Treatment of Post-Traumatic Stress Disorder (PTSD) in Sexually Abused Children

NCT00000383 | Completed DMC

• 3 other identifiers: R10MH0559631R10MH0559631R10MH056224
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 3

Brief 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). 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.

Conditions

Stress Disorders, Post-Traumatic

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

Outcome Measures

Primary Outcomes (1)

• PTSD

  Change in child PTSD total PTSD symptoms, PTSD cluster symptoms, PTSD diagnosis as measured by the K-SADS-PL

  12 weeks; 6- and 12- month follow-up

Secondary Outcomes (8)

• Depression

  12 weeks; 6- and 12-month follow up

• Anxiety

  12 weeks; 6 and 12-month follow-up

• Maldaptive Cognitions

  12 weeks; 6 and 12 month follow-up

• Shame

  12 weeks; 6 and 12 month follow up

• Parent depression

  12 weeks; 6 and 12 month follow up

Study Arms (2)

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.

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.

Behavioral: Child-Centered Therapy

Interventions

Trauma-Focused CBT BEHAVIORAL

Structured skills, exposure, trauma-specific interventions

Also known as: TF-CBT

Trauma-Focused CBT

Child-Centered Therapy BEHAVIORAL

Client-directed supportive interventions

Also known as: CCT

Child Centered Therapy

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• \) If on psychotropic medication, not on stable dose for at least 4 weeks 5) Receiving ongoing psychotherapy outside of study

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• National Institute of Mental Health (NIMH): collaborator
• University of Medicine and Dentistry of New Jersey: collaborator

Study Sites (3)

Center for Children's Support, University of Medicine and Dentistry - New Jersey

Stratford, New Jersey, 08084, United States

Location

Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents

Pittsburgh, Pennsylvania, 15212, United States

Location

Center for Traumatic Stress in Children & Adolescents, Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (1)

• 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.

  PMID: 15187799 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Coitus; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Sexual Behavior; Behavior

Study Officials

• Judith A. Cohen, MD

  Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  PRINCIPAL INVESTIGATOR

• Esther Deblinger, PhD

  University of Medicine and Dentistry of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: September 1, 1997
• Primary Completion: September 1, 2001
• Study Completion: September 1, 2002
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

US (3)