UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035822 |
|---|---|
| Receipt number | R000040811 |
| Scientific Title | Efficacy of prison-based cognitive behavioural rehabilitation intervention on violent sexual behaviours among sex offenders in Nigerian prisons |
| Date of disclosure of the study information | 2019/02/09 |
| Last modified on | 2019/02/08 23:38:34 |
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Basic information
Public title
Efficacy of prison-based cognitive behavioural rehabilitation intervention on violent sexual behaviours among sex offenders in Nigerian prisons
Acronym
Prison-based cognitive behavioural rehabilitation intervention for violent sexual behaviours
Scientific Title
Efficacy of prison-based cognitive behavioural rehabilitation intervention on violent sexual behaviours among sex offenders in Nigerian prisons
Scientific Title:Acronym
Prison-based cognitive behavioural rehabilitation intervention for violent sexual behaviours
Region
| Africa |
Condition
Condition
Violent sexual behaviours
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examined the efficacy of prison-based cognitive behavioural rehabilitation intervention on violent sexual behaviours among sex offenders in Nigerian prisons.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Compulsive Sexual Behavior Inventory (CSBI-22)=Time1, Time2 and Time3
Hypersexual Behavior Inventory (HBI)=Time1, Time2 and Time3
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Prison-based cognitive behavioural rehabilitation intervention (PCBRI) Group lasted for16 weeks, one session per week.
Interventions/Control_2
No Intervention Group lasted for16 weeks, one session per week
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 21 | years-old | < |
Age-upper limit
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
Participants were considered for inclusion following the classification criteria of the Diagnostic Statistical Mental Manual-V (DSM-V) of compulsive sexual disorder. In addition, for a violent sex offender to participate in this study, the following factors was critically considered namely sex offenders that are convicted/awaiting trial staying correctional setting, readiness to receive treatment, high-risk level as in DSM-V.
Key exclusion criteria
Participants that did not qualify for the criteria were excluded.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Bonaventure N. Nwokeoma |
Organization
University of Nigeria
Division name
Department of Sociology and Anthropology
Zip code
Address
Department of Sociology and Anthropology, Faculty of Social Sciences, University of Nigeria, Nsukka, Enugu State
TEL
+2348037089645
bonaventure.nwokeoma@unn.edu.ng
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Moses Onyemaechi Ede |
Organization
University of Nigeria, Nsukka
Division name
Department of Educational Foundations
Zip code
Address
Department of Educational Foundations Faculty of Education, University of Nigeria, Nsukka, Nigeria.
TEL
+2347066725165
Homepage URL
moses.ede@unn.edu.ng
Sponsor or person
Institute
Otusum
Institute
Department
Personal name
Funding Source
Organization
University of Nigeria
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This study showed that the effect of prison-based cognitive behavioural rehabilitation intervention was significant on violent sexual behaviours among sex offenders in Nigerian prisons as measured by HBI and CSBI. This present study also found the coping rates among sex offender with violent sexual behaviours were significantly decreased in favour of participants in treatment group at Time 2 and Time 3.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 14 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 17 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040811
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
