NCT05574569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 5, 2022

Last Update Submit

October 2, 2023

Conditions

Emotional ProblemBehavior Problem

Keywords

Play therapyMindful parentingEmotional ProblemsBehavioral Problems

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The Bangor Mindful Parenting Scale

    8 weeks (2 months)

  • Emotion Regulations Questionnaire

    8 weeks (2 months)

  • Parenting Style Questionnaire

    8 weeks (2 months)

  • Kansas Marital Satisfaction Scale

    8 weeks (2 months)

Study Arms (4)

Group 1: Play Therapy

EXPERIMENTAL

Play therapy will be given to the participants.

Behavioral: Group 1: Play Therapy

Group 2: Mindful Parenting

EXPERIMENTAL

Mindful parenting worksheets will be given to the parents.

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.

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

Interventions

Group 1: Play TherapyBEHAVIORAL

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

Group 1: Play Therapy
Group 2: Mindful ParentingBEHAVIORAL

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

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

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children having epilepsy
  • cerebral palsy
  • learning disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prime Foundation/Private Schools

Peshawar, Khyber Pakhtunkhaw, 25000, Pakistan

Location

MeSH Terms

Conditions

Mental DisordersProblem Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild Behavior

Study Officials

  • Mifrah R Sethi, MSc, MPhil

    Peshawar Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor & Head, Department of Mental Health, Psychiatry and Behavioural Sciences

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 10, 2022

Study Start

March 1, 2022

Primary Completion

December 31, 2022

Study Completion

July 31, 2023

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)