NCT02181751

Brief 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2014

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2014

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

29 days

First QC Date

July 2, 2014

Last Update Submit

November 28, 2022

Conditions

Keywords

Child Sexual AbuseCSATreatmentPreventionPTSDPost Traumatic Stress DisorderDepressionAnxietyQuality of LifeAttachmentCognitive Behavioural TherapyGroup Therapy

Outcome Measures

Primary Outcomes (1)

  • Post Traumatic Stress Disorder Symptom Severity

    PTSD symptom severity will be measured using the Child Post-Traumatic Stress Disorder Symptom Scale (CPSS)

    4 Months

Secondary Outcomes (3)

  • Quality of Life

    4 Months

  • Depression and Anxiety

    4 Months

  • Level of Attachment

    4 Months

Study Arms (1)

Treatment Group

Children in the Treatment Group will receive treatment for a Trauma Focused Cognitive Behavioural Therapy Group.

Other: Trauma Focused Cognitive Behavioural Therapy Group

Interventions

Youth may participate in trauma focused cognitive behavioural group therapy (TF-CBT)

Treatment Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Be Brave Ranch

Ardrossan, Alberta, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Farrel Greenspan, MC

    University of Alberta

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 4, 2014

Study Start

July 1, 2014

Primary Completion

July 30, 2014

Study Completion

July 30, 2014

Last Updated

December 1, 2022

Record last verified: 2022-11

Locations