Treatment Trials

18 Clinical Trials for Various Conditions

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COMPLETED
Body-Oriented Therapy for Sexual Abuse Recovery
Description

The purpose of this study is to examine and compare the effects of two body therapy approaches in women who have experienced child sexual abuse.

COMPLETED
Optimal Treatment Strategies for Sexually Abused Children
Description

This study will determine the necessity of including abuse-focused interventions in the treatment of sexually abused children.

RECRUITING
Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children
Description

The overall goal of the five-year project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Project (SMFP)'s READY to Stand (RTS)© curriculum with an eye toward widespread dissemination to other U.S. communities, if deemed effective. Broadly, the investigators seek to determine the effect participation has on students: reductions in commercial sexual exploitation of children (CSEC) perpetration (the primary outcome); reductions in CSEC victimization, teen dating violence (TDV), and sexual violence victimization and perpetration; as well as increases in bystander intervention in CSEC situations compared to participants in the control condition (secondary outcomes).

COMPLETED
Preventing Commercial Sexual Exploitation of Children
Description

The overall goal of the 5-year project is to conduct both a process and rigorous outcome evaluation of The Set Me Free Projects (SMFP) READY to Stand (RTS) curriculum with an eye toward widespread dissemination to other U.S. communities, if deemed effective.

COMPLETED
Adult Sexual Risk Behavior Among Women With a History of Childhood Sexual Abuse
Description

This study will evaluate whether childhood experiences are related to current sexual behavior of adult women.

COMPLETED
Group Therapies for Reducing HIV-risk Behavior in Women Who Have Survived Childhood Sexual Abuse
Description

This study will evaluate the effectiveness of trauma-focused group therapy for reducing HIV-risk behavior and revictimization among adult women survivors of childhood sexual abuse (CSA).

COMPLETED
Brief Integrative Therapy for Post-Traumatic Stress Disorder
Description

The purpose of this study is to refine Brief Integrative Therapy (BIT) and to evaluate its effectiveness in treating women with Post-Traumatic Stress Disorder (PTSD) following childhood sexual abuse. This study will also promote the development of skills that are necessary for increasing quality of life and improving self-esteem.

COMPLETED
Treatment of Depressed Women Who Have Been Sexually Abused
Description

The purpose of this study is to compare Schema-Focused Therapy plus antidepressant medication and antidepressant medication alone for the treatment of major depression in women with a history of childhood sexual abuse.

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

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.

TERMINATED
Maximizing the Reach of Universal Child Sexual Abuse Prevention: An Equivalence Trial
Description

The goal of this clinical trial is to test the equivalence of two delivery modalities of a universal child sexual abuse prevention program, Safe Touches: usual vs. modified. The aims are to: 1. Determine the equivalence of effectiveness between usual and modified Safe Touches 2. Assess the maintenance of gains between usual and modified Safe Touches 3. Examine factors that may impact the future dissemination and implementation

RECRUITING
Tertiary Prevention of Child Sexual Abuse
Description

This is a feasibility study designed to inform the development of a multinational study of the effectiveness of a tertiary prevention program for child sexual abuse. This study targets adult men who have engaged in child sexual abuse, and will be implemented within the Minnesota Department of Corrections. Data will include measures of the implementation process, short-terms changes in criminogenic factors, and staff and participant factors that could influence outcomes.

RECRUITING
Parent-focused Primary Prevention of Child Sexual Abuse: An Effectiveness-implementation Hybrid Trial
Description

The goal of this clinical trial is to test the effectiveness of a parent-focused child sexual abuse prevention program (Smart Parents) delivered to parents enrolled in a parent education program (Parents as Teachers; PAT). The main questions the trial aims to answer are: 1. Does PAT + Smart Parents improve parents' CSA-related awareness and protective behaviors compared to PAT as usual? 2. Are potential gains maintained 12- and 24-months post intervention? 3. What parent-, provider-, and organizational-level factors hold promise for future dissemination and implementation efforts?

ENROLLING_BY_INVITATION
Evaluation of HRP Among Pre-K Through 5th Grade
Description

This study is a rigorous experimental evaluation of an existing manualized universal child sexual abuse primary prevention program with a history of 30+ years of implementation across 30 states and robust pilot data.

