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临床试验/NCT04386681
NCT04386681进行中(未招募)不适用

Re-entry Continuum for Brain Injury

Rehabilitation Hospital of Indiana2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
102
试验地点
2
主要终点
Change in Survey of Unmet Needs and Services Utilized (SUNSU)

研究概览

简要总结

The overall research objectives of the proposed project are to decrease the rate of recidivism, defined as returning to incarceration within three years of release, as well as reduce the number of violent offenses, through the successful implementation of a continuum of services that addresses the unique needs of the TBI population. RHI, in partnership with PCF and IU, will work together to accomplish these goals. To meet study objectives, this randomized controlled trial (RCT) will enroll 102 individuals with TBI who will be randomized into the Reentry Continuum for Brain Injury (RCBI) intervention or a TAU-CG. Participants will be screened for TBI eight months prior to release from PCF. Upon consenting to participate, all subjects will be evaluated before, during, and after the intervention and recidivism data will be collected through IDOC's Data Analysis and Technology Department.

详细描述

Specific aims of the current proposal are as follows:

Aim 1. To examine differences in recidivism [return to incarceration within 3 years] in participant offenders with TBI who are reentering the community and are either randomized to RCBI or TAU-CG.

Hypothesis 1 (H1): Participants in the RCBI group will demonstrate a lower proportion of recidivating participants than the TAU-CG one year, two years, and three years post release.

Aim 2. To examine differences in violent offenses [number of pre-release violent behavioral infractions; number of post-release felonies committed and their classifications] in participant offenders with TBI who are reentering the community and are either randomized to RCBI or TAU-CG during 3 months pre-release, and one, two, and three years post-release.

Hypothesis 2A (H2A): Participants in the RCBI group will demonstrate lower rates of in-prison violent behavioral infractions between enrollment and release than participants in the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • History of moderate to severe TBI
  • Ages 18 and older
  • Offenders currently serving their sentence at PCF in Greencastle, Indiana
  • Approximately twelve or less months remaining in their sentence, but no fewer than 5 months remaining in sentence.

排除标准

  • In restricted housing (e.g., solitary confinement)
  • Inability to comprehend the study
  • Individuals requiring a legally authorized representative (LAR)

结局指标

主要结局

Change in Survey of Unmet Needs and Services Utilized (SUNSU)

时间窗: 3 months, 1 year

This measure is designed to assess both the usage of and desire for services unique to brain injury. The SUNSU includes a comprehensive list of 27 service needs and results in two scores: the number of met needs and the number of unmet needs. The measure shows good internal consistency as well as validity when compared to other needs assessments in the brain injury population. Participants decide if they : currently want help for the need, currently receiving help for the need, or it is not a need at all.

Change in Recidivism

时间窗: 1 year after release, 2 years after release, 3 years after release

This is defined as return to incarceration within three years of release and is the primary outcome to be collected through the IDOC Research and Technology Division for all participants at three time points: one, two, and three years after release.

Change in Behavioral Infractions

时间窗: 3 months

This is collected from PCF directly for each participant at time of release. The number and type of infractions will be counted between study enrollment and release.

Change in Employment

时间窗: Prior to release, 1 year after release, 2 years after release, and 3 years after release

This includes acquisition and sustainability (i.e., duration of employment) data will be collected through the IDOC Research and Technology Division for all offenders at three time points: one year, two years, and three years after release from IDOC.

Change in Violent Rearrests

时间窗: 1 year after release, 2 years after release, 3 years after release

This is collected for each participant through the IDOC Data Analysis and Technology Department for all offenders at three time points: one year, two years, and three years after release from IDOC. Offenses are coded between 1 and 6 with 1 being the highest level of violence and 6 being the lowest level/non-violent. Type of offense in criminal history (violent vs. nonviolent) will also be collected as a covariate.

Change in Attributions of Intent Hostility Questionnaire (AIHQ)

时间窗: within 2 weeks, 3 months

This consists of 5 written vignettes describing ambiguous actions/ situations (unclear intent behind actions). After participants read each vignette and imagine the scenario happening to her or him, they are asked five questions: 1) why the other person (or persons) acted that way toward you (open-ended response later rated by an independent rater; score indicates ''hostility bias''); 2) Whether the other person (or persons) performed the action on purpose (1 ''definitely no'' to 6 ''definitely yes'') using a Likert Scale (Intent score); 3) how angry it would make them feel (1 ''not at all angry'' to 5 ''very angry'') using a Likert scale (anger score); 4) how much they would blame the other person (or persons) (1 ''not at all'' to 5 ''very much'') using a Likert scale (blame score); and 5) how she or he would respond to the situation, (open-ended response).

Change in Participation Assessment with Combined Tools - Objective (PART-O)

时间窗: 3 months, 1 year

This is a 17-item measure developed and validated by the NIDILRR-sponsored TBI Model Systems13 to evaluate participation in the community with three domains: Productivity, Social Relations, and Out and About. Each item is scored on a 0 to 5 scale. Total PART-O scores will be used for our analyses.

