- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07516080
Feasibility Trial of a Correctional Management for Juvenile Offenders
The goal of this clinical trial is to learn if a structured Correctional Management intervention can be feasibly implemented with incarcerated juveniles in a correctional institution. It will also assess whether the research procedures can be successfully carried out with this population.
The main questions it aims to answer are:
- Can participants be effectively recruited, retained, and engaged, and can the intervention be delivered acceptably with adequate therapist adherence and complete outcome data collection?
- Does the intervention demonstrate preliminary effectiveness? Researcher will compare an experimental (intervention) group to a control group receiving standard institutional management to see if the intervention can be practically delivered and is associated with initial changes in outcomes.
Participants will:
- Be randomly assigned to either the intervention group or the control group
- Complete assessments at baseline (before the intervention) and post-intervention
- Attend structured intervention sessions (if assigned to the experimental group)
- Complete standardized self-report measures assessing emotional and behavioral difficulties, psychological capital, criminal thinking styles, attitudes toward seeking mental health services, emotion regulation, and moral disengagement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a parallel-group randomized feasibility trial designed to evaluate the practicality of implementing a structured Correctional Management Plan for juvenile offenders residing in a correctional institutional setting. The study will recruit a total of 30 participants, who will be randomly assigned in a 1:1 ratio to either an experimental intervention group or a control group receiving routine institutional management.
The primary objective of the trial is to assess the feasibility of implementing the intervention. The primary outcomes of this feasibility study include recruitment feasibility, retention/completion rate, participant adherence, intervention fidelity, and intervention acceptability.
Secondary exploratory objectives include estimating preliminary effects of the intervention on psychological and behavioral outcomes relevant to juvenile rehabilitation. These outcomes will be measured using standardized self-report instruments administered at two time points: baseline (pre-intervention) and immediately following completion of the intervention (post-intervention).
Participants assigned to the experimental group will receive a structured Correctional Management Plan consisting of 15 group-based sessions delivered twice a week, with each session lasting approximately 90 to 120 minutes. The intervention will be delivered by a qualified psychologist and will span approximately 7-8 weeks. The program follows a structured protocol incorporating cognitive-behavioral strategies, emotion regulation training, moral reasoning exercises, identity development components, and future orientation planning. Sessions include structured discussions, guided reflection, skill rehearsal, and behavioral accountability activities within a therapeutic group setting.
Participants assigned to the control group will continue to receive standard institutional management and routine services provided by the correctional facility during the study period. Eligible participants will be identified through institutional records.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shahmeen Noor
- Phone Number: +923336963847
- Email: shahmeennoor44@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- District Jail, Lahore
-
Contact:
- Principal Investigator
- Phone Number: +923336963847
- Email: shahmeennoor44@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male juvenile offenders aged 11 to 17 years
- Currently residing in a correctional institution
- Able to understand Urdu and participate in group-based sessions
- Provide informed assent
Exclusion Criteria:
- Presence of a severe psychiatric condition requiring immediate or intensive clinical treatment
- Significant cognitive impairment or developmental condition that limits ability to engage in the intervention
- Currently receiving another structured psychological or behavioral intervention
- Medical or behavioral condition that would interfere with safe participation, as determined by institutional staff or the researcher
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Correctional Management for Juvenile Offenders
Participants assigned to this arm will receive a structured Correctional Management Plan delivered in a group format over approximately 7-8 weeks.
The intervention consists of 15 sessions conducted twice weekly, with each session lasting 90-120 minutes.
The program is delivered by a trained psychologist and follows a structured manual incorporating cognitive-behavioral techniques, emotion regulation training, moral reasoning, identity development, and future planning.
Sessions include guided discussions, skill-building exercises, behavioral activities, and reflective tasks aimed at improving psychological and behavioral functioning among juvenile offenders.
|
Juveniles often face a range of psychological, emotional, and behavioral difficulties that contribute to their engagement in harmful or delinquent behaviors such as theft, physical fights, property offenses, and in some cases more serious acts including violent or sexual offenses and drug-related activities. Many struggle with impulsivity, difficulty in regulating their emotions, moral disengagement, and difficulties in understanding the consequences of their actions. This structured therapeutic intervention aims to support psychological rehabilitation of incarcerated juveniles through 15 group-based sessions. The program targets emotional awareness, emotion regulation, cognitive restructuring, accountability, empathy, understanding consequences of behavior, consent awareness, identity development, relapse prevention, and future planning to promote reintegration. |
|
No Intervention: Standard Institutional Management (Control)
Participants assigned to this arm will continue to receive standard institutional management and routine services provided by the correctional facility during the study period.
No structured psychological intervention or additional therapeutic program will be introduced as part of the study.
Participants will complete baseline and post-intervention assessments at the same time points as the experimental group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Rate
Time Frame: From baseline to post-intervention (approximately 7-8 weeks)
|
Recruitment rate will be defined as the proportion of eligible participants who provide informed consent to participate in the study.
