Protocol summary

Summary
Aim: to examin the effect of attachment based play therapy on developmental traumatic disorder (DTD). Materials and Methods: Fourteen patients, who were diagnosed by a child psychiatrist as having DTD based on Vander Kolk criteria, were selected from child psychiatry clinic in Ibn-e-Sina and Sheikh hospitals, Mashhad, Iran. Patients were divided to 2 groups of intervention and control. Mothers of children completed Yule’s PTSD scale and parenting stress Index- short form (PSI-SF). Ten sessions of developmental play therapy were conducted for intervention groups. Mothers of children in 2 groups completed the tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207035280N8
Registration date: 2012-09-25, 1391/07/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-25, 1391/07/04
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2010-03-16, 1388/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of developmental attachment-based play therapy on developmental trauma disorder symptoms in children from 3 to 9 years old
Public title
The efficacy of developmental attachment-based play therapy on developmental trauma disorder symptoms in children from 3 to 9 years old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of developmental trauma disorder based on Vander Kolk criteria; mothers of children completed permission form. Exclusion criteria: : medical disorders; taking drug.
Age
From 3 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 14
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Daneshgah Street, Ghoreish building
City
Mashhad
Postal code
Approval date
2010-07-25, 1389/05/03
Ethics committee reference number
87451

Health conditions studied

1

Description of health condition studied
developmental trauma disorder symptoms
ICD-10 code
F93.8
ICD-10 code description
Other childhood emotional disorders

Primary outcomes

1

Description
post traumatic stress disorder
Timepoint
before & after intervention
Method of measurement
Yule’s PTSD scale and parenting stress Index- short form (PSI-SF)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group take part in 10 play therapy sessions.
Category
Behavior

2

Description
Controls are on the waiting list for treatment. Also free play therapy sessions with supportive approach are conducted for controls to the end of study, then controls are removed from waiting list and treatment is begun for them based on families' desire.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Children clinic in Ebn-e-Sina hospital
Full name of responsible person
Street address
City
Mashhad

2

Recruitment center
Name of recruitment center
Children clinic of dr Sheikh hospital
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ardakanian Marjan
Street address
Ghoreish building, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Rezaei Ardani
Position
Assistant professor
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
razaeaia@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atefeh Soltanifar
Position
Assistant professor
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
soltanifara@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Rezaei Ardani
Position
Assistant professor
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital
City
Mashhad
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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