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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00073684 |
Purpose
This study will determine the necessity of including abuse-focused interventions in the treatment of sexually abused children.
| Condition | Intervention | Phase |
|---|---|---|
|
Child Abuse, Sexual |
Behavioral: Trauma focused cognitive behavioral therapy (TF-CBT) Behavioral: Brief abuse-focused treatment Behavioral: Brief coping skills treatment Behavioral: Extended abuse-focused treatment Behavioral: Extended coping skills treatment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Young Sexually Abused Children: Optimal CBT Strategies |
| Estimated Enrollment: | 240 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will receive 8 sessions of TF-CBT with narrative.
|
Behavioral: 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.
Behavioral: Brief abuse-focused treatment
Participants will receive 8 sessions of TF-CBT with abuse-focused treatment.
|
|
2: Experimental
Participants will receive 8 sessions of TF-CBT without narrative.
|
Behavioral: 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.
Behavioral: Brief coping skills treatment
Participants will receive 8 sessions of TF-CBT with brief coping skills treatment.
|
|
3: Experimental
Participants will receive 16 sessions of TF-CBT with narrative.
|
Behavioral: 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.
Behavioral: Extended abuse-focused treatment
Participants will receive 16 sessions of TF-CBT with extended abuse-focused treatment.
|
|
4: Experimental
Participants will receive 16 sessions of TF-CBT without narrative.
|
Behavioral: 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.
Behavioral: Extended coping skills treatment
Participants will receive 16 sessions of TF-CBT with extended coping skills treatment.
|
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.
Eligibility| Ages Eligible for Study: | 4 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | UMDNJ-SOM ( Esther Deblinger, PhD ) |
| Study ID Numbers: | R01 MH64776, DSIR 84-CTS |
| Study First Received: | December 2, 2003 |
| Last Updated: | August 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00073684 History of Changes |
| Health Authority: | United States: Federal Government |
|
Stress Disorders, Post-Traumatic Depression Anxiety |
|
Depression Stress Disorders, Post-Traumatic Stress Depressive Disorder Stress Disorders, Traumatic |
