Posttraumatic Stress DisorderNCT01649141
Trauma-Focused Cognitive Behavior Therapy for Youth: Effectiveness in a Community Setting
A study testing Trauma-Focused Cognitive Behavioral Therapy in people with Posttraumatic Stress Disorder, run by Delaware Division of Prevention and Behavioral Health Services at 1 site in United States.
Trial summary
This effectiveness study is being conducted to determine whether Trauma-Focused Cognitive Therapy (TF-CBT), a treatment model developed in specialty clinics by experts in the treatment of child sexual abuse, can be effectively transported to a state-contracted community mental health agency in the state of Delaware… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Trauma-Focused Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2012
- Phase
- Interventional
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child is 7-17 years old
- positive screen for PTSD
- child qualifies for public insurance
- parent willing to co-participate in treatment
- English-speaking (child and parent)
Who cannot join
- intellectual disability (child)
- untreated psychosis (child)
- untreated substance abuse (child)
- sibling already in study
- unable to participate in year-long follow-up (e.g., moving out of state)
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Prevention and Behavioral Health Services
Wilmington, Delaware, 19805
About this study
Official title: National Child Traumatic Stress Initiative: Community Treatment and Service Centers
This effectiveness study is being conducted to determine whether Trauma-Focused Cognitive Therapy (TF-CBT), a treatment model developed in specialty clinics by experts in the treatment of child sexual abuse, can be effectively transported to a state-contracted community mental health agency in the state of Delaware and used effectively by clinicians with little prior TF-CBT experience. The sample is comprised of youths receiving public mental health services and with diverse trauma histories.
Read the detailed description
This investigation aims to examine the effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in treating child traumatic stress when implemented in community settings on a state-wide level in Delaware. Youth (ages 7-16 years) with a history of documented trauma (sexual or physical abuse, traumatic loss, domestic or community violence) and symptoms of Posttraumatic Stress Disorder (PTSD) receive approximately 10 sessions of TF-CBT delivered in a state-contracted mental health agency. Children and adolescents are recruited from a public mental health population. PTSD symptoms and internalizing and externalizing behavior problems have been assessed in the first 72 participants at pre-treatment and then at 3-, 6-, 9-, and 12-months after intake; subsequent participants (n=38) are only being assessed for symptoms and problems at pre-treatment and then at 3-, 6-months after intake.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Trauma-Focused Cognitive Behavioral Therapy
- Keywords
- posttraumatic stress disorder, trauma-focused cognitive behavioral therapy, trauma, child abuse
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Focused Cognitive Behavioral TherapyBehavioural
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is a structured, 12-16 session outpatient intervention originally developed to treat Posttraumatic Stress Disorder (PTSD) and related emotional and behavioral difficulties in youth with a history of child sexual abuse. TF-CBT's eight components are delivered in 90-minute weekly sessions split evenly between children and their parents. These components are summarized by the acronym PRACTICE including: psychoeducation and parenting skills (P), relaxation (R), affective expression and regulation (A), cognitive coping (C), trauma narrative development and processing (T), in vivo gradual exposure (I), conjoint parent/child sessions (C) and enhancing safety and future development (E).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Trauma-Focused Cognitive Behavioral Therapy Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline PTSD Symptoms at 3-,6-,9- and 12-months
PTSD symptoms area assessed with the UCLA PTSD Reaction Index for DSM-IV (UPID). The UPID (Pynoos, et al., 1998) includes 48 items that can be administered as a questionnaire or structured interview. The instrument's three sections assess for trauma exposure and symptoms of DSM-IV PTSD in children ages 7-18. The UPID has good convergent validity (i.e., 0.70 in comparison to the K-SADS, epidemiologic version), a sensitivity of 0.93 and specificity of 0.87 in diagnosing PTSD (Steinberg et al., 2004), and test-retest reliability of 0.84 (Steinberg et al., 2004)
Measured: Baseline and post-baseline (3-,6-,9-,12-months)
Secondary outcomes (1)
Change in baseline behavioral problems at 3-, 6-, 9- and 12-months.
Behavioral problems are assessed with the parent version of the Child Behavior Checklist 6-18 (CBCL: Achenbach, \& Rescorla, 2001)\.The CBCL is a 113-item parent self-report measure used to assess children's emotional and behavioral problems and social competencies. The CBCL has been used with acceptable levels of reliability (range 0.84-0.98) and content and criterion validity to measure mental health problems of children ages 6-18 years from diverse racial and ethnic backgrounds (Achenbach \& Rescorla, 2001).
