- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02181751
A 1-year Program to Treat Children Who Have Been Victims of Child Sexual Abuse
November 28, 2022 updated by: Little Warriors
Our goal in this study is examine if a program designed to decrease the severity of Post-Traumatic Stress Disorder symptoms in sexually abused children between the ages of 8-12 was effective.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Observational
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
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Alberta
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Ardrossan, Alberta, Canada
- Be Brave Ranch
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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
8 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- History of sexual abuse
- Aged 8 - 12 years
- Developmentally able to be on-site in a "camp-like" treatment facility for 3 weeks with their parent/guardian (or without if family is not available to join the child at the Be Brave Ranch)
- Able to perform skills of daily living for self care
- Good physical health
Exclusion Criteria:
- Severe mental health issues including (but not limited to):
- Recent suicide attempt
- History of psychosis
- History of significant self-harm
- History of homicidal thoughts or actions
- History of violent behaviours sufficient to be considered a threat to others
- Acute eating disorder.
- Significant risk of absconding, or history of absconding
- Serious behavioural problems
- Significant use of drugs or alcohol
- History of sexual violence or sexual behaviour towards others
- Any significant interaction with the justice system or police
- Cognitive impairment that would interfere with treatment benefits
- Medical conditions that are not stable
- Severe medical conditions
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?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Treatment Group
Children in the Treatment Group will receive treatment for a Trauma Focused Cognitive Behavioural Therapy Group.
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Youth may participate in trauma focused cognitive behavioural group therapy (TF-CBT)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post Traumatic Stress Disorder Symptom Severity
Time Frame: 4 Months
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PTSD symptom severity will be measured using the Child Post-Traumatic Stress Disorder Symptom Scale (CPSS)
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4 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: 4 Months
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Quality of Life will be measured using the KidKindl, a 24 item self-report questionnaire.
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4 Months
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Depression and Anxiety
Time Frame: 4 Months
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Depression and Anxiety will be measured using the Revised Children's Anxiety and Depression Scale (RCADS-Short Version)
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4 Months
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Level of Attachment
Time Frame: 4 Months
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Level of Attachment will be measured using 5 secure attachment questions on a Likert scale.
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4 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Farrel Greenspan, MC, University of Alberta
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 (Anticipated)
July 1, 2014
Primary Completion (Actual)
July 30, 2014
Study Completion (Actual)
July 30, 2014
Study Registration Dates
First Submitted
July 2, 2014
First Submitted That Met QC Criteria
July 2, 2014
First Posted (Estimate)
July 4, 2014
Study Record Updates
Last Update Posted (Actual)
December 1, 2022
Last Update Submitted That Met QC Criteria
November 28, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LW2014
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.
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