Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06191653
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-12-19
Brief Title:
Mindfulness and Self-Compassion With Caregivers Working With Delinquent Youth
Sponsor:
University of Coimbra
Organization:
University of Coimbra
Study Overview
Official Title:
The Efficacy of a Mindful Self-compassion Based Program With Caregivers of Young Offenders Placed at the Portuguese Juvenile Justice Facilities
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The work carried out in Youth Detention Centers YDC represents a set of challenges for caregivers who are in the frontline of juvenile delinquency These professionals have daily to cope daily with work and relational challenges while experiencing high levels of stress and physical and emotional fatigue As such taking care of the well-being of these professionals is of paramount importance moreso as they are fundamental in the rehabilitation of young offenders Still the usual traininginterventions offered to these professionals does not considerfit to their psychological emotional or psychical difficulties Recent studies have explored the impact of contextual cognitive-behavioral interventions with caregivers eg parents of individuals with developmental disabilities nurses healthcare providers namely those based on Mindfulness and Self-Compassion The Mindfulness Self-Compassion Program MSC has been found to be effective in reducing caregivers overwhelmed feelings about their own suffering andor the suffering of others
This clinical trial intends to explore the adequacy of the adapted form of MSC 12 group sessions to caregivers working in YDC and to establish its effectiveness Two main studies will be carried out 1 a parallel non-randomized clinical trial in which the effectiveness of the program will be explored as well as the mechanisms of change of the participants responsiveness to the intervention and 2 individual interviews to assess qualitatively the participants perception about the usefulness and impact of the intervention concerning their relationship with youth and with work colleagues their relationship with themselves and the general climate of the YDC A sample of youth placed in each selected YDC will be recruited and will be assessed through self-report questionnaires at the same moments as caregivers samples It is hypothesized that the adapted form of MSC will produce significant improvements in outcome measures when comparing caregivers who receive the intervention program with those in the control group Specifically it is expected an improvement in caregivers positive feelings and well-being in their sensitivity and compassion towards others suffering as well as a decrease on some indicators of stress and suffering Consequently it is also expected that youth in YDC perceive more warmth and safeness experiences with caregivers and report increases in their interpersonal functioning
This clinical trial intends to explore the adequacy of the adapted form of MSC 12 group sessions to caregivers working in YDC and to establish its effectiveness Two main studies will be carried out 1 a parallel non-randomized clinical trial in which the effectiveness of the program will be explored as well as the mechanisms of change of the participants responsiveness to the intervention and 2 individual interviews to assess qualitatively the participants perception about the usefulness and impact of the intervention concerning their relationship with youth and with work colleagues their relationship with themselves and the general climate of the YDC A sample of youth placed in each selected YDC will be recruited and will be assessed through self-report questionnaires at the same moments as caregivers samples It is hypothesized that the adapted form of MSC will produce significant improvements in outcome measures when comparing caregivers who receive the intervention program with those in the control group Specifically it is expected an improvement in caregivers positive feelings and well-being in their sensitivity and compassion towards others suffering as well as a decrease on some indicators of stress and suffering Consequently it is also expected that youth in YDC perceive more warmth and safeness experiences with caregivers and report increases in their interpersonal functioning
Detailed Description:
Youth delinquency is a relevant social problem and there is growing interest in improving intervention with young offenders Interventions developed at the Youth Detention Centers YDC involve several human resources who daily supervise the youth routines care for them and model their behaviors The challenges and difficulties of working with people with delinquent behavior have been explored in different groups of caregivers but little studied in caregivers of young offenders Such difficulties are identified as risk factors for the development of physical and psychological symptoms in caregivers and seem to be related to personal issues eg gender age education level personal beliefs work-related motivations and levels of perceived social support but also with issues inherent to the work context characterized as challenging demanding and of great responsibility eg the ambiguity of professional role time spent in a corrective context supervision and support from hierarchical superiors job satisfaction and commitment Some authors argue that the constraints placed on caregivers significantly predict high levels of stress and compassion fatigueburnout manifested by symptoms of depression anxiety and physicalpsychological exhaustion with a negative impact on levels of compassion for others on the performance of professional duties and on the satisfaction of those who are cared for As a result of these difficulties self-care practices have been recommended in order to prevent andor relieve these symptoms in caregivers Still also in Portugal tutelaryeducative interventions are predominant with efforts being focused on the psychological rehabilitation of delinquent youth and disregarding those responsible for that rehabilitation