Measured: Baseline and post-baseline (3-,6-,9-,12-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startAug 2006
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delaware Division of Prevention and Behavioral Health Services
- Sponsor type
- Other government
- Collaborators
- University of Medicine and Dentistry of New Jersey, University of Delaware
- Responsible party
- Sponsor
- Investigators
- Charles P Webb, Ph.D., Study director, Division of Prevention and Behavioral Health ServicesNancy Widdoes, M.A., Principal investigator, Division of Prevention and Behavioral Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649141
- Sponsor's protocol ID
- SM57145
- Status last verified
- Jul 2012
- First submitted
- 19 Jul 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Child Traumatic Stress Initiative: Community Treatment and Service Centers
- ClinicalTrials.gov ID
- NCT01649141
- Acronym / sponsor ID
- SM57145
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- posttraumatic stress disorder, trauma-focused cognitive behavioral therapy, trauma, child abuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Delaware Division of Prevention and Behavioral Health ServicesOther government
- Collaborators
- University of Medicine and Dentistry of New Jersey, University of Delaware
- Study start
- Aug 2006
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 25 Jul 2012 (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.
This effectiveness study is being conducted to determine whether Trauma-Focused Cognitive Therapy (TF-CBT), a treatment model developed in specialty clinics by experts in the treatment of child sexual abuse, can be effectively transported to a state-contracted community mental health agency in the state of Delaware and used effectively by clinicians with little prior TF-CBT experience. The sample is comprised of youths receiving public mental health services and with diverse trauma histories.
Detailed description
This investigation aims to examine the effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in treating child traumatic stress when implemented in community settings on a state-wide level in Delaware. Youth (ages 7-16 years) with a history of documented trauma (sexual or physical abuse, traumatic loss, domestic or community violence) and symptoms of Posttraumatic Stress Disorder (PTSD) receive approximately 10 sessions of TF-CBT delivered in a state-contracted mental health agency. Children and adolescents are recruited from a public mental health population. PTSD symptoms and internalizing and externalizing behavior problems have been assessed in the first 72 participants at pre-treatment and then at 3-, 6-, 9-, and 12-months after intake; subsequent participants (n=38) are only being assessed for symptoms and problems at pre-treatment and then at 3-, 6-months after intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Trauma-Focused Cognitive Behavioral TherapyTrauma-Focused Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- child is 7-17 years old
- positive screen for PTSD
- child qualifies for public insurance
- parent willing to co-participate in treatment
- English-speaking (child and parent)
Key exclusion criteria (5 listed)
- intellectual disability (child)
- untreated psychosis (child)
- untreated substance abuse (child)
- sibling already in study
- unable to participate in year-long follow-up (e.g., moving out of state)
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 Behavioral TherapyTrauma-Focused Cognitive Behavioral Therapy (TF-CBT) is a structured, 12-16 session outpatient intervention originally developed to treat Posttraumatic Stress Disorder (PTSD) and related emotional and behavioral difficulties in youth with a history of child sexual abuse. TF-CBT's eight components are delivered in 90-minute weekly sessions split evenly between children and their parents. These components are summarized by the acronym PRACTICE including: psychoeducation and parenting skills (P), relaxation (R), affective expression and regulation (A), cognitive coping (C), trauma narrative development and processing (T), in vivo gradual exposure (I), conjoint parent/child sessions (C) and enhancing safety and future development (E). | Behavioural | Treatment Group |
Primary outcome
Change in baseline PTSD Symptoms at 3-,6-,9- and 12-months
Time frame: Baseline and post-baseline (3-,6-,9-,12-months)
PTSD symptoms area assessed with the UCLA PTSD Reaction Index for DSM-IV (UPID). The UPID (Pynoos, et al., 1998) includes 48 items that can be administered as a questionnaire or structured interview. The instrument's three sections assess for trauma exposure and symptoms of DSM-IV PTSD in children ages 7-18. The UPID has good convergent validity (i.e., 0.70 in comparison to the K-SADS, epidemiologic version), a sensitivity of 0.93 and specificity of 0.87 in diagnosing PTSD (Steinberg et al., 2004), and test-retest reliability of 0.84 (Steinberg et al., 2004)
1 secondary outcome
Change in baseline behavioral problems at 3-, 6-, 9- and 12-months.
Time frame: Baseline and post-baseline (3-,6-,9-,12-months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
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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.
Charles P Webb, Ph.D. study director
Division of Prevention and Behavioral Health Services
Nancy Widdoes, M.A. principal investigator
Division of Prevention and Behavioral Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Focused Cognitive Behavioral Therapy in people with Posttraumatic Stress Disorder, run by Delaware Division of Prevention and Behavioral Health Services 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 5 inclusion and 5 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 25 Jul 2012. 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?
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?
Change in baseline PTSD Symptoms at 3-,6-,9- and 12-months (time frame: Baseline and post-baseline (3-,6-,9-,12-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 25 Jul 2012.