COMPLETED
Smart Parents--Safe and Healthy Kids
Description

The purpose of the proposed study is to assess the effectiveness of the addition of a single-session child sexual abuse (CSA) prevention module (Smart Parents - Safe and Healthy Kids) on improving parents' knowledge, attitudes, and behaviors regarding CSA prevention for parents already receiving parent-education services. The investigators hypothesize that parents who receive the parenting curriculum and the CSA prevention module will (a) demonstrate significant improvement in CSA-related awareness (i.e., knowledge, attitudes) and protective behaviors from pre-test to post-test, and (b) demonstrate higher scores on CSA-related awareness and protective behaviors as compared to parents who only receive the parenting curriculum.

COMPLETED
Safe Touches: A Rigorous Evaluation of a Sexual Abuse Prevention Program for Children
Description

The primary goal of the study is to conduct a rigorous evaluation of the sexual abuse prevention program entitled, "Safe Touches: Personal Safety Training for Children (Safe Touches)." The main study hypothesis is that children who receive the Safe Touches intervention will show greater improvement on their knowledge of inappropriate touches compared to children who do not receive the intervention.

RECRUITING
Help Wanted: Evaluating a Prevention Intervention for People With Sexual Interest in Children
Description

This project aims to evaluate the Help Wanted Prevention Intervention, an online program to provide people with a sexual attraction to children the skills and resources to support their commitment to keep children safe and to improve the participants well-being. In phase one, ten men with a sexual attraction to children who have never had a contact offense with a child will be asked to go through an abbreviated version of the participant procedures that will be used in study phase two (described next). Specifically, the ten participants will complete one of the online surveys, review the Help Wanted program, and participate in a 30-60 minute anonymous audio call with a member of the study team to provide feedback on the study procedures and materials (e.g., consent form, recruitment form). Feedback from phase one will inform changes to study procedures for phase two. Phase two consists of a large-scale evaluation of the Help Wanted program. Three hundred men with a sexual attraction to children who have never had a contact offense with a child or accessed the Help Wanted Program will be randomly selected to be part of one of two groups: the program group (N = 200) or the control group (N = 100). Both groups will be asked to complete an online survey before reviewing the Help Wanted Program, provide feedback on the program over a one-month period, and complete another online survey immediately after reviewing the program and three months after reviewing the program. Participants in the control group will have a one month waiting period after the first online survey, during which the participants will receive alternative resources and supports for mental health and sexual attraction to children. After the one month waiting period, participants in the control group will complete one additional online survey before reviewing the Help Wanted program and completing the two final online surveys (one immediately after reviewing the program, one three months after reviewing the program). Survey questions will ask about participants thoughts, feelings, and behaviors, including questions about the participants overall well-being and sexual attraction to children. All study materials and resources are in English. Resources provided to participants are also in English, but provide services in over 30 countries to include participants who may reside in countries outside of the United States. Participation is anonymous and all data will be kept confidential.

ACTIVE_NOT_RECRUITING
Fostering Healthy Futures for Teens: An RCT
Description

This study will implement and evaluate a mentoring program designed to promote positive youth development and reduce adverse outcomes among maltreated adolescents with open child welfare cases. Teenagers who have been maltreated are at heightened risk for involvement in delinquency, substance use, and educational failure as a result of disrupted attachments with caregivers and exposure to violence within their homes and communities. Although youth mentoring is a widely used prevention approach nationally, it has not been rigorously studied for its effects in preventing these adverse outcomes among maltreated youth involved in the child welfare system. This randomized controlled trial will permit us to implement and evaluate the Fostering Healthy Futures for Teens (FHF-T) program, which will use mentoring and skills training within an innovative positive youth development (PYD) framework to promote adaptive functioning and prevent adverse outcomes. Graduate student mentors will deliver 9 months of prevention programming in teenagers' homes and communities. Mentors will focus on helping youth set and reach goals that will improve their functioning in five targeted "REACH" domains: Relationships, Education, Activities, Career, and Health. In reaching those goals, mentors will help youth build social-emotional skills associated with preventing adverse outcomes (e.g., emotion regulation, communication, problem solving). The randomized controlled trial will enroll 234 racially and ethnically diverse 8th and 9th grade youth (117 intervention, 117 control), who will provide data at baseline prior to randomization, immediately post-program and 15 months post program follow-up. The aims of the study include testing the efficacy of FHF-T for high-risk 8th and 9th graders in preventing adverse outcomes and examining whether better functioning in positive youth development domains mediates intervention effects. It is hypothesized that youth randomly assigned to the FHF-T prevention condition, relative to youth assigned to the control condition, will evidence better functioning on indices of positive youth development in the REACH domains leading to better long-term outcomes, including adaptive functioning, high school graduation, career attainment/employment, healthy relationships, and quality of life.

COMPLETED
National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
Description

Trauma-informed treatment will improve emotional regulation and behavior.