Stress Disorders, Post-TraumaticNCT00000383
Treatment of Post-Traumatic Stress Disorder (PTSD) in Sexually Abused Children
A study testing Trauma-Focused CBT and Child-Centered Therapy in people with Stress Disorders, Post-Traumatic, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 3 sites in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two psychological therapies used to treat PTSD in children who have recently been sexually abused: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT). Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Trauma-Focused CBT and Child-Centered Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 1997to Sep 2002
- 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -
- Patients must have:
- Post-Traumatic Stress Disorder (PTSD) symptoms (at least 5 with at least one symptom in each of 3 PTSD clusters) related to sexual abuse
- Confirmed child sexual abuse history
- Speak English
- Parent willing to participate in treatment
Who cannot join
- Active psychotic disorder resulting in inability to participate in CBT
- Active substance abuse disorder that resulted in significant impairment 3 Serious developmental disorder precluding participation in CBT
- 4) If on psychotropic medication, not on stable dose for at least 4 weeks 5) Receiving ongoing psychotherapy outside of study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
Pittsburgh, Pennsylvania, 15212
Center for Traumatic Stress in Children & Adolescents, Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Center for Children's Support, University of Medicine and Dentistry - New Jersey
Stratford, New Jersey, 08084
About this study
Official title: Treatment of PTSD in Sexually Abused Children
The purpose of this study is to compare the effectiveness of two psychological therapies used to treat PTSD in children who have recently been sexually abused: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT).
Child sexual abuse is a common experience that has serious mental health consequences, including the development of PTSD and other abuse-related problems.
Read more
All children will be assigned randomly (like tossing a coin) to receive either SAS-CBT or NST at each of two sites. In addition, the parents and the child will receive individual therapy for 12 weeks. The child will be monitored to evaluate his/her response to therapy. Assessments will take place before and just following treatment, and then 6 and 12 months post-treatment.
A child may be eligible for this study if he/she:
Has been sexually abused, is suffering from PTSD as a result of the abuse, and is 8 to 14 years old.
Read the detailed description
To evaluate the comparative efficacy of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT) in decreasing symptoms of Post-Traumatic Stress Disorder (PTSD) following recent sexual abuse.
Child sexual abuse is a common experience that has serious mental health consequences, including the development of PTSD and other abuse-related and general psychopathological symptoms.
Patients are randomly assigned to receive either TF-CBT or CCT at each of two sites, and will be provided with 12 weeks of individual therapy for children and parents. Treatment is monitored for compliance with the respective treatment models through intensive supervision, audiotaping of sessions, rating of sessions with use of adherence checklists, and independent blind rating of audiotapes. Treatment outcome is evaluated through the use of several self-, parent-, and teacher-report standardized instruments, administered at pre- and post-treatment, and follow-up evaluations at 6 and 12 months. The project also assesses differential treatment impact by gender and ethnicity, and attempts to evaluate the impact of specific components of the treatment process in mediating treatment outcome. Specifically, the project evaluates the differential effectiveness of the two treatment modalities in improving the subject's abuse-related attributions and perceptions, parenting practices, familial adaptability and cohesiveness, parent support, and parental emotional reaction to the abuse, and the impact of improving these variables on treatment outcome.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Trauma-Focused CBT, Child-Centered Therapy
- Keywords
- Adolescence, Child, Cognitive Therapy, Comparative Study, Female, Human, Male, Stress Disorders, Post-Traumatic, Child Abuse, Sexual, Stress Disorders, Post-Traumatic -- *therapy, Child Abuse, Sexual -- *psychology
- Medical subject headings
- Stress Disorders, Post-Traumatic, Coitus, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Focused CBTBehavioural
Also called TF-CBT
Structured skills, exposure, trauma-specific interventions
Child-Centered TherapyBehavioural
Also called CCT
Client-directed supportive interventions
| Study group | Role | What they receive |