Recent research has evaluated the impact of contextual cognitive-behavioral interventions with groups of caregivers Interventions based on Mindfulness which aims to promote non-reactive awareness of thoughts emotions and bodily sensations and those that promote Self-compassion have stood out for their effectiveness In particular the Mindful Self-Compassion Program MSC encompasses the two previously described components and despite being less studied than approaches based solely on Mindfulness has gathered effectiveness evidence with various groups of caregivers eg nurses healthcare providers and on skills considered essential for caregivers to respond to the needs of those they care eg reduction of physicalpsychological problems increases qualitysatisfaction with life and levels of empathy and compassion towards others Recent research has shown that the MSC seems to be effective in reducing the caregivers feeling of burden with their own suffering andor with the suffering of others
Despite the importance of establishing positive and safe relationships between young offenders and their caregivers studies carried out with caregivers are scarce and focus mainly on assessing their needs andor difficulties not aiming to intervene on them Interventions offered to these caregivers aim to train them to deal with youth behavioral problems to improve their knowledge on delinquent developmental trajectories or to improve the physicalrelational settings of caregiving contexts
This work aims to fulfill this gap by studying the effectiveness of an adapted form of MSC in promoting self-care and satisfaction with life and work which are considered essential for effective care provision in caregivers of young people in Portuguese YDC This clinical trial is a parallel non-randomized controlled trial designed according to the CONSORT guidelines and carried out in 4 out of 6 YDC It aimed to test the efficacy of an adapted form of the MSC applied to caregivers working on YDC It is expected that the application of the adapted form of MSC to the YDC caregivers will contribute to an increase in caregivers physical emotional and psychological well-being and job satisfaction In addition it is also expected that the improvements mentioned above have a positive impact on the quality of the provided care and the interpersonal functioning of delinquent youth
All procedures involved in this project described elsewhere in this form were carried out according to the ethical principles of the Declaration of Helsinki and the applicable national laws and regulations Moreover all procedures were approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences University of Coimbra as well as by the Portuguese Juvenile Ministry of Justice
Informed consent will be required for all potential participants prior to any data collection Caregivers will give informed consent Adolescents aged between 14 and 16 years old YO will give informed assent while those older than 16 YO will give written informed consent A written informed consent will be gathered from guardianslegal representatives of all adolescent participants under 18 YO All participants ie caregivers and adolescents as well as their parentslegal guardians will be informed that their participation is voluntary and that they could decline to participate at any time during the project without any negative consequence Moreover participants will be informed that the confidentiality of responses would be assured at all moments The anonymity of all participants responses is guaranteed with the use of respondent-specific codes which will be also used to link the data from one time point to the other
From the 6 Portuguese YDC 4 will be selected considering the number of caregivers YDC with the highest number of staff will be selected for participation Two YDC will be allocated to the Treatment Group TG and the other two to the Control Group CG one treatment and one control group will be considered during the year of execution of this research and the other treatment and control groups will be sequentially considered in the following year after all procedures with the first groups were concluded
Caregivers in the TG will attend the adapted form of MSC for about 12 weeks The intervention consists of 12 two-hour weekly group sessions including a 10-minute coffee break delivered in each YDC to a group of 4 to 8 participants The hours spent participating in the project 24 hours will be given as time off Caregivers in the CG which functions as a waiting list control group did not receive any intervention during the study It is intended that those caregivers receive the intervention after the end of all assessment moments and at a time to be agreed with the Portuguese Juvenile Ministry of Justice Adolescents cared both by workers in the TG and CG will not receive any intervention during the study Treatment integrity will be ensured through a specific treatment manuals b direct training of the therapist and c supervision by a senior therapist with advanced training on the MSC program
Caregivers of both groups will fill out the assessment protocol individually during working hours in each YDC and the adolescents of both groups will complete the self-report questionnaires individually in the presence of the researcher responsible for the project All participants caregivers and adolescents will be assessed through self-report measures 4 times across 12 months Specifically participants will be assessed before the first session of the program baseline - time 1 right after its terminus ie post-treatment assessment - time 2 and 3 and 6 months after intervention terminus follow-up 1 and 2 - time 3 and time 4 Participants in the control group both youth and caregivers will be assessed using the same self-report instruments and with the same time intervals as those in the intervention group Quantitative analyses will be carried out according to the principle of Intention-to-treat analysis including all participants regardless of whether or not they participated in all sessions Analyses will also be carried out only with participants who completed the protocol Peer-protocol analysis Treatment effects and covariate effects will be analysed with mixed MANOVAs Change mechanism studies will be analysed with two-wave latent growth curve models
On 3 and 6-months follow-up assessments in addition to the assessment protocol caregivers of the TG will also be qualitatively evaluated through individual interviews The participants will be asked about their perception of the impact of participating in the MSC program on their relationships at the YDC namely with youth and with colleagues their perception of institutional climate their relationship with themselves and difficulties they might have felt during on using the strategies and contents learned on the MSC program This data will be analysed through thematic content and discourse analysis