This will be calculated during the recruitment phase at baseline and reported as a percentage, reflecting the feasibility of enrolling participants into the intervention.
|
From baseline to post-intervention (approximately 7-8 weeks)
|
|
Retention Rate
Time Frame: From baseline to post-intervention (approximately 7-8 weeks)
|
Retention rate will be defined as the proportion of participants who remain in the study and complete the post-intervention assessment.
This outcome will be assessed from baseline to post-intervention (approximately 7-8 weeks) and reported as a percentage, indicating the ability to maintain participant involvement over time.
|
From baseline to post-intervention (approximately 7-8 weeks)
|
|
Participant Adherence
Time Frame: From baseline to post-intervention (approximately 7-8 weeks)
|
Participant adherence will be measured by session attendance, calculated as the number of sessions attended out of a total of 15 sessions.
This may also be expressed as a percentage and will be assessed across the intervention period (7-8 weeks), providing an indication of participant engagement with the program.
|
From baseline to post-intervention (approximately 7-8 weeks)
|
|
Intervention Fidelity
Time Frame: From baseline to post-intervention (approximately 7-8 weeks)
|
Intervention fidelity will be evaluated using a structured fidelity checklist to assess the extent to which the intervention is delivered in accordance with the established protocol.
Fidelity scores will be reported as a percentage, reflecting the consistency and quality of intervention delivery throughout the study period
|
From baseline to post-intervention (approximately 7-8 weeks)
|
|
Acceptability of the Intervention
Time Frame: From baseline to post-intervention (approximately 7-8 weeks)
|
Acceptability will be assessed at post-intervention using the Acceptability of Intervention Measure, a 4-item self-report scale rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree), yielding a total score range of 4 to 20.
Higher scores indicate greater perceived acceptability of the intervention.
|
From baseline to post-intervention (approximately 7-8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Emotional and Behavioral Difficulties (SDQ)
Time Frame: From baseline to post-intervention (approximately 7-8 weeks)
|
Assessed using the Strengths and Difficulties Questionnaire (SDQ), a 25-item self-report measure of emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior.
Total Difficulties scores range from 0 to 40, with higher scores indicating greater emotional and behavioral problems.
|
From baseline to post-intervention (approximately 7-8 weeks)
|
|
Change from Baseline in Psychological Capital (APS)
Time Frame: From baseline to post-intervention (approximately 7-8 weeks)
|
Psychological capital will be assessed using the Anila Psychological Capital Scale, a 34-item self-report measure assessing resilience, hope, self-efficacy, and optimism.
Each item is rated on a Likert scale, with total scores ranging from 34 to 170.
Higher scores indicate greater psychological capital (i.e., a better outcome).
Change from baseline will be evaluated from pre-intervention to post-intervention (approximately 7-8 weeks).
|
From baseline to post-intervention (approximately 7-8 weeks)
|
|
Change from Baseline in Criminal Thinking Styles (JCTSI)
Time Frame: From baseline to post-intervention (approximately 7-8 weeks)
|
Criminal thinking styles will be assessed using the Juvenile Criminal Thinking Styles Inventory, a 52-item self-report measure comprising three subscales: Juvenile Social Alienation Scale (18 items), Juvenile Vindication Scale (19 items), and Juvenile Domination Scale (15 items).
All items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Subscale scores range from 18 to 90 for social alienation, 19 to 95 for vindication, and 15 to 75 for domination, while the total score ranges from 52 to 260.
Higher scores indicate greater levels of maladaptive criminal thinking (i.e., a worse outcome).
Change from baseline will be assessed from pre-intervention to post-intervention (approximately 7-8 weeks).
|
From baseline to post-intervention (approximately 7-8 weeks)
|
|
Change from Baseline in Emotion Regulation (ERQ)
Time Frame: From baseline to post-intervention (approximately 7-8 weeks)
|
Emotion regulation will be assessed using the Emotion Regulation Questionnaire, a 10-item self-report measure comprising two independent subscales: Cognitive Reappraisal (6 items) and Expressive Suppression (4 items).
Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree).
Subscale scores are calculated separately, with Cognitive Reappraisal scores ranging from 6 to 42 and Expressive Suppression scores ranging from 4 to 28.
Higher scores on Cognitive Reappraisal indicate greater use of adaptive emotion regulation (i.e., a better outcome), whereas higher scores on Expressive Suppression indicate greater use of a less adaptive strategy (i.e., a worse outcome).
Change from baseline will be evaluated from pre-intervention to post-intervention (approximately 7-8 weeks).
|
From baseline to post-intervention (approximately 7-8 weeks)
|
|
Change from Baseline in Moral Disengagement (MDSA)
Time Frame: From baseline to post-intervention (approximately 7-8 weeks)
|
Moral disengagement will be assessed using the Moral Disengagement Scale for Adolescents, a 24-item self-report measure designed to assess cognitive mechanisms used to justify harmful behavior among adolescents.
Items are rated on a 5-point Likert scale with response options ranging from "Not at all agree" to "Always agree," yielding a total score range of 24 to 120.
Higher scores indicate greater levels of moral disengagement (i.e., a worse outcome).
Change from baseline will be assessed from pre-intervention to post-intervention (approximately 7-8 weeks).
|
From baseline to post-intervention (approximately 7-8 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- No. D/28/FIMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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