- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07401030
Effectiveness of a Psychological Resilience Training Program for Children Aged 10-12
The Effectiveness of a Psychological Resilience Training Program for Children Aged 10-12: An Evaluation in Terms of Psychological Resilience, Social Adjustment, Close Relationships, and Media Use
This clinical study aims to learn whether a psychological resilience training program is helpful for children aged 10 to 12 years. The program is designed to help children cope better with stress, get along better with others, and use digital media in a healthier way.
The main questions this study seeks to answer are:
Does the training increase children's psychological resilience?
Does it improve children's social adjustment and close relationships with family and friends?
Does it help reduce problematic media use?
Children who take part in the study are randomly assigned to one of two groups. One group takes part in a psychological resilience training program, and the other group does not receive any training during the study period. Children and their parents complete questionnaires before the program and again after the program is completed.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is planned as a randomized controlled interventional trial to evaluate the effects of a structured psychological resilience training program on multiple psychosocial outcomes in children aged 10-12 years. The study will be conducted in a school setting in Agri, Turkey.
A total of 50 eligible children who meet the inclusion criteria will be enrolled in the study. After completion of baseline assessments, participants will be randomly assigned to an intervention group (n = 25) or a control group (n = 25) using a simple randomization method. Group allocation will be coded to reduce potential bias during data analysis. Participants and their parents will not be informed about group assignment, and statistical analyses will be performed by an independent analyst who will be blinded to group codes.
The intervention group will receive a school-based psychological resilience training program developed for children and adolescents. The program will be delivered in a group format and will consist of 10 sessions implemented over a five-week period, with two sessions per week. The session content will include emotional awareness and regulation, self-awareness and identification of personal strengths, self-efficacy, coping with stressful situations, problem-solving skills, cognitive flexibility, social skills development, communication skills, utilization of social support resources, and media use awareness and self-control. The control group will not receive any intervention during the study period and will participate only in assessment procedures.
Data will be collected at two time points: at baseline (prior to randomization) and at follow-up after completion of the intervention period. Child-reported and parent-reported standardized measures will be used to assess psychological resilience, social adjustment, problematic media use, and parent-child relationship characteristics. The study will be conducted in accordance with ethical principles and will be approved by a university ethics committee prior to participant enrolment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: YUSUF AKTEPE, MSc / Graduate Student
- Phone Number: +905439436504
- Email: aktepe.yusuf.aktepe@gmail.com
Study Locations
-
-
Ağrı
-
Ağrı, Ağrı, Turkey (Türkiye), 25080
- Alpaslan Middle School
-
Contact:
- YUSUF AKTEPE, MSc / Graduate Student / RN
- Phone Number: +905439436504
- Email: aktepe.yusuf.akteğe@gmail.com
-
Principal Investigator:
- YUSUF AKTEPE, MSc / RN / Graduate Student
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 10 to 12 years
- Enrollment in a primary or middle school
- Ability to understand and participate in group-based educational activities
- Willingness of the child to participate in the study
- Written informed consent provided by a parent or legal guardian
- No prior participation in a psychological resilience or emotional regulation training program
Exclusion Criteria:
- Presence of a diagnosed severe psychiatric disorder (e.g., psychotic disorders or severe behavioral disorders)
- Cognitive impairment that would prevent understanding the training content or completing assessments
- Participation in another psychological or behavioral intervention during the study period
- Absence from a substantial portion of the intervention sessions
- Withdrawal of consent by the child or parent/legal guardian at any stage of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychological resilience training program
Participants in this arm will receive a structured psychological resilience training program designed for children aged 10-12 years.
The program will be delivered in a group format and will consist of 10 sessions over a five-week period.
The sessions will focus on emotion recognition and regulation, self-awareness, self-efficacy, coping with stress, problem-solving skills, social skills, social support, and media use awareness.
|
This is a structured, school-based psychological resilience training program designed for children aged 10-12 years.
The program consists of 10 group sessions delivered over a five-week period (two sessions per week).
Session content includes emotion recognition and regulation, self-awareness and identification of personal strengths, self-efficacy, coping with stressful situations, problem-solving skills, cognitive flexibility, social skills development, communication skills, social support utilization, and media use awareness and self-control.
|
|
No Intervention: No-intervention control
Participants in this arm will not receive any psychological or educational intervention during the study period.
