Abuse PreventionAP4IDNCT03998605
Protect Yourself: Abuse Prevention for People With Intellectual Disabilities
A study testing Abuse Prevention Program in people with Abuse Prevention, run by Double S Instructonal Systems at 1 site in United States.
Trial summary
The purpose of this study is to help individuals and their caregivers develop a plan on how to recognize, deal with and respond to abusive situations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abuse Prevention
- What is being tested?
- Abuse Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- has moderate to mild mental retardation based on IQ scores ranging from 40-70
- is over 18 years old. --the participant must be able to do three of the following four skills (1) complete a simple worksheet with assistance, (2) go on simple errands alone, (3) recognize 10 or more words by site, (4) read a digital clock.
Who cannot join
- individuals who have experienced traumatic abuse and experiences symptoms suggestive of trauma, such as flashbacks, nightmares, and chronic anxiety and/or depression that is resistant to standard pharmacological and psychotherapy/behavior interventions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Double S Instructional Systems
Eugene, Oregon, 97405
About this study
The purpose of this study is to help individuals and their caregivers develop a plan on how to recognize, deal with and respond to abusive situations.
Read the detailed description
The goal of this project is to address the current deficiencies by creating a program that will guide individuals who have intellectual disabilities and a Learning Partner (LP - care provider, relative, group home staff) in developing a comprehensive Individual Response Plan (IRP) that can be used before, during, and after an abusive event. Behavioral skills training and behavioral relaxation training -- two instructional approaches with evidence for effectiveness in this population -- will be included to address the unique learning needs of people who have intellectual disabilities and to maximize opportunities for skill-based learning. Video and workbook activities will train the LP to effectively implement the abuse prevention and response strategies, thus increasing the potential for generalization in the natural environment and long-term maintenance of skills.
- Conditions
- Abuse Prevention
- Being tested
- Abuse Prevention Program, Control Condition
- Keywords
- intellectual disabilities, abuse, abuse prevention
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abuse Prevention ProgramBehavioural
The abuse prevention program will be comprised of nine shared learning modules for the individual with Intellectual Disabilities (ID) and a care provider. Each shared module will contain an action step in the Individual Response Plan and will include video, guided practice and workbook activities to equip persons with ID with a range of judgment, decision-making skills and the efficacy needed for identifying, rejecting, and reporting abuse.
Control ConditionBehavioural
The control group will receive worksheets from the ESCAPE-NOW curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Abuse Prevention Program Condition | Experimental | The abuse prevention program will address: (1) BEFORE -- (a) Learning about problem of abuse and what abuse is; (b) Knowing about types of abuse, who the abusers are and where abuse happens; (c) Planning ahead and identifying safe people; (2) DURING -- (a) Rejecting abuse by saying "no;" (b) Getting away if possible/staying safe and paying attention, (c) Staying calm and getting home; and (3) AFTER -- (a) Telling your safe person, (b) Knowing what to do and what not to do, and (c) Reporting the abuse and getting help to cope with the event. Receives: Behavioral: Abuse Prevention Program |
| Control condition | Active comparator | During the study the control group will receive 12 activity sheets from the ESCAPE-NOW curriculum. Six activity sheets will be given at the initial meeting and half way through the study the remaining activity sheets will be mailed to the dyads. We chose these activity sheets because they provide abuse information that was designed for individuals with ID. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abuse Protection Concept Questionnaire
This questionnaire assesses change in knowledge and attitude about various types of abuse in individuals with Intellectual Disability (ID). The questionnaire includes three sub scales. The first sub-scale is comprised of five open ended questions. Score answers range from 0 to 3 with a total score of 15. Higher scores reflect higher knowledge. The second sub-scale presents structured questions about the five types of abuse. The total possible score for the first part of the second sub-scale is 5 -- with higher score reflecting greater knowledge. Participants are then shown five pictures depicting types of abuse. Each correct response was awarded a point for a total of five. The total possible score for sub-sale 2 is 10. Sub-scale 3 is a 20 item forced choice -- yes (1) , no (0), don't know (0) - that assesses knowledge and attitudes. with a total possible sub-score of 20 -- higher score equals higher knowledge.
Measured: Pre, post (9 weeks), and 2 month follow-up
Abuse Protection Decision Making and Task Analysis Check Sheet
This checklist assesses change in knowledge required by people with ID to recognize and report abuse. It consists of five vignettes of abusive situations and two non-abusive. Each vignette has a a possible score of 10. The total possible score for all seven vignettes is 70 with higher scores reflecting greater knowledge.
Measured: Pre, post (9 weeks), and 2 month follow-up
Secondary outcomes (3)
Glascow Social Self-Efficacy Scale
Change in social self-efficacy in people with moderate to mild intellectual disabilities as measured by the 17-item self-efficacy scale. A three point response format is used to answer each question: not at all, a little bit, or a lot. Responses are scored 0,1, and 2 respectively giving a range of 0-34. Higher values represent better outcomes.
Measured: Pre, post (9 weeks), and 2 month follow-up
Test of Interpersonal Competence and Personal Vulnerability
Change in the 20-item multiple-choice interpersonal competence and vulnerability of individuals with ID. Each question has three answers with only one best answer for each question.Scoring is from 0 to 1 with 1 being the best answer. Scores range from 0 to 20 with higher scores showing improvement in interpersonal competence and personal vulnerability.
Measured: Pre, post (9 weeks), and 2 month follow-up
Social Vulnerability Questionnaire
Change in social vulnerability in individuals with ID as measured by 45 items that assess social vulnerability. Care provider rates individual with ID on a 4-point Likert scale (1=not true or never to 4= very true or always). Scores range from 45 to 180. Lower scores reflect improvements in social vulnerability.
