- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04902287
PHF Problematic Sexual Behavior of Youth Family Engagement
From Science to Practice: An Evidence Based Engagement Intervention to Support Treatment Success for Youth's Problematic Sexual Behavior
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Efficacious child mental health services are only helpful if families engage in services. However, as many as 75% of families in need never establish contact with a mental health professional and greater than half of families fail to attend their first scheduled visit. Fortunately, first contact interventions have reduced barriers and increased the likelihood that a family begin services following initial referral. Research has demonstrated the effectiveness of a phone intervention using 'Training Intervention for the Engagement of Families' (TIES) for engagement of families referred to outpatient behavioral health services due to childhood trauma and disruptive behavior disorders. However, engagement intervention strategies have not yet been applied to a critically important population, youth with problematic sexual behaviors (PSB), who face unique barriers to engagement in treatment. PSBs in children are a substantial public health concern, as greater than one-third of child sexual abuse cases have been found to be committed by other youth. Evidence based practices (EBP's) that include direct engagement of caregivers in services for children with PSB have strong efficacy, with recidivism rates of two percent. Thus, a therapeutic response is most logical to promote community safety and prevent future incidence of PSB. Despite the development of efficacious treatment, EBP's are not provided to most youth with PSB. Our research has indicated that engagement of families when a child has PSB has greater complications due to managing internal and external experiences of shame, stigma, and misperceptions surrounding the youth's behaviors, as well as navigation of a large number of systems (e.g., child welfare, juvenile justice, law enforcement). Given the potential negative impact of treatment attrition on overall community safety and child well-being, research efforts concentrated on identifying strategies that enhance service engagement for the treatment of youth with PSB are warranted. While TIES strategies have shown great promise in increasing family engagement, no research to date has examined the impact of purposeful, evidence-based engagement intervention on decreasing attrition amongst families of youth with PSB. A critical gap exists in the research literature, as families of youth with PSB face additional perceptual barriers to engaging in treatment such as a hesitancy to discuss stigmatizing behaviors due to feelings of responsibility and shame. Therefore, the present study seeks to determine the impact of this intervention to assess if these strategies successfully aid in both the successful engagement of families in treatment for youth PSB as compared to referral as usual. This will be accomplished by conducting a small-scale Randomized Control Trial (RCT). We will test the hypothesis that TIES engagement strategies will improve both initial and sustained engagement in EBP as compared to referral as usual amongst families of school aged children with PSB. The proposed study will accomplish this through the following specific aims:
Aim 1. To examine the efficacy of an evidence-based engagement intervention strategy for successfully engaging families of youth with PSB in treatment. Families' who are referred to the PSB-CBT treatment services will be randomly assigned to TIES strategies or referral as usual procedures to test the impact of an evidence-based engagement intervention on program attrition. Factors such as parenting stress, child emotional and behavioral health concerns, treatment satisfaction and alliance will be examined to understand their unique contribution to family attrition in treatment for this population.
Aim 2. In order to accomplish Aim 1, we will first systematically adapt the TIES intervention to meet the unique needs of families of youth with PSB to improve the ability of TIES to decrease overall attrition. Adaptations to TIES strategies will include supporting families to overcome barriers such as navigating community systems and addressing misperceptions such as shame and stigma of youth with PSB.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73117
- CCAN Cares Clinic/OU Child Study Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Child between the ages of 7-12 who is referred to the treatment program for youth with PSB
- At least one incident of developmentally inappropriate sexual behavior
- Speak and understand English
Exclusion Criteria:
- Court mandate to participate in treatment
- Anticipation of a change of placement within three months
- Have a current diagnosis of a developmental disorder, schizophrenia, bipolar disorder, or intellectual disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TIES Engagement Strategies
Participants in this arm will receive a 30-minute TIES engagement intervention during their referral phone call.
|
This intervention involves training service personnel in a method of communication that elicits a person's intrinsic motivation for change.
|
|
No Intervention: Referral as Usual
Participants in this arm will receive a standard call to schedule an intake appointment by an administrative assistant with no clinical training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance in Treatment
Time Frame: 18 weeks
|
Completed number of treatment sessions
|
18 weeks
|
|
Provider Rated Engagement
Time Frame: 18 weeks
|
Measure completed weekly from the lead therapist regarding each family's participation in the treatment session
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 18 weeks
|
The CSQ-8 is an 8-item reliable and valid outcome measure that assesses for client satisfaction with treatment services.