They will continue with their usual school activities and will complete the same assessments as the intervention group at the scheduled time points.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PSYCHOLOGICAL RESILIENCE
Time Frame: Time Frame: Baseline (before the intervention) and follow-up (one month after completion of the training program)
|
Psychological resilience will be measured using the Children and Youth Resilience Measure-12 (CYRM-12).
This scale assesses children's ability to cope with stress and challenging life situations.
Total scores range from 12 to 60, with higher scores indicating greater psychological resilience.
|
Time Frame: Baseline (before the intervention) and follow-up (one month after completion of the training program)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SOCIAL ADJUSTMENT
Time Frame: Time Frame: Baseline (before the intervention) and follow-up (one month after completion of the training program)
|
Social adjustment will be measured using the Social Adjustment Scale (SUÖ).
This scale assesses children's ability to adapt to social rules, interact effectively with peers, and function appropriately in social settings.
Total scores range from 55 to 275, with higher scores indicating better social adjustment.
|
Time Frame: Baseline (before the intervention) and follow-up (one month after completion of the training program)
|
|
PROBLEMATIC MEDIA USE
Time Frame: Time Frame: Baseline (before the intervention) and follow-up (one month after completion of the training program)
|
Problematic media use will be assessed using the Problematic Media Use Scale (PMKÖ), a parent-reported measure that evaluates children's difficulties in controlling and regulating digital media and screen use.
Scores are calculated on a Likert-type scale ranging from 1 to 5, with higher scores indicating more problematic media use.
|
Time Frame: Baseline (before the intervention) and follow-up (one month after completion of the training program)
|
|
PARENT-CHILD RELATIONSHIP
Time Frame: Time Frame: Baseline (before the intervention) and follow-up (one month after completion of the training program)
|
Parent-child relationship will be assessed using the Parent-Child Relationship Scale (EÇİÖ), a parent-reported instrument consisting of 15 items that assess both positive and negative dimensions of the parent-child relationship.
Items are rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely).
Higher scores on the positive subscale indicate more positive relationship characteristics, whereas higher scores on the negative subscale indicate more negative relationship characteristics.
|
Time Frame: Baseline (before the intervention) and follow-up (one month after completion of the training program)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yusuf AKTEPE, MSc / RN / Graduate Student, Agri Ibrahim Cecen University
Publications and helpful links
General Publications
- Masten AS. Resilience in children threatened by extreme adversity: Frameworks for research, practice, and translational synergy. Development and Psychopathology. 2011;23(2):493-506.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AICU-SBF-YA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychological Resilience
-
National University of SingaporeCompletedResilience, PsychologicalSingapore
-
Consorci Sanitari de TerrassaDepartment of Health, Generalitat de CatalunyaCompleted
-
National University of SingaporeCompletedAdaptation, Psychological | Resilience, PsychologicalHong Kong
-
Xiaoxuan LiuNot yet recruiting
-
Babes-Bolyai UniversityRomanian National Authority for Scientific ResearchCompleted
-
Gazi UniversityCompleted
-
Catholic University of Applied Sciences MainzRecruitingResilience, Psychological | Personnel, HospitalGermany
-
İstanbul Yeni Yüzyıl ÜniversitesiNot yet recruitingWell-being | Psychological Resilience
-
Central South UniversityTerminatedHappiness | Bereavement | Resilience,PsychologicalChina
-
Nermin UyurdağCompletedPsychological Resilience | Nursing | Disaster ManagementTurkey (Türkiye)
Clinical Trials on Psychological Resilience Training Program
-
Eskisehir Osmangazi UniversityNot yet recruitingPediatric Cancer | Resilience, Psychological | Mobile Application | Coping | Adolescent Cancer | Pediatric NursingTurkey (Türkiye)
-
Eastern Mediterranean UniversityNot yet recruiting
-
Ain Shams UniversityRecruitingPerceived StressEgypt
-
University of OttawaCompleted
-
AdventHealthJohnson & JohnsonCompleted
-
Ege UniversityCompletedPsychological Resilience | Psychological Well-beingTurkey (Türkiye)
-
Mayo ClinicTerminatedStress | Inflammatory Bowel DiseasesUnited States
-
Stony Brook UniversityNorthwell Health; Department of Health and Human Services; Rutgers UniversityCompleted
-
Dalhousie UniversityUnknownMindfulness | Students | Adverse Childhood ExperiencesCanada