Trauma, SexualNCT04902287
PHF Problematic Sexual Behavior of Youth Family Engagement
A study testing Training Intervention for the Engagement of Families (TIES) in people with Trauma, Sexual, run by University of Oklahoma at 1 site in United States.
Trial summary
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 appointment. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Sexual
- What is being tested?
- Training Intervention for the Engagement of Families (TIES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2021to 18 Feb 2022
- Phase
- Interventional
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
CCAN Cares Clinic/OU Child Study Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: From Science to Practice: An Evidence Based Engagement Intervention to Support Treatment Success for Youth's Problematic Sexual Behavior
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 appointment. Fortunately, interventions have been developed to increase the likelihood that families will participate in treatment. Despite the development of these interventions, no research to date has evaluated these strategies with a critically important population, youth with problematic sexual behaviors (PSB). PSBs in children are a substantial public health concern, as greater than one-third of child sexual abuse cases are committed by other youth. Evidence based practices (EBP's) that include direct engagement of caregivers in services for youth PSB have strong efficacy, with recidivism rates of two percent. Thus, a therapeutic response that successfully engages families is necessary to promote community safety. Research has indicated that engagement of families in PSB treatment has greater complications due to managing internal and external experiences of shame, stigma, and misperceptions of youth. Therefore, the present study seeks to determine the impact of a first contact intervention to assess if strategies aid in the 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. This project is the first step in an innovative line of research that will provide practical strategies for practitioners to utilize in order to successfully recruit, retain, and heal families of youth with PSB.
Read the 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.
- Conditions
- Trauma, Sexual
- Being tested
- Training Intervention for the Engagement of Families (TIES)
- Medical subject headings
- Sexual Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training Intervention for the Engagement of Families (TIES)Behavioural
This intervention involves training service personnel in a method of communication that elicits a person's intrinsic motivation for change.
| Study group | Role | What they receive |
|---|---|---|
| TIES Engagement Strategies | Experimental | Participants in this arm will receive a 30-minute TIES engagement intervention during their referral phone call. Receives: Behavioral: Training Intervention for the Engagement of Families (TIES) |
| Referral as Usual | No intervention | Participants in this arm will receive a standard call to schedule an intake appointment by an administrative assistant with no clinical training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance in Treatment
Completed number of treatment sessions
Measured: 18 weeks
Provider Rated Engagement
Measure completed weekly from the lead therapist regarding each family's participation in the treatment session
Measured: 18 weeks
Secondary outcomes (2)
Client Satisfaction Questionnaire (CSQ-8)
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.
Measured: 18 weeks
Working Alliance Inventory (WAI-SR; WAI-CA)
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.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start13 Oct 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Why it stopped: Funding ending due to PI leaving position at the University of Oklahoma.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, SexualStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The current clinical trial involves two conditions (N=20 each): engagement condition or referral as usual
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer D Shields, PHD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902287
- Sponsor's protocol ID
- 20211217
- Status last verified
- May 2022
- First submitted
- 21 May 2021
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Science to Practice: An Evidence Based Engagement Intervention to Support Treatment Success for Youth's Problematic Sexual Behavior
- ClinicalTrials.gov ID
- NCT04902287
- Acronym / sponsor ID
- 20211217
- Conditions
- Trauma, Sexual
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ending due to PI leaving position at the University of Oklahoma.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 26 May 2021 (actual)
- 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.
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 appointment. Fortunately, interventions have been developed to increase the likelihood that families will participate in treatment. Despite the development of these interventions, no research to date has evaluated these strategies with a critically important population, youth with problematic sexual behaviors (PSB). PSBs in children are a substantial public health concern, as greater than one-third of child sexual abuse cases are committed by other youth. Evidence based practices (EBP's) that include direct engagement of caregivers in services for youth PSB have strong efficacy, with recidivism rates of two percent. Thus, a therapeutic response that successfully engages families is necessary to promote community safety. Research has indicated that engagement of families in PSB treatment has greater complications due to managing internal and external experiences of shame, stigma, and misperceptions of youth. Therefore, the present study seeks to determine the impact of a first contact intervention to assess if strategies aid in the 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. This project is the first step in an innovative line of research that will provide practical strategies for practitioners to utilize in order to successfully recruit, retain, and heal families of youth with PSB.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The current clinical trial involves two conditions (N=20 each): engagement condition or referral as usual
| Arm | Type | Receives |
|---|---|---|
| TIES Engagement Strategies | Experimental | Behavioral: Training Intervention for the Engagement of Families (TIES)Participants in this arm will receive a 30-minute TIES engagement intervention during their referral phone call. |
| Referral as Usual | No intervention | –Participants in this arm will receive a standard call to schedule an intake appointment by an administrative assistant with no clinical training. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Training Intervention for the Engagement of Families (TIES)This intervention involves training service personnel in a method of communication that elicits a person's intrinsic motivation for change. | Behavioural | TIES Engagement Strategies |
Primary outcome
Attendance in Treatment
Time frame: 18 weeks
Completed number of treatment sessions
Provider Rated Engagement
Time frame: 18 weeks
Measure completed weekly from the lead therapist regarding each family's participation in the treatment session
2 secondary outcomes
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 18 weeks
Working Alliance Inventory (WAI-SR; WAI-CA)
Time frame: 18 weeks
Results and safety
The study was stopped early (reason given: Funding ending due to PI leaving position at the University of Oklahoma.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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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.
Jennifer D Shields, PHD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Intervention for the Engagement of Families (TIES) in people with Trauma, Sexual, run by University of Oklahoma 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 26 May 2022. 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.
Are results available for this study?
The study was stopped early (reason given: Funding ending due to PI leaving position at the University of Oklahoma.). Results are not available in the source record.
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?
Attendance in Treatment (time frame: 18 weeks). The study lists 2 primary outcomes in all. 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 26 May 2022.