- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03271346
Intensive Trauma Treatment for Children Exposed to Parental Conflict
August 31, 2017 updated by: Trauma Institute & Child Trauma Institute
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karen Steward
- Phone Number: 413-774-2340
- Email: kjs@childtrauma.com
Study Locations
-
-
Massachusetts
-
Northampton, Massachusetts, United States, 01060
- Recruiting
- Trauma Institute & Child Trauma Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children exposed to parental conflict and contested custody
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in CROPS following treatment
Time Frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
|
Child (self-) Report of Posttraumatic Symptoms
|
Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
|
Change in PROPS following treatment
Time Frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
|
Parent Report of Posttraumatic Symptoms
|
Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
|
Change in SUDS following treatment
Time Frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
|
Subjective Units of Distress Scale
|
Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
|
Change in PRS following treatment
Time Frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
|
Problem Rating Scale
|
Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Anticipated)
January 30, 2019
Study Completion (Anticipated)
January 30, 2019
Study Registration Dates
First Submitted
February 17, 2015
First Submitted That Met QC Criteria
August 31, 2017
First Posted (Actual)
September 5, 2017
Study Record Updates
Last Update Posted (Actual)
September 5, 2017
Last Update Submitted That Met QC Criteria
August 31, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-GRE-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma, Psychological
-
Cantonal Hospital of St. GallenCompleted
-
Victor CarrionUniversity of South Carolina; Iowa State University; University of San Diego; Pure...CompletedStress, Psychological | Trauma, Psychological
-
Hôpital le VinatierNot yet recruitingTrauma, Psychological
-
Dominique JANUELRecruiting
-
University of OtagoRecruitingTrauma, Psychological | EarthquakeNew Zealand
-
Nottingham Trent UniversityNot yet recruitingTrauma, Psychological | Legal Education
-
Fondation LenvalRecruitingAnxiety Disorders | Stress, Psychological | Trauma, PsychologicalFrance
-
University of OtagoCanterbury Medical Research FoundationNot yet recruitingPsychological Distress | Trauma, Psychological | Emotional ProblemNew Zealand
-
University of SalfordCompletedTrauma, PsychologicalUnited Kingdom
-
Trauma Institute & Child Trauma InstituteUnknownTrauma, Psychological | Motor Vehicle AccidentUnited States
Clinical Trials on intensive trauma-focused therapy
-
Leiden UniversityRadboud University Medical Center; ZonMw: The Netherlands Organisation for... and other collaboratorsCompletedPost Traumatic Stress DisorderNetherlands
-
University of BaselUniversity of ZurichRecruitingMotivation | Alliance, TherapeuticSwitzerland
-
Stanford UniversityNational Institute of Mental Health (NIMH)CompletedAlcoholism | Sexually Transmitted Diseases, Viral | Sexual Behavior | Sexual Abuse | Child Abuse, SexualUnited States
-
Universität Duisburg-EssenCompleted
-
Medical University of South CarolinaNot yet recruitingPost-Traumatic Stress Disorder
-
Universidad Nacional Autonoma de MexicoCompletedPsychopathic Personality TraitMexico
-
Duke UniversityNational Institute of Mental Health (NIMH); University of Washington; Ace Africa and other collaboratorsCompletedDepressive Symptoms | Post Traumatic Stress Disorder | Behavioral Problems | Post Traumatic Stress | Childhood Traumatic Grief | Child Overall Daily Functioning | Child and Guardian RelationshipUnited States, Kenya, Tanzania
-
Delaware Division of Prevention and Behavioral...University of Delaware; University of Medicine and Dentistry of New JerseyUnknownPosttraumatic Stress DisorderUnited States
-
HAN University of Applied SciencesRecruitingTrauma | Psychological | Art TherapyNetherlands
-
Queen's University, BelfastWorld VisionCompletedPost-traumatic Stress Symptoms | Psychosocial DistressCongo