NCT06984198

Brief Summary

Due to the political state of Syria, Jordan is experiencing a major increase in the number of Syrians seeking asylum each year, a quarter of which are children. The stressors these refugees are exposed to are described in three stages: (1) while in their country of origin; (2) during their escape to safety; and (3) when having to settle in a country of refuge. The available literature shows consistently increased levels of psychological morbidity among refugee children, especially post-traumatic stress disorder (PTSD). It is argued that mental health clinics could use creative art therapies as a means of reaching out to war refugees in their communities who may not respond to traditional therapy. The difference in effectiveness between art and sand-play therapy, two models of nonverbal psychosocial therapy, on Syrian refugee children with PTSD, will be evaluated using a pretest-posttest control group design with 90 preadolescents (ages 6-12) exhibiting PTSD. Children will be randomized into two experimental groups (n = 30 for each) to receive sandplay or art therapy for 12 weeks, while the control group (n = 30) will receive no formal treatment. The effectiveness of each form of therapy will be determined using a questionnaire and then compared within and between group(s). Further statistical analysis will be used to determine which therapy was more effective in mitigating PTSD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

2.1 years

First QC Date

April 26, 2025

Last Update Submit

May 19, 2025

Conditions

Keywords

Syrian refugeePTSDSandplayart therapymental healthRandomized trialChildren

Outcome Measures

Primary Outcomes (1)

  • HTQ

    HTQ: Harvard Trauma Questionnaire, translated into Arabic. Harvard Trauma Questionnaire (HTQ) checklist will be used to assess the mental health status of children in a pre and post intervention format. The checklist, written by Harvard Program in Refugee Trauma (HPRT), inquires about a variety of trauma events, as well as the emotional symptoms considered to be uniquely associated with trauma (Harvard Trauma Questionnaire, 2011). The scoring method used in this study will be adapted from this questionnaire and will include questions to help determine the children's PTSD severity, which will be split into three degrees: mild, moderate, and severe. The questionnaire used (please refer to Appendix B for a detailed outline of the instrument) comprises of 16 questions, each with a rating of 1-4 (1: not at all and 4: extremely). Subjects with scores between 16-32, 33-48, or 49-64 were considered mild, moderate, or severe, respectively. HTQ checklist will be translated into Arabic.

    Week 1, pre-intervention, and then week 14, post-intervention.

Study Arms (3)

Sandplay therapy

EXPERIMENTAL

Sandplay Therapy - The objects involved in this form of therapy are: sandtray, sand, multiple figurines in all categories (people, animals, buildings, vehicles, vegetation, structures, natural objects and symbolic objects). The subject engaging in this therapy is instructed to build a sand picture with the minatures present. There is no time limit to these sessions; however, they tend to be 20-30 minutes long. Upon completion of their sand picture the child, if comfortable, may elaborate on their creation.

Behavioral: Sandplay Therapy

Art therapy

EXPERIMENTAL

Art Therapy - The instruments used in this form of therapy are: a blank 8" x 11" paper and coloring utensils (markers, crayons, and color pencils). During each 30-minute session, the subject is informed to draw whatever they feel with the coloring utensils provided. Possible drawing topics may include: their family, a memory of their life back in their country of origin, or something from their imagination.

Behavioral: Art Therapy

control

NO INTERVENTION

Standard care provided as per routine clinical practice.

Interventions

Sandplay Therapy - The objects involved in this form of therapy are: sandtray, sand, multiple figurines in all categories (people, animals, buildings, vehicles, vegetation, structures, natural objects and symbolic objects). The subject engaging in this therapy is instructed to build a sand picture with the minatures present. There is no time limit to these sessions; however, they tend to be 20-30 minutes long. Upon completion of their sand picture the child, if comfortable, may elaborate on their creation.

Sandplay therapy
Art TherapyBEHAVIORAL

Art Therapy - The instruments used in this form of therapy are: a blank 8" x 11" paper and coloring utensils (markers, crayons, and color pencils). During each 30-minute session, the subject is informed to draw whatever they feel with the coloring utensils provided. Possible drawing topics may include: their family, a memory of their life back in their country of origin, or something from their imagination.