|---|---|---|
| Trauma-Focused CBT | Experimental | Trauma -Focused CBT provides 12 sessions (45 minutes child, 45 minutes parent) of CBT treatment. This includes therapist-directed trauma-focused skills training, exposure, parenting, conjoint parent-child sessions, and safety component provided to child and parent. Receives: Behavioral: Trauma-Focused CBT |
| Child Centered Therapy | Active comparator | Child Centered Therapy provides 12 sessions (45 minutes child, 45 minutes parent) of supportive interventions. This includes client-directed activities focused on the needs and interests of the child or parent, respectively. Receives: Behavioral: Child-Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD
Change in child PTSD total PTSD symptoms, PTSD cluster symptoms, PTSD diagnosis as measured by the K-SADS-PL
Measured: 12 weeks; 6- and 12- month follow-up
Secondary outcomes (8)
Depression
Change in child depressive symptoms measured by the Child Depression Inventory
Measured: 12 weeks; 6- and 12-month follow up
Anxiety
Change in child anxiety symptoms measured by State Trait Anxiety Inventory
Measured: 12 weeks; 6 and 12-month follow-up
Maldaptive Cognitions
Change in maladaptive trauma-related cognitions measured by the Children'sAttributions and Perceptions Scale
Measured: 12 weeks; 6 and 12 month follow-up
Shame
Change in child shame measured by SHAME scale
Measured: 12 weeks; 6 and 12 month follow up
Parent depression
Change in parental depression measured by Beck Depression Inventory
Measured: 12 weeks; 6 and 12 month follow up
Parent Emotional Distress
Change in parental distress related to child's abuse measured by Parental Emotional Reaction Questionnaire
Measured: 12 weeks; 6 and 12 month follow up
Parental Support
Change in parental support of child measured by Parental Support Questionnaire
Measured: 12 weeks; 6 and 12 month follow up
Positive Parenting Practices
Change in positive parenting measured by Parenting Practices Questionnaire
Measured: 12 weeks; 6 and 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startSep 1997
- Primary completionSep 2001
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Medicine and Dentistry of New Jersey
- Responsible party
- Principal investigator, Judith Cohen, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Judith A. Cohen, MD, Principal investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Esther Deblinger, PhD, Principal investigator, University of Medicine and Dentistry of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000383
- Sponsor's protocol ID
- R10MH055963
- Other IDs
- 1R10MH055963, 1R10MH056224
- Status last verified
- Mar 2015
- First submitted
- 2 Nov 1999
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cohen JA, Deblinger E, Mannarino AP, Steer RA. A multisite, randomized controlled trial for children with sexual abuse-related PTSD symptoms. J Am Acad Child Adolesc Psychiatry. 2004 Apr;43(4):393-402. doi: 10.1097/00004583-200404000-00005.
PubMed 15187799
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of PTSD in Sexually Abused Children
- ClinicalTrials.gov ID
- NCT00000383
- Acronym / sponsor ID
- R10MH055963
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Adolescence, Child, Cognitive Therapy, Comparative Study, Female, Human, Male, Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Medicine and Dentistry of New Jersey
- Study start
- Sep 1997
- Primary completion
- Sep 2001 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 3 Nov 1999 (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.
The purpose of this study is to compare the effectiveness of two psychological therapies used to treat PTSD in children who have recently been sexually abused: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT).
Child sexual abuse is a common experience that has serious mental health consequences, including the development of PTSD and other abuse-related problems.
All children will be assigned randomly (like tossing a coin) to receive either SAS-CBT or NST at each of two sites. In addition, the parents and the child will receive individual therapy for 12 weeks. The child will be monitored to evaluate his/her response to therapy. Assessments will take place before and just following treatment, and then 6 and 12 months post-treatment.
A child may be eligible for this study if he/she:
Has been sexually abused, is suffering from PTSD as a result of the abuse, and is 8 to 14 years old.
Detailed description
To evaluate the comparative efficacy of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT) in decreasing symptoms of Post-Traumatic Stress Disorder (PTSD) following recent sexual abuse.
Child sexual abuse is a common experience that has serious mental health consequences, including the development of PTSD and other abuse-related and general psychopathological symptoms.