The CSQ-8 has no subscales and reports a single score measuring a single dimension of overall satisfaction with treatment.
Higher scores indicate a stronger level of satisfaction.
|
18 weeks
|
|
Working Alliance Inventory (WAI-SR; WAI-CA)
Time Frame: 18 weeks
|
Treatment alliance between the therapist and family will be measured using the Working Alliance Inventory - Short Revised (WAI-SR) and Working Alliance Inventory - Children and Adolescents (WAI-CA).
The WAI-SR and WAI-CA assesses the therapeutic alliance between a child and their caregiver with the therapeutic provider.
This form will be completed by both caregiver and child at 1-month and discharge.
Both the WAI-SR and WAI-CA have demonstrated high levels of internal consistency and external validity.
Higher scores represent a higher level of treatment alliance.
|
18 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer D Shields, PHD, University of Oklahoma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20211217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma, Sexual
-
VA Office of Research and DevelopmentNot yet recruitingSexual TraumaUnited States
-
Iowa City Veterans Affairs Medical CenterUnited States Department of Defense; US Department of Veterans AffairsCompletedPTSD | TBI | Military Physical and Sexual Trauma | Combat TraumaUnited States
-
Sykehuset TelemarkUniversity of Agder; NTNU Health (sponsor)RecruitingSexual Trauma | Sexual Abuse | Posttraumatic Stress SymptomNorway
-
Sykehuset TelemarkUniversity of Agder; NTNU Health (sponsor)Not yet recruitingPosttraumatic Stress Symptoms | Sexual Trauma | Sexual AbuseNorway
-
Vanderbilt University Medical CenterWithdrawnSexual Dysfunction | Upper Extremity Trauma
-
Sykehuset TelemarkUniversity of Agder; NTNU Health (sponsor)Active, not recruitingSexual Trauma | Sexual Abuse | Partner | Posttraumatic Stress SymptomNorway
-
Duke UniversityNational Institutes of Health (NIH); Durham VA Medical CenterCompletedStress Disorder, Post Traumatic | Military Sexual TraumaUnited States
-
Weill Medical College of Cornell UniversityUnited States Department of DefenseRecruiting
-
Columbia UniversityNational Institute of Mental Health (NIMH); University of Cape TownActive, not recruitingHIV | Trauma ExposureSouth Africa
-
Seattle Institute for Biomedical and Clinical ResearchUnited States Department of DefenseActive, not recruitingPost Traumatic Stress Disorder | Military Sexual Trauma (MST)United States
Clinical Trials on Training Intervention for the Engagement of Families (TIES)
-
Allison GibsonCompleted
-
Double S Instructonal SystemsWithdrawnParent-Child Relations
-
University of Bari Aldo MoroUniversity of Roma La SapienzaNot yet recruitingFamily Conflict | Family Characteristics | Family Dysfunctional
-
National Yang Ming Chiao Tung UniversityCompleted
-
Umm Al-Qura UniversityCompleted
-
Direction Centrale du Service de Santé des ArméesAssociation Francaise de ChirurgieCompletedTrauma Injury | Surgical Procedure, Unspecified | War InjuryFrance
-
University of Wisconsin, MadisonCompleted
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedDementia | Alzheimer DiseaseUnited States
-
Université de SherbrookeCanadian Institutes of Health Research (CIHR)Recruiting