Change in Brain Injury Coping Skills Questionnaire (BICS-Q)

时间窗: within 2 weeks, 3 months

Designed to measure self-efficacy related to brain injury. BICS-Q was designed based on Bandura's Guide for developing self-efficacy scales. Participants rate 20 items using a 5-point Likert-scale resulting in a total score. BICS-Q has shown significant change across BICS participants in multiple studies. Participants rate each statement from 0 (Not at all) to 4 (Extremely). Higher scores suggest greater self-efficacy.

Change in Brain Injury Coping Skills Questionnaire (BICS-Q)

时间窗: within 2 weeks, 3 months

Designed to measure self-efficacy related to brain injury. BICS-Q was designed based on Bandura's Guide for developing self-efficacy scales. Participants rate 20 items using a 5-point Likert-scale resulting in a total score. BICS-Q has shown significant change across BICS participants in multiple studies. Participants rate each statement from 0 (Not at all) to 4 (Extremely). Higher scores suggest greater self-efficacy.

Change in Aggression Questionnaire (AQ)

时间窗: within 2 weeks, 3 months

A standardized measure comprised of 34 statements to assess anger, hostile thoughts, and physical and verbal aggression.10 Participants rate statements using a 5-point scale (1 - Extremely uncharacteristic of me to 5 - Extremely characteristic of me). Raw and scaled scores (adjusted by age and gender) are provided for aggression subcomponents and total aggression. Total aggression will be used for our analyses. The AQ is a widely used measure, including for TBI studies.11 It has good test-retest reliability (.72-.80), and good internal consistency (.76-.94). Higher scores suggest higher aggression tendencies

Change in Attributions of Intent Hostility Questionnaire (AIHQ)

时间窗: within 2 weeks, 3 months

This consists of 5 written vignettes describing ambiguous actions/ situations (unclear intent behind actions). After participants read each vignette and imagine the scenario happening to her or him, they are asked five questions: 1) why the other person (or persons) acted that way toward you (open-ended response later rated by an independent rater; score indicates ''hostility bias''); 2) Whether the other person (or persons) performed the action on purpose (1 ''definitely no'' to 6 ''definitely yes'') using a Likert Scale (Intent score); 3) how angry it would make them feel (1 ''not at all angry'' to 5 ''very angry'') using a Likert scale (anger score); 4) how much they would blame the other person (or persons) (1 ''not at all'' to 5 ''very much'') using a Likert scale (blame score); and 5) how she or he would respond to the situation, (open-ended response).

Change in Participation Assessment with Combined Tools - Objective (PART-O)

时间窗: 3 months, 1 year

This is a 17-item measure developed and validated by the NIDILRR-sponsored TBI Model Systems13 to evaluate participation in the community with three domains: Productivity, Social Relations, and Out and About. Each item is scored on a 0 to 5 scale. Total PART-O scores will be used for our analyses.

Change in Survey of Unmet Needs and Services Utilized (SUNSU)

时间窗: 3 months, 1 year

This measure is designed to assess both the usage of and desire for services unique to brain injury. The SUNSU includes a comprehensive list of 27 service needs and results in two scores: the number of met needs and the number of unmet needs. The measure shows good internal consistency as well as validity when compared to other needs assessments in the brain injury population. Participants decide if they : currently want help for the need, currently receiving help for the need, or it is not a need at all.

Change in Recidivism

时间窗: 1 year after release, 2 years after release, 3 years after release

This is defined as return to incarceration within three years of release and is the primary outcome to be collected through the IDOC Research and Technology Division for all participants at three time points: one, two, and three years after release.

Change in Behavioral Infractions

时间窗: 3 months

This is collected from PCF directly for each participant at time of release. The number and type of infractions will be counted between study enrollment and release.

Change in Employment

时间窗: Prior to release, 1 year after release, 2 years after release, and 3 years after release

This includes acquisition and sustainability (i.e., duration of employment) data will be collected through the IDOC Research and Technology Division for all offenders at three time points: one year, two years, and three years after release from IDOC.

Change in Violent Rearrests

时间窗: 1 year after release, 2 years after release, 3 years after release

This is collected for each participant through the IDOC Data Analysis and Technology Department for all offenders at three time points: one year, two years, and three years after release from IDOC. Offenses are coded between 1 and 6 with 1 being the highest level of violence and 6 being the lowest level/non-violent. Type of offense in criminal history (violent vs. nonviolent) will also be collected as a covariate.

次要结局

  • Change in Behavioral Rating Inventory of Executive Function-Adult Version (BRIEF-A)(within 2 weeks, 3 months, 1 year)
  • Level of Service Inventory - Revised (LSI-R)(within 2 weeks)

研究者

发起方
Rehabilitation Hospital of Indiana
申办方类型
Other
责任方
Principal Investigator
主要研究者

Devan Parrott

Director of the Research Training and Outcome Center

Rehabilitation Hospital of Indiana

研究点 (2)

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