CompletedNot Applicable

Therapeutic Play and Its Effect on Children's Psychosocial Well-Being

Turkey (Türkiye)53 participantsStarted 2024-05-01

Plain-language summary

The aim of this study was to evaluate the effectiveness of the Therapeutic Play-Based Intervention Programme (TOTEM), which was developed to reduce the negative psychosocial effects of the earthquake in children aged 4-6 years, and its effect on children's psychosocial well-being.

Who can participate

Age range

4 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Being between the ages of 4-6 * Having literate parents * Having adequate Turkish receptive-expressive language skills * Not having a previously diagnosed psychiatric problem declared by the parents * Not having participated in a training programme on psychosocial well-being before * Not attending any pre-school education institution at the time of the training * Volunteering to participate in the study by themselves and their parents Exclusion Criteria: * The participant wants to leave the study * The participant has not participated in one or more of the trainings to be given within the scope of the programme * The participant shows any diagnosed atypical development * Children who show a level of resistance that disrupts their adaptation to normal life in pre-tests, during the study or in post-tests, children with anxiety disorder or other psychiatric problems

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anxiety Scale in Preschool Children

Timeframe: A total of 3 evaluations will be made: before the programme starts, the post-test immediately after the end of the programme and the retention test at the end of the first month.

Psychosocial Status Assessment Scale for 3-6 Year Old Children (Parent Form)

Timeframe: A total of 3 evaluations will be made: before the programme starts, the post-test immediately after the end of the programme and the retention test at the end of the first month.

Sleep Disturbance Scale for Children

Timeframe: A total of 3 evaluations will be made: before the programme starts, the post-test immediately after the end of the programme and the retention test at the end of the first month.

Trial details

NCT IDNCT06845111

SponsorKocaeli University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Therapeutic Play trials

Who can participate

Age range

4 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Anxiety Scale in Preschool Children

Timeframe: A total of 3 evaluations will be made: before the programme starts, the post-test immediately after the end of the programme and the retention test at the end of the first month.

Psychosocial Status Assessment Scale for 3-6 Year Old Children (Parent Form)

Timeframe: A total of 3 evaluations will be made: before the programme starts, the post-test immediately after the end of the programme and the retention test at the end of the first month.

Sleep Disturbance Scale for Children

Timeframe: A total of 3 evaluations will be made: before the programme starts, the post-test immediately after the end of the programme and the retention test at the end of the first month.