Patients are randomly assigned to receive either TF-CBT or CCT at each of two sites, and will be provided with 12 weeks of individual therapy for children and parents. Treatment is monitored for compliance with the respective treatment models through intensive supervision, audiotaping of sessions, rating of sessions with use of adherence checklists, and independent blind rating of audiotapes. Treatment outcome is evaluated through the use of several self-, parent-, and teacher-report standardized instruments, administered at pre- and post-treatment, and follow-up evaluations at 6 and 12 months. The project also assesses differential treatment impact by gender and ethnicity, and attempts to evaluate the impact of specific components of the treatment process in mediating treatment outcome. Specifically, the project evaluates the differential effectiveness of the two treatment modalities in improving the subject's abuse-related attributions and perceptions, parenting practices, familial adaptability and cohesiveness, parent support, and parental emotional reaction to the abuse, and the impact of improving these variables on treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma-Focused CBT | Experimental | Behavioral: Trauma-Focused CBTTrauma -Focused CBT provides 12 sessions (45 minutes child, 45 minutes parent) of CBT treatment. This includes therapist-directed trauma-focused skills training, exposure, parenting, conjoint parent-child sessions, and safety component provided to child and parent. |
| Child Centered Therapy | Active comparator | Behavioral: Child-Centered TherapyChild Centered Therapy provides 12 sessions (45 minutes child, 45 minutes parent) of supportive interventions. This includes client-directed activities focused on the needs and interests of the child or parent, respectively. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- -
- Post-Traumatic Stress Disorder (PTSD) symptoms (at least 5 with at least one symptom in each of 3 PTSD clusters) related to sexual abuse
- Confirmed child sexual abuse history
- Speak English
- Parent willing to participate in treatment
Key exclusion criteria (3 listed)
- Active psychotic disorder resulting in inability to participate in CBT
- Active substance abuse disorder that resulted in significant impairment 3 Serious developmental disorder precluding participation in CBT
- 4) If on psychotropic medication, not on stable dose for at least 4 weeks 5) Receiving ongoing psychotherapy outside of study
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 CBTAlso: TF-CBTStructured skills, exposure, trauma-specific interventions | Behavioural | Trauma-Focused CBT |
| Child-Centered TherapyAlso: CCTClient-directed supportive interventions | Behavioural | Child Centered Therapy |
Primary outcome
PTSD
Time frame: 12 weeks; 6- and 12- month follow-up
Change in child PTSD total PTSD symptoms, PTSD cluster symptoms, PTSD diagnosis as measured by the K-SADS-PL
8 secondary outcomes
Depression
Time frame: 12 weeks; 6- and 12-month follow up
Anxiety
Time frame: 12 weeks; 6 and 12-month follow-up
Maldaptive Cognitions
Time frame: 12 weeks; 6 and 12 month follow-up
Shame
Time frame: 12 weeks; 6 and 12 month follow up
Parent depression
Time frame: 12 weeks; 6 and 12 month follow up
Parent Emotional Distress
Time frame: 12 weeks; 6 and 12 month follow up
Parental Support
Time frame: 12 weeks; 6 and 12 month follow up
Positive Parenting Practices
Time frame: 12 weeks; 6 and 12 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- Background: PubMed 15187799Cohen JA, Deblinger E, Mannarino AP, Steer RA. A multisite, randomized controlled trial for children with sexual abuse-related PTSD symptoms. J Am Acad Child Adolesc Psychiatry. 2004 Apr;43(4):393-402. doi: 10.1097/00004583-200404000-00005.
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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.
Judith A. Cohen, MD principal investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Esther Deblinger, PhD principal investigator
University of Medicine and Dentistry of New Jersey
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Focused CBT and Child-Centered Therapy in people with Stress Disorders, Post-Traumatic, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 3 sites 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PTSD (time frame: 12 weeks; 6- and 12- month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000383, which also lists 1 linked publication.
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 30 Mar 2015.