Intensive trauma-focused therapy in Trauma, Psychological and Conflict, Interparental - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Behavioral: intensive trauma-focused therapy

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 Locations

United States
- 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.

Sponsor

Trauma Institute & Child Trauma Institute

Collaborators

Gratis Foundation

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)