Sexual Abuse of Child (If Focus of Attention is on Victim)NCT02181751
A 1-year Program to Treat Children Who Have Been Victims of Child Sexual Abuse
An observational study of Sexual Abuse of Child (If Focus of Attention is on Victim), run by Little Warriors at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Abuse of Child (If Focus of Attention is on Victim)
- What is being tested?
- Trauma Focused Cognitive Behavioural Therapy Group
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to 30 Jul 2014
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Trauma Focused Cognitive Behavioural Therapy Group
- Keywords
- Child Sexual Abuse, CSA, Treatment, Prevention, PTSD, Post Traumatic Stress Disorder, Depression, Anxiety, Quality of Life, Attachment, Cognitive Behavioural Therapy, Group Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Focused Cognitive Behavioural Therapy GroupOther
Youth may participate in trauma focused cognitive behavioural group therapy (TF-CBT)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Children in the Treatment Group will receive treatment for a Trauma Focused Cognitive Behavioural Therapy Group. Receives: Other: Trauma Focused Cognitive Behavioural Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Traumatic Stress Disorder Symptom Severity
PTSD symptom severity will be measured using the Child Post-Traumatic Stress Disorder Symptom Scale (CPSS)
Measured: 4 Months
Secondary outcomes (3)
Quality of Life
Quality of Life will be measured using the KidKindl, a 24 item self-report questionnaire.
Measured: 4 Months
Depression and Anxiety
Depression and Anxiety will be measured using the Revised Children's Anxiety and Depression Scale (RCADS-Short Version)
Measured: 4 Months
Level of Attachment
Level of Attachment will be measured using 5 secure attachment questions on a Likert scale.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startJul 2014 (estimated)
- Primary completion30 Jul 2014
- Study completion30 Jul 2014
Why it stopped: Study was never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Abuse of Child (If Focus of Attention is on Victim)Studies 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Little Warriors
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farrel Greenspan, MC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181751
- Sponsor's protocol ID
- LW2014
- Status last verified
- Nov 2022
- First submitted
- 2 Jul 2014
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1-year Program to Treat Children Who Have Been Victims of Child Sexual Abuse
- ClinicalTrials.gov ID
- NCT02181751
- Acronym / sponsor ID
- LW2014
- Keywords
- Child Sexual Abuse, CSA, Treatment, Prevention, PTSD, Post Traumatic Stress Disorder, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Little WarriorsUniversity, hospital or other
- Study start
- Jul 2014 (estimated)
- Primary completion
- 30 Jul 2014 (actual)
- Study completion
- 30 Jul 2014 (actual)
- First posted
- 4 Jul 2014 (estimated)
- 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.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Other: Trauma Focused Cognitive Behavioural Therapy GroupChildren in the Treatment Group will receive treatment for a Trauma Focused Cognitive Behavioural Therapy Group. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Trauma Focused Cognitive Behavioural Therapy GroupYouth may participate in trauma focused cognitive behavioural group therapy (TF-CBT) | Other | Treatment Group |
Primary outcome
Post Traumatic Stress Disorder Symptom Severity
Time frame: 4 Months
PTSD symptom severity will be measured using the Child Post-Traumatic Stress Disorder Symptom Scale (CPSS)
3 secondary outcomes
Quality of Life
Time frame: 4 Months
Depression and Anxiety
Time frame: 4 Months
Level of Attachment
Time frame: 4 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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.
Farrel Greenspan, MC principal investigator
University of Alberta
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 Sexual Abuse of Child (If Focus of Attention is on Victim), run by Little Warriors at 1 site in Canada.
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 1 Dec 2022. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Traumatic Stress Disorder Symptom Severity (time frame: 4 Months). 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 1 Dec 2022; AzTrials last refreshed its copy on 26 Oct 2026.