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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03271346
Other study ID # 2015-GRE-1
Secondary ID
Status Recruiting
Phase N/A
First received February 17, 2015
Last updated August 31, 2017
Start date February 2015
Est. completion date January 30, 2019

Study information

Verified date August 2017
Source Trauma Institute & Child Trauma Institute
Contact Ricky Greenwald, PsyD
Phone 413-774-2340
Email cti@childtrauma.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to track outcomes of the investigator's therapy approach with children of separation/divorce who have been exposed to parental conflict.


Recruitment information / eligibility

Status Recruiting
Enrollment 4
Est. completion date January 30, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria:

- child between the ages of 6 - 16

- parent concerned re child's distress and behaviors related to custody, visitation, etc.

- parent has the legal authority to obtain treatment for the child

- parent and child fluent in English

Exclusion Criteria:

- as per clinical judgment of the PI during a telephone screening (interview of the referring parent), determination that the child is unlikely to be responsive to the intensive therapy format. This would typically be due to the child having a severe intellectual impairment, major dissociative disorder, etc.

Study Design


Intervention

Behavioral:
intensive trauma-focused therapy


Locations

Country Name City State
United States Trauma Institute & Child Trauma Institute Northampton Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Trauma Institute & Child Trauma Institute Gratis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in CROPS following treatment Child (self-) Report of Posttraumatic Symptoms Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Primary Change in PROPS following treatment Parent Report of Posttraumatic Symptoms Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Primary Change in SUDS following treatment Subjective Units of Distress Scale Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Primary Change in PRS following treatment Problem Rating Scale Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
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