NCT06845111

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Last Updated

November 21, 2025

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

February 20, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Childanxietypsychosocial statusdisturbancenursing care

Outcome Measures

Primary Outcomes (3)

  • Anxiety Scale in Preschool Children

    The Anxiety Scale in Preschool Children (Spence et al., 2001) developed by Spence, Rapee, McDonald, Ingram (2001) was adapted into Turkish by Şahin (2020). While the original scale had 28 items measuring social anxiety, separation anxiety, fear of physical injury, general anxiety and obsessive-compulsive disorder, Şahin added 5 items related to post-traumatic stress disorder while adapting it to Turkish and validity and reliability studies were conducted with these items. The scale is a 5-point scale and each item is scored between 0 and 4. A total score can be obtained from the scale. A high score on the scale indicates that anxiety in preschool children is high, while a low score indicates that anxiety in preschool children is low. Within the scope of the reliability of the scale, Cronbach's Alpha coefficient was calculated as 0.93 (Şahin, 2020). For this study, Cronbach's Alpha coefficient was calculated as 0.91.

    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)

    Psychosocial Situation Rating Scale (PSRS) was developed by Güneş-Şan and Altay and is a measurement tool consisting of 31 items that measures Psychosocial Situation Rating based on parental report in children aged 3-6 years. For each item in the PSDD, there are 5-point Likert type options 0-'never', 1-'rarely', 2-'sometimes', 3-"often", 4-'always'. Based on the score given for each item, a minimum score of '0' and a maximum score of '124' can be obtained from the questionnaire. A low total score indicates that there is no risk for psychosocial problems in the child, while a high score indicates that there is a risk for psychosocial problems. Within the scope of the reliability of the scale, Cronbach's Alpha coefficient was calculated as 0.83 and test-retest reliability was calculated as 0.957 (Güneş-Şan \& Altay, 2021). For this study, Cronbach's Alpha coefficient was calculated as 0.88.

    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

    The scale developed by Bruni et al. (1996) was adapted into Turkish and the validity and reliability study was conducted by Ağça-Bilmenoğlu (2019). The scale developed to investigate sleep disorders in children consists of 26 items and each question is scored between 1-5. The measurement tool includes questions measuring sleep initiation and maintenance problems, sleep breathing disorders, sleep-wake disorders, sleep-wake transition disorders, excessive sleepiness disorders and excessive sweating during sleep. The scores that can be obtained from the scale vary between 26 and 130, and high scores are interpreted as a high degree of sleep disorder. Within the scope of the reliability of the scale, Cronbach's Alpha coefficient was calculated as 0.84 and test-retest reliability as 0.79 (Ağça-Bilmenoğlu, 2019). For this study, Cronbach's Alpha coefficient was calculated as 0.85.

    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.

Study Arms (2)

Experimental: Group receiving Therapeutic Play

EXPERIMENTAL

The Therapeutic Play-Based Intervention Programme (TOTEM) designed for the research was carried out with the children in the intervention group on the determined days and hours. The children were administered the post-test immediately after the end of the programme and then the retention test at the end of the first month.

Other: Therapeutic play

Control Group

NO INTERVENTION

Control group (routine education programme): The children in the control group were administered a pre-test in the kindergartens they were currently attending (which were included in daily routine life, games, etc. by preschool teachers living in the city), a post-test after five weeks in parallel with the study group, and then a retention test at the end of the first month. Considering ethical principles, the TOTEM programme was also applied to the children in this group after the study was completed.

Interventions

In this context, the pre-school teachers in the container area were contacted and the sessions were held every Wednesday-Thursday (8 sessions in total) for 5 weeks, taking into account their availability hours. Children were included in the programme in groups of 12. Before data collection, the necessary materials were provided and stored in an empty container. It was found appropriate to complete the trainings in kindergartens located in the container city (4). A total of 3 evaluations were carried out: a post-test immediately after the end of the programme and a retention test at the end of the first month.

Experimental: Group receiving Therapeutic Play

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Izmit, 41001, Turkey (Türkiye)

Location

Related Publications (12)

  • Park EJ, Lee MS, Bae SM, Kim HS, Hong M, Kim E, Lee SK, Kim J, Bhang SY. Promising Effect of the Children in Disaster: Evaluation and Recovery Intervention on Trauma Symptoms and Quality of Life for Children and Adolescents: A Controlled Study. Psychiatry Investig. 2024 Feb;21(2):123-132. doi: 10.30773/pi.2023.0202. Epub 2024 Feb 8.

    PMID: 38321890BACKGROUND
  • Wong CL, Ip WY, Kwok BMC, Choi KC, Ng BKW, Chan CWH. Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial. BMJ Open. 2018 Jul 5;8(7):e021071. doi: 10.1136/bmjopen-2017-021071.

    PMID: 29980545BACKGROUND
  • Juwita, H. 2019. "Effectiveness of multimodal interventions play therapy: Colouring and origami against anxiety levels in toddler ages," Journal of Health Science and Prevention, 3(3S), 46-51.

    BACKGROUND
  • Silva, L., Oliveira, C., Oliveira, J., Bandeira, P., Matos, J., Gomes, E., et al. 2022. "Use of therapeutic play in nursing care for school-age children: a scoping review," Preprints (2022).

    BACKGROUND
  • Satapathy S, Dang S, Sagar R, Dwivedi SN. Resilience in Children and Adolescents Survived Psychologically Traumatic Life Events: A Critical Review of Application of Resilience Assessment Tools for Clinical Referral and Intervention. Trauma Violence Abuse. 2022 Jan;23(1):288-300. doi: 10.1177/1524838020939126. Epub 2020 Jul 23.

    PMID: 32700641BACKGROUND
  • Bratton, S., Ray, D., Rhine, T., & Jones, L. 2005. "The Efficacy of Play Therapy With Children: A Meta-Analytic Review of Treatment Outcomes," Professional Psychology: Research and Practice, 36, 376-390.

    BACKGROUND
  • Diaz-Rodriguez M, Alcantara-Rubio L, Aguilar-Garcia D, Perez-Munoz C, Carretero-Bravo J, Puertas-Cristobal E. The Effect of Play on Pain and Anxiety in Children in the Field of Nursing: A Systematic Review. J Pediatr Nurs. 2021 Nov-Dec;61:15-22. doi: 10.1016/j.pedn.2021.02.022. Epub 2021 Mar 10.

    PMID: 33711642BACKGROUND
  • Nursanaa, W., Ady, I. 2020. "Play Therapy for Children with Anxiety Disorders," Proceedings of Social Sciences & Humanities, 81-86.

    BACKGROUND
  • Gülmez, İ., & Karaaziz, M. 2023. "A systematic review on the use of play therapy in sexually abused children," The Journal of Social Sciences, 62(62), 450-466.

    BACKGROUND
  • Leblanc, M., & Ritchie, M. 2001. "A meta-analysis of play therapy outcomes," Counselling Psychology Quarterly, 14, 149-163.

    BACKGROUND
  • Humble JJ, Summers NL, Villarreal V, Styck KM, Sullivan JR, Hechler JM, Warren BS. Child-Centered Play Therapy for Youths Who Have Experienced Trauma: a Systematic Literature Review. J Child Adolesc Trauma. 2018 Nov 9;12(3):365-375. doi: 10.1007/s40653-018-0235-7. eCollection 2019 Sep.

    PMID: 32318206BACKGROUND
  • Ray, D. C., & Armstrong, S. A. 2021. "Child-centered play therapy: A review of research and practice," International Journal of Play Therapy, 30(1), 1-12.

    BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (third party blinding- Outcomes Assessor)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

May 1, 2024

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

November 21, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations