Child Abuse, SexualPhase 3NCT00073684
Optimal Treatment Strategies for Sexually Abused Children
A Phase 3 study testing Trauma focused cognitive behavioral therapy (TF-CBT), Brief abuse-focused treatment and Brief coping skills treatment in people with Child Abuse, Sexual, run by Rowan University at 1 site in United States.
Trial summary
This study will determine the necessity of including abuse-focused interventions in the treatment of sexually abused children. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Child Abuse, Sexual
- What is being tested?
- Trauma focused cognitive behavioral therapy (TF-CBT), Brief abuse-focused treatment and Brief coping skills treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jul 2009
- Phase
- Phase 3
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sexual abuse that has occurred within 24 months of the study. The abuse must have been substantiated by child protective services, charges must have been pressed by the prosecutor's office, or there must have been independent confirmation of abuse by a professional with recognized expertise in conducting investigative evaluations.
- Kiddie-Sads-Present and Lifetime Version (K-SADS-PL) criteria for partial or full post-traumatic stress disorder (PTSD)
- Parental consent
- Caretaker who has not abused the child
Who cannot join
- Mental Retardation (IQ less than 70) or placement in special education classes
- DSM-IV criteria for Pervasive Developmental Disorders
- Psychotic disorder
- Serious medical illness that could interfere with the study
- In temporary, emergency foster care. If a child is returned home or placed in short-term foster care that is anticipated to last a minimum of 4 months, then the child is eligible for participation.
- Parent who meets DSM-IV criteria for a psychotic disorder
Show all 9Show fewer
- Parents with serious mental health problems that result in substantial functional impairment
- Unsupervised contact with abuse perpetrator
- Receiving concurrent psychiatric treatment for the abuse. If participants previously received sexual abuse treatment that did not resolve symptomology, they are eligible to participate. In addition, children who have contact with a psychiatrist for medication monitoring purposes may be included if their medication and dosage have remained stable for at least 6 weeks prior to study start
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Young Sexually Abused Children: Optimal CBT Strategies
This study will determine the necessity of including abuse-focused interventions in the treatment of sexually abused children.
Read the detailed description
Child sexual abuse is a serious public health problem that places children at high risk for developing anxiety, mood, conduct, sexual, and substance abuse disorders. It also increases their likelihood of experiencing further victimization. It is imperative that abused children are provided with effective interventions to minimize their risk of developing problems that can be disruptive to their psychosocial development. Evidence suggests that cognitive behavioral therapy (CBT) can effectively ameliorate many abuse-related symptoms exhibited by sexually abused children and their parents. However, it is unknown whether CBT treatment should include gradual exposure (GE), an intervention that involves the gradual confrontation of abuse-related thoughts and memories with therapist feedback to assist the child in effectively processing the abusive experience. Because this component of CBT may be more difficult for children and their parents, it is important to determine if and when GE is essential for optimal recovery in abused children.
Children and their parents will be randomly assigned to receive one of four treatments: brief abuse-focused treatment, brief coping skills treatment, extended abuse-focused treatment, and extended coping skills treatment. Assessments will be conducted before, during, and after treatment and at 6- and 12-month follow-up visits. Standardized evaluations will be conducted to assess parents' distress and support levels; parent reports of children's behavior patterns, sexualized behaviors, and post-traumatic stress disorder (PTSD) symptoms; and children's self-reports of PTSD, depression and anxiety symptoms, body safety skills, and victimization experiences.
- Conditions
- Child Abuse, Sexual
- Being tested
- Trauma focused cognitive behavioral therapy (TF-CBT), Brief abuse-focused treatment, Brief coping skills treatment, Extended abuse-focused treatment, Extended coping skills treatment
- Keywords
- Stress Disorders, Post-Traumatic, Depression, Anxiety
- Medical subject headings
- Coitus, 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 behavioral therapy (TF-CBT)Behavioural
This study aims to: (1) examine the differential effects of CBT with and without trauma narrative interventions; (2) examine the comparative efficacy of brief and extended (8 vs. 16 sessions) individual CBT; (3) make developmental comparisons between 4-7 year olds and 8-11 year olds as to the appropriateness and therapeutic necessity of exposure interventions and longer treatment; and (4) identify child and parent factors that may significantly mediate the relationships between treatment conditions and outcomes. The findings of this study will help establish clinical as well as developmental markers for the early identification of sexually abused children who may require more focused (i.e., including trauma narrative) and/or longer treatment to achieve optimal outcomes.
Brief abuse-focused treatmentBehavioural
Participants will receive 8 sessions of TF-CBT with abuse-focused treatment.
Brief coping skills treatmentBehavioural
Participants will receive 8 sessions of TF-CBT with brief coping skills treatment.
Extended abuse-focused treatmentBehavioural
Participants will receive 16 sessions of TF-CBT with extended abuse-focused treatment.
Extended coping skills treatmentBehavioural
Participants will receive 16 sessions of TF-CBT with extended coping skills treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive 8 sessions of TF-CBT with narrative. Receives: Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT); Behavioral: Brief abuse-focused treatment |
| 2 | Experimental | Participants will receive 8 sessions of TF-CBT without narrative. Receives: Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT); Behavioral: Brief coping skills treatment |
| 3 | Experimental | Participants will receive 16 sessions of TF-CBT with narrative. Receives: Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT); Behavioral: Extended abuse-focused treatment |
| 4 | Experimental | Participants will receive 16 sessions of TF-CBT without narrative. Receives: Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT); Behavioral: Extended coping skills treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
K-SADS-PL PTSD
Measured: Measured at Months 6 and 12
Secondary outcomes (1)
Child Depression Inventory (CDI)
Measured: Measured at Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2003 (estimated)
- Study startAug 2003
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Abuse, SexualStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073684
- Sponsor's protocol ID
- R01MH064776
- Other IDs
- R01MH064776, DSIR 84-CTS
- Status last verified
- May 2014
- First submitted
- 2 Dec 2003
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Sexually Abused Children: Optimal CBT Strategies
- ClinicalTrials.gov ID
- NCT00073684
- Acronym / sponsor ID
- R01MH064776
- Conditions
- Child Abuse, Sexual
- Keywords
- Stress Disorders, Post-Traumatic, Depression, Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2003
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 Dec 2003 (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 study will determine the necessity of including abuse-focused interventions in the treatment of sexually abused children.
Detailed description
Child sexual abuse is a serious public health problem that places children at high risk for developing anxiety, mood, conduct, sexual, and substance abuse disorders. It also increases their likelihood of experiencing further victimization. It is imperative that abused children are provided with effective interventions to minimize their risk of developing problems that can be disruptive to their psychosocial development. Evidence suggests that cognitive behavioral therapy (CBT) can effectively ameliorate many abuse-related symptoms exhibited by sexually abused children and their parents. However, it is unknown whether CBT treatment should include gradual exposure (GE), an intervention that involves the gradual confrontation of abuse-related thoughts and memories with therapist feedback to assist the child in effectively processing the abusive experience. Because this component of CBT may be more difficult for children and their parents, it is important to determine if and when GE is essential for optimal recovery in abused children.
Children and their parents will be randomly assigned to receive one of four treatments: brief abuse-focused treatment, brief coping skills treatment, extended abuse-focused treatment, and extended coping skills treatment. Assessments will be conducted before, during, and after treatment and at 6- and 12-month follow-up visits. Standardized evaluations will be conducted to assess parents' distress and support levels; parent reports of children's behavior patterns, sexualized behaviors, and post-traumatic stress disorder (PTSD) symptoms; and children's self-reports of PTSD, depression and anxiety symptoms, body safety skills, and victimization experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT), Behavioral: Brief abuse-focused treatmentParticipants will receive 8 sessions of TF-CBT with narrative. |
| 2 | Experimental | Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT), Behavioral: Brief coping skills treatmentParticipants will receive 8 sessions of TF-CBT without narrative. |
| 3 | Experimental | Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT), Behavioral: Extended abuse-focused treatmentParticipants will receive 16 sessions of TF-CBT with narrative. |
| 4 | Experimental | Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT), Behavioral: Extended coping skills treatmentParticipants will receive 16 sessions of TF-CBT without narrative. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Sexual abuse that has occurred within 24 months of the study. The abuse must have been substantiated by child protective services, charges must have been pressed by the prosecutor's office, or there must have been independent confirmation of abuse by a professional with recognized expertise in conducting investigative evaluations.
- Kiddie-Sads-Present and Lifetime Version (K-SADS-PL) criteria for partial or full post-traumatic stress disorder (PTSD)
- Parental consent
- Caretaker who has not abused the child
Key exclusion criteria (9 listed)
- Mental Retardation (IQ less than 70) or placement in special education classes
- DSM-IV criteria for Pervasive Developmental Disorders
- Psychotic disorder
- Serious medical illness that could interfere with the study
- In temporary, emergency foster care. If a child is returned home or placed in short-term foster care that is anticipated to last a minimum of 4 months, then the child is eligible for participation.
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 therapy (TF-CBT)This study aims to: (1) examine the differential effects of CBT with and without trauma narrative interventions; (2) examine the comparative efficacy of brief and extended (8 vs. 16 sessions) individual CBT; (3) make developmental comparisons between 4-7 year olds and 8-11 year olds as to the appropriateness and therapeutic necessity of exposure interventions and longer treatment; and (4) identify child and parent factors that may significantly mediate the relationships between treatment conditions and outcomes. The findings of this study will help establish clinical as well as developmental markers for the early identification of sexually abused children who may require more focused (i.e., including trauma narrative) and/or longer treatment to achieve optimal outcomes. | Behavioural | 1, 2, 3, 4 |
| Brief abuse-focused treatmentParticipants will receive 8 sessions of TF-CBT with abuse-focused treatment. | Behavioural | 1 |
| Brief coping skills treatmentParticipants will receive 8 sessions of TF-CBT with brief coping skills treatment. | Behavioural | 2 |
| Extended abuse-focused treatmentParticipants will receive 16 sessions of TF-CBT with extended abuse-focused treatment. | Behavioural | 3 |
| Extended coping skills treatmentParticipants will receive 16 sessions of TF-CBT with extended coping skills treatment. | Behavioural | 4 |
Primary outcome
K-SADS-PL PTSD
Time frame: Measured at Months 6 and 12
1 secondary outcome
Child Depression Inventory (CDI)
Time frame: Measured at Months 6 and 12
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 8 May 2014.
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Partner
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trauma focused cognitive behavioral therapy (TF-CBT), Brief abuse-focused treatment and Brief coping skills treatment in people with Child Abuse, Sexual, run by Rowan University 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 4 inclusion and 9 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 8 May 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
K-SADS-PL PTSD (time frame: Measured at Months 6 and 12). 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 8 May 2014.