Also known as: art drawing
Art therapy

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Syrian refugee children living in Jordan as a result of the war/conflict in Syria,
  • Ages between 6 and 12 years at the time of the study.
  • Reported to have experienced trauma related to the war/conflict in Syria (e.g. witnessed death, shrapnel injuries, and/or any forms of war violence) as diagnosed by the treating physician.
  • Lack of any pre-existing psychosocial issues.
  • Ability to secure parent or guardian consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zad Children Center

Amman, 26222, Jordan

Location

Related Publications (8)

  • Lee HJ, Na K, Kwon MS, Kim H, Kim KS, Paik YK. Quantitative analysis of phosphopeptides in search of the disease biomarker from the hepatocellular carcinoma specimen. Proteomics. 2009 Jun;9(12):3395-408. doi: 10.1002/pmic.200800943.

    PMID: 19562805BACKGROUND
  • Jones JM, Jolly RD. Dwarfism in Hereford cattle: a genetic morphological and biochemical study. N Z Vet J. 1982 Dec;30(12):185-9. doi: 10.1080/00480169.1982.34937.

    PMID: 16030843BACKGROUND
  • Garcia Vallejo R, Martinez Hernandez E, Amal Selfa R, Canada DA. [Working with the scientific method]. Rev Enferm. 2004 Jan;27(1):15-8. Spanish.

    PMID: 15040591BACKGROUND
  • Goggs R, Boag AK, Chan DL. Concurrent immune-mediated haemolytic anaemia and severe thrombocytopenia in 21 dogs. Vet Rec. 2008 Sep 13;163(11):323-7. doi: 10.1136/vr.163.11.323.

    PMID: 18791206BACKGROUND
  • Low N, Cowan F. Genital chlamydial infection. Clin Evid. 2002 Dec;(8):1601-7. No abstract available.

    PMID: 12603957BACKGROUND
  • Ng MH, Choo YM, Ma AN, Chuah CH, Hashim MA. Separation of vitamin E (tocopherol, tocotrienol, and tocomonoenol) in palm oil. Lipids. 2004 Oct;39(10):1031-5. doi: 10.1007/s11745-004-1327-y.

    PMID: 15691027BACKGROUND
  • Larsen FS. Is it worthwhile to use cerebral microdialysis in patients with acute liver failure? Neurocrit Care. 2006;5(3):173-5. doi: 10.1385/NCC:5:3:173. No abstract available.

    PMID: 17290083BACKGROUND
  • Carmichael, Karla Delle. "Sand Play as an Elementary School Strategy." Elementary School Guidance & Counseling, vol. 28, no. 4, 1994, pp. 302-07. JSTOR, http://www.jstor.org/stable/42871132.

    BACKGROUND

MeSH Terms

Conditions

Combat DisordersStress Disorders, Post-TraumaticPsychological Well-Being

Interventions

Play TherapyArt Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Abdallah Alzoubi, MD, PhD

    Medical School of Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR
  • Khalid A Kheirallah, PhD

    Medical School of Jordan University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Therapy Sessions In both the art and sand groups, each child will undergo 14 sessions, once per week. The first and last sessions will serve as pre and post-assessment sessions. The remainder 12 weeks will be the intervention period, where, depending on the child's randomized group assignment, they will either undergo no formal therapy (control), art, or sandplay therapy. SESSION 1: obtain the child's background history and consent, a pre-assessment of the child's condition using (HTQ). SESSION 2-13: Children in the sandplay and art therapy intervention groups will undergo their assigned therapies once a week. Session 14: HTQ, post intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology

Study Record Dates

First Submitted

April 26, 2025

First Posted

May 22, 2025

Study Start

April 1, 2015

Primary Completion

May 1, 2017

Study Completion

December 1, 2018

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

IPD were not actually collected as there was only age and sex of the participant along with their drawings that were needed as part of the data collection. This will be shared for reasonable use if needed as per the IRB requirements.

Shared Documents
STUDY PROTOCOL
Time Frame
Dec 2025

Locations