emotional and behavioral problems.

Intervention Type BEHAVIORAL

Group 2: Mindful Parenting

Culturally adapted mindful parenting worksheets will be given to the parents of children having emotional and behavioral problems.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Peshawar

OTHER

Sponsor Role collaborator

Muhammad Irfan

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Irfan

Professor & Head, Department of Mental Health, Psychiatry and Behavioural Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mifrah R Sethi, MSc, MPhil

Role: PRINCIPAL_INVESTIGATOR

Peshawar Medical College

Locations

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Prime Foundation/Private Schools

Peshawar, Khyber Pakhtunkhaw, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Mindfulness & Play Therapy

Identifier Type: -

Identifier Source: org_study_id

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