Measured: Pre, post (9 weeks), and 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start4 Oct 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: no release of remaining funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse PreventionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Double S Instructonal Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Martin R. Sheehan, Ph.D., Principal investigator, Research Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998605
- Sponsor's protocol ID
- AbusePhaseII
- Other IDs
- R44HD079119-02
- Acronym
- AP4ID
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2019
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protect Yourself: Abuse Prevention for People With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT03998605
- Acronym / sponsor ID
- AP4ID / AbusePhaseII
- Conditions
- Abuse Prevention
- Keywords
- intellectual disabilities, abuse, abuse prevention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no release of remaining funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Double S Instructonal SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 4 Oct 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Jun 2019 (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.
The purpose of this study is to help individuals and their caregivers develop a plan on how to recognize, deal with and respond to abusive situations.
Detailed description
The goal of this project is to address the current deficiencies by creating a program that will guide individuals who have intellectual disabilities and a Learning Partner (LP - care provider, relative, group home staff) in developing a comprehensive Individual Response Plan (IRP) that can be used before, during, and after an abusive event. Behavioral skills training and behavioral relaxation training -- two instructional approaches with evidence for effectiveness in this population -- will be included to address the unique learning needs of people who have intellectual disabilities and to maximize opportunities for skill-based learning. Video and workbook activities will train the LP to effectively implement the abuse prevention and response strategies, thus increasing the potential for generalization in the natural environment and long-term maintenance of skills.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abuse Prevention Program Condition | Experimental | Behavioral: Abuse Prevention ProgramThe abuse prevention program will address: (1) BEFORE -- (a) Learning about problem of abuse and what abuse is; (b) Knowing about types of abuse, who the abusers are and where abuse happens; (c) Planning ahead and identifying safe people; (2) DURING -- (a) Rejecting abuse by saying "no;" (b) Getting away if possible/staying safe and paying attention, (c) Staying calm and getting home; and (3) AFTER -- (a) Telling your safe person, (b) Knowing what to do and what not to do, and (c) Reporting the abuse and getting help to cope with the event. |
| Control condition | Active comparator | Behavioral: Control ConditionDuring the study the control group will receive 12 activity sheets from the ESCAPE-NOW curriculum. Six activity sheets will be given at the initial meeting and half way through the study the remaining activity sheets will be mailed to the dyads. We chose these activity sheets because they provide abuse information that was designed for individuals with ID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- has moderate to mild mental retardation based on IQ scores ranging from 40-70
- is over 18 years old. --the participant must be able to do three of the following four skills (1) complete a simple worksheet with assistance, (2) go on simple errands alone, (3) recognize 10 or more words by site, (4) read a digital clock.
Key exclusion criteria (1 listed)
- individuals who have experienced traumatic abuse and experiences symptoms suggestive of trauma, such as flashbacks, nightmares, and chronic anxiety and/or depression that is resistant to standard pharmacological and psychotherapy/behavior interventions.
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 |
|---|---|---|
| Abuse Prevention ProgramThe abuse prevention program will be comprised of nine shared learning modules for the individual with Intellectual Disabilities (ID) and a care provider. Each shared module will contain an action step in the Individual Response Plan and will include video, guided practice and workbook activities to equip persons with ID with a range of judgment, decision-making skills and the efficacy needed for identifying, rejecting, and reporting abuse. | Behavioural | Abuse Prevention Program Condition |
| Control ConditionThe control group will receive worksheets from the ESCAPE-NOW curriculum. | Behavioural | Control condition |
Primary outcome
Abuse Protection Concept Questionnaire
Time frame: Pre, post (9 weeks), and 2 month follow-up
This questionnaire assesses change in knowledge and attitude about various types of abuse in individuals with Intellectual Disability (ID). The questionnaire includes three sub scales. The first sub-scale is comprised of five open ended questions. Score answers range from 0 to 3 with a total score of 15. Higher scores reflect higher knowledge. The second sub-scale presents structured questions about the five types of abuse. The total possible score for the first part of the second sub-scale is 5 -- with higher score reflecting greater knowledge. Participants are then shown five pictures depicting types of abuse. Each correct response was awarded a point for a total of five. The total possible score for sub-sale 2 is 10. Sub-scale 3 is a 20 item forced choice -- yes (1) , no (0), don't know (0) - that assesses knowledge and attitudes. with a total possible sub-score of 20 -- higher score equals higher knowledge.
Abuse Protection Decision Making and Task Analysis Check Sheet
Time frame: Pre, post (9 weeks), and 2 month follow-up
This checklist assesses change in knowledge required by people with ID to recognize and report abuse. It consists of five vignettes of abusive situations and two non-abusive. Each vignette has a a possible score of 10. The total possible score for all seven vignettes is 70 with higher scores reflecting greater knowledge.
3 secondary outcomes
Glascow Social Self-Efficacy Scale
Time frame: Pre, post (9 weeks), and 2 month follow-up
Test of Interpersonal Competence and Personal Vulnerability
Time frame: Pre, post (9 weeks), and 2 month follow-up
Social Vulnerability Questionnaire
Time frame: Pre, post (9 weeks), and 2 month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Martin R. Sheehan, Ph.D. principal investigator
Research Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abuse Prevention Program in people with Abuse Prevention, run by Double S Instructonal Systems 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 15 Feb 2023. 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 withdrawn before enrolling participants, so there are no results.
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?
Abuse Protection Concept Questionnaire (time frame: Pre, post (9 weeks), and 2 month follow-up). 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 15 Feb 2023.