Conflict, InterparentalNCT03271346
Intensive Trauma Treatment for Children Exposed to Parental Conflict
An observational study of Conflict, Interparental and Trauma, Psychological, run by Trauma Institute & Child Trauma Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Conflict, Interparental, Trauma, Psychological
- What is being tested?
- intensive trauma-focused therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 30 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children exposed to parental conflict and contested custody
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Trauma Institute & Child Trauma Institute
Northampton, Massachusetts, 01060
Ricky Greenwald, PsyD, 413-774-2340, cti@childtrauma.com
About this study
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.
- Conditions
- Conflict, Interparental, Trauma, Psychological
- Being tested
- intensive trauma-focused therapy
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive trauma-focused therapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CROPS following treatment
Child (self-) Report of Posttraumatic Symptoms
Measured: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Change in PROPS following treatment
Parent Report of Posttraumatic Symptoms
Measured: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Change in SUDS following treatment
Subjective Units of Distress Scale
Measured: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Change in PRS following treatment
Problem Rating Scale
Measured: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study startFeb 2015
- Primary completion30 Jan 2019 (estimated)
- Study completion30 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conflict, InterparentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trauma Institute & Child Trauma Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Gratis Foundation
- Responsible party
- Sponsor
- Investigators
- Ricky Greenwald, PsyD, Principal investigator, Trauma Institute & Child Trauma Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271346
- Sponsor's protocol ID
- 2015-GRE-1
- Status last verified
- Aug 2017
- First submitted
- 17 Feb 2015
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Trauma Treatment for Children Exposed to Parental Conflict
- ClinicalTrials.gov ID
- NCT03271346
- Acronym / sponsor ID
- 2015-GRE-1
- Conditions
- Conflict, Interparental, Trauma, Psychological
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Trauma Institute & Child Trauma InstituteUniversity, hospital or other
- Collaborators
- Gratis Foundation
- Study start
- Feb 2015
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children exposed to parental conflict and contested custody
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive trauma-focused therapy | Behavioural | – |
Primary outcome
Change in CROPS following treatment
Time frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Child (self-) Report of Posttraumatic Symptoms
Change in PROPS following treatment
Time frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Parent Report of Posttraumatic Symptoms
Change in SUDS following treatment
Time frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Subjective Units of Distress Scale
Change in PRS following treatment
Time frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
Problem Rating Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
Related trials for Conflict, Interparental
Recruiting
Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation
Mental Health, Parenting / Maternal Behavior
Recruiting
Pilot Study of an Interparental Conflict Intervention for Separating or Divorcing Parents
Interparental Conflict, Child Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricky Greenwald, PsyD principal investigator
Trauma Institute & Child Trauma Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conflict, Interparental and Trauma, Psychological, run by Trauma Institute & Child Trauma Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricky Greenwald, PsyD (413-774-2340, cti@childtrauma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CROPS following treatment (time frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.