NCT03271346

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

September 5, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

February 17, 2015

Last Update Submit

August 31, 2017

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in CROPS following treatment

    Child (self-) Report of Posttraumatic Symptoms

    Pre-treatment, 2 weeks post-treatment, 2 months post-treatment

  • Change in PROPS following treatment

    Parent Report of Posttraumatic Symptoms

    Pre-treatment, 2 weeks post-treatment, 2 months post-treatment

  • Change in SUDS following treatment

    Subjective Units of Distress Scale

    Pre-treatment, 2 weeks post-treatment, 2 months post-treatment

  • Change in PRS following treatment

    Problem Rating Scale

    Pre-treatment, 2 weeks post-treatment, 2 months post-treatment

Interventions

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children exposed to parental conflict and contested custody

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trauma Institute & Child Trauma Institute

Northampton, Massachusetts, 01060, United States

RECRUITING

MeSH Terms

Conditions

Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Ricky Greenwald, PsyD

    Trauma Institute & Child Trauma Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricky Greenwald, PsyD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

September 5, 2017

Study Start

February 1, 2015

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

September 5, 2017

Record last verified: 2017-08

Locations