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| Name | Class |
|---|---|
| The Royal Ottawa Mental Health Centre | OTHER |
| Johns Hopkins Bloomberg School of Public Health | OTHER |
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Child sexual abuse is a large-scale global problem, and with the internet and communication technologies enabling new ways to sexually abuse children, the problem is drastically increasing.
Prevent It is a free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention for individuals concerned about their sexual urges or behaviors involving children. The treatment program is based on many years of clinical experience from working with this patient group, results from several previous research projects.
Using the scientifically rigorous design of a randomized controlled trial with waitlist control, we want to evaluate Prevent It 2.0 - an updated cognitive behavioral therapy treatment for individuals who are concerned about their sexual urges regarding children.
The study design is an academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control. Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior.
Recruitment will be carried out through multiple channels, and takes place on both "Darknet" and "Clearnet". All contact with participants, the treatment, evaluations, and termination of the contact, is conducted via the online treatment platform Iterapi, designed specifically for clinical trials of Internet-mediated CBT.
The treatment contains nine modules over thirteen weeks and the content of the therapy is classic CBT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevent It 2.0 | Experimental |
| |
| Waitlist | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevent It 2.0 | Other | A free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Is Prevent It 2.0 effective in reducing participants' urges to act on sexual behaviors involving children, as measured by the SSAS (Sexual Symptom Assessment Scale)?involving children | Sexual Symptom Assessment Scale, The range is 0 to 48, with 0 indicating no symptoms and 48 indicating severe symptoms. | Up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Is Prevent It 2.0 effective in reducing participants' sexual behaviors involving children, as measured by the Sexual Child Molestation Risk Assessment (the SChiMRA+) Part B? | The Sexual Child Molestation Risk Assessment, there's no scoring system at the moment. It's all item-by-item. But for all items, higher values are worse (e.g., more hours watching CSAM, more motivation to interact with children, etc). |
| Measure | Description | Time Frame |
|---|---|---|
| Is Prevent It 2 safe from a negative side effects perspective, as measured by the Negative Effects Questionnaire (NEQ-20)? | NEQ-20 taps the occurrence (binary, yes or no) and severity (on a 5-point Likert scale 0-4, ranging from not at all to extremely) of 20 statements regarding negative effects of psychological treatment and ends with one free-text question. For each statement answered with yes , the respondent also reports whether they believe the negative effect is caused by "the treatment I received" or "other circumstances". Maximum score = 80, Minimum score = 0. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoffer Rahm, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPF - centrum för psykiatriforskning. | Stockholm | 113 64 | Sweden |
Individual participant data that underlie the results reported in each respective article, after deidentification (text, tables, figures and appendices). Fully deidentified participant data will be shared in a public repository without demographic information. Data with demographic information will be shared with an approved data access agreement.
For data shared through a data access agreement, beginning 3 months and ending 5 years following each article publication. Data shared in a public repository will be available immediately following each article publication and will be available for at least 5 years.
For data that contain demographic information, investigators who provide a methodologically sound proposal, and whose proposed use of the data has been approved by an independent review committee identified for this purpose. Any researcher may access the version of the data available in a public repository.
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| ID | Term |
|---|---|
| D010378 | Pedophilia |
| ID | Term |
|---|---|
| D010262 | Paraphilic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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An academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control
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| Waitlist | Other | Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior. |
|
| Up to 13 weeks |
| Up to 13 weeks |
| Comparisons of attrition rates in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1? | Up to 13 weeks |
| Comparisons of SChiMRA in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1? | Up to 13 weeks |
| Comparisons of NEQ-20 in active arm and waitlist in Prevent It 2, to active arm and placebo in Prevent It 1? | Up to 13 weeks |