Emotional ProblemNCT05574569
Cognitive Behavior Play Therapy and Culturally Adapted Mindfulness-Based Guided Self-Help for Parents
A study testing Group 1: Play Therapy, Group 2: Mindful Parenting and Group 3: (Combined Interventions of both Group 1 & 2) in people with Emotional Problem and Behavior Problem, run by Muhammad Irfan at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Emotional Problem, Behavior Problem
- What is being tested?
- Group 1: Play Therapy, Group 2: Mindful Parenting and Group 3: (Combined Interventions of both Group 1 & 2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children having epilepsy
- cerebral palsy
- learning disability
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Prime Foundation/Private Schools
Peshawar, Khyber Pakhtunkhaw, 25000
About this study
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
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.
Read the 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.
- Conditions
- Emotional Problem, Behavior Problem
- Being tested
- Group 1: Play Therapy, Group 2: Mindful Parenting, Group 3: (Combined Interventions of both Group 1 & 2)
- Keywords
- Play therapy, Mindful parenting, Emotional Problems, Behavioral Problems
- Medical subject headings
- Mental Disorders, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Play TherapyBehavioural
Play therapy will be given to children having emotional and behavioral problems.
Group 2: Mindful ParentingBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Play Therapy | Experimental | Play therapy will be given to the participants. Receives: Behavioral: Group 1: Play Therapy |
| Group 2: Mindful Parenting | Experimental | Mindful parenting worksheets will be given to the parents. Receives: Behavioral: Group 2: Mindful Parenting |
| Group 3: (Combined Interventions of both Group 1 & 2) | Experimental | 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. Receives: Behavioral: Group 3: (Combined Interventions of both Group 1 & 2) |
| Group 4: Treatment as usual | No intervention | No intervention will be given to the participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks (2 months)
Secondary outcomes (4)
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.
Measured: 8 weeks (2 months)
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.
Measured: 8 weeks (2 months)
Parenting Style Questionnaire
Change in the score of the Parenting style questionnaire from baseline to end of therapy. Higher scores mean a worse outcome.
Measured: 8 weeks (2 months)
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
Measured: 8 weeks (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Irfan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Peshawar
- Responsible party
- Sponsor-investigator, Muhammad Irfan, Peshawar Medical College
- Investigators
- Mifrah R Sethi, MSc, MPhil, Principal investigator, Peshawar Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574569
- Sponsor's protocol ID
- Mindfulness & Play Therapy
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05574569
- Acronym / sponsor ID
- Mindfulness & Play Therapy
- Conditions
- Emotional Problem, Behavior Problem
- Keywords
- Play therapy, Mindful parenting, Emotional Problems, Behavioral Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Muhammad IrfanUniversity, hospital or other
- Collaborators
- University of Peshawar
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Play Therapy | Experimental | Behavioral: Group 1: Play TherapyPlay therapy will be given to the participants. |
| Group 2: Mindful Parenting | Experimental | Behavioral: Group 2: Mindful ParentingMindful parenting worksheets will be given to the parents. |
| Group 3: (Combined Interventions of both Group 1 & 2) | Experimental | 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. |
| Group 4: Treatment as usual | No intervention | –No intervention will be given to the participants |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Children having epilepsy
- cerebral palsy
- learning disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1: Play TherapyPlay therapy will be given to children having emotional and behavioral problems. | Behavioural | Group 1: Play Therapy |
| Group 2: Mindful ParentingCulturally adapted mindful parenting worksheets will be given to the parents of children having emotional and behavioral problems. | Behavioural | Group 2: Mindful Parenting |
| 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. | Behavioural | Group 3: (Combined Interventions of both Group 1 & 2) |
Primary outcome
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.
4 secondary outcomes
The Bangor Mindful Parenting Scale
Time frame: 8 weeks (2 months)
Emotion Regulations Questionnaire
Time frame: 8 weeks (2 months)
Parenting Style Questionnaire
Time frame: 8 weeks (2 months)
Kansas Marital Satisfaction Scale
Time frame: 8 weeks (2 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mifrah R Sethi, MSc, MPhil principal investigator
Peshawar Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: Play Therapy, Group 2: Mindful Parenting and Group 3: (Combined Interventions of both Group 1 & 2) in people with Emotional Problem and Behavior Problem, run by Muhammad Irfan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength and Difficulty Questionnaire (time frame: 8 weeks (2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.