Recent research has evaluated the impact of contextual cognitive-behavioral interventions with groups of caregivers Interventions based on Mindfulness which aims to promote non-reactive awareness of thoughts emotions and bodily sensations and those that promote Self-compassion have stood out for their effectiveness In particular the Mindful Self-Compassion Program MSC encompasses the two previously described components and despite being less studied than approaches based solely on Mindfulness has gathered effectiveness evidence with various groups of caregivers eg nurses healthcare providers and on skills considered essential for caregivers to respond to the needs of those they care eg reduction of physicalpsychological problems increases qualitysatisfaction with life and levels of empathy and compassion towards others Recent research has shown that the MSC seems to be effective in reducing the caregivers feeling of burden with their own suffering andor with the suffering of others
Despite the importance of establishing positive and safe relationships between young offenders and their caregivers studies carried out with caregivers are scarce and focus mainly on assessing their needs andor difficulties not aiming to intervene on them Interventions offered to these caregivers aim to train them to deal with youth behavioral problems to improve their knowledge on delinquent developmental trajectories or to improve the physicalrelational settings of caregiving contexts
This work aims to fulfill this gap by studying the effectiveness of an adapted form of MSC in promoting self-care and satisfaction with life and work which are considered essential for effective care provision in caregivers of young people in Portuguese YDC This clinical trial is a parallel non-randomized controlled trial designed according to the CONSORT guidelines and carried out in 4 out of 6 YDC It aimed to test the efficacy of an adapted form of the MSC applied to caregivers working on YDC It is expected that the application of the adapted form of MSC to the YDC caregivers will contribute to an increase in caregivers physical emotional and psychological well-being and job satisfaction In addition it is also expected that the improvements mentioned above have a positive impact on the quality of the provided care and the interpersonal functioning of delinquent youth
All procedures involved in this project described elsewhere in this form were carried out according to the ethical principles of the Declaration of Helsinki and the applicable national laws and regulations Moreover all procedures were approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences University of Coimbra as well as by the Portuguese Juvenile Ministry of Justice
Informed consent will be required for all potential participants prior to any data collection Caregivers will give informed consent Adolescents aged between 14 and 16 years old YO will give informed assent while those older than 16 YO will give written informed consent A written informed consent will be gathered from guardianslegal representatives of all adolescent participants under 18 YO All participants ie caregivers and adolescents as well as their parentslegal guardians will be informed that their participation is voluntary and that they could decline to participate at any time during the project without any negative consequence Moreover participants will be informed that the confidentiality of responses would be assured at all moments The anonymity of all participants responses is guaranteed with the use of respondent-specific codes which will be also used to link the data from one time point to the other
From the 6 Portuguese YDC 4 will be selected considering the number of caregivers YDC with the highest number of staff will be selected for participation Two YDC will be allocated to the Treatment Group TG and the other two to the Control Group CG one treatment and one control group will be considered during the year of execution of this research and the other treatment and control groups will be sequentially considered in the following year after all procedures with the first groups were concluded
Caregivers in the TG will attend the adapted form of MSC for about 12 weeks The intervention consists of 12 two-hour weekly group sessions including a 10-minute coffee break delivered in each YDC to a group of 4 to 8 participants The hours spent participating in the project 24 hours will be given as time off Caregivers in the CG which functions as a waiting list control group did not receive any intervention during the study It is intended that those caregivers receive the intervention after the end of all assessment moments and at a time to be agreed with the Portuguese Juvenile Ministry of Justice Adolescents cared both by workers in the TG and CG will not receive any intervention during the study Treatment integrity will be ensured through a specific treatment manuals b direct training of the therapist and c supervision by a senior therapist with advanced training on the MSC program
Caregivers of both groups will fill out the assessment protocol individually during working hours in each YDC and the adolescents of both groups will complete the self-report questionnaires individually in the presence of the researcher responsible for the project All participants caregivers and adolescents will be assessed through self-report measures 4 times across 12 months Specifically participants will be assessed before the first session of the program baseline - time 1 right after its terminus ie post-treatment assessment - time 2 and 3 and 6 months after intervention terminus follow-up 1 and 2 - time 3 and time 4 Participants in the control group both youth and caregivers will be assessed using the same self-report instruments and with the same time intervals as those in the intervention group Quantitative analyses will be carried out according to the principle of Intention-to-treat analysis including all participants regardless of whether or not they participated in all sessions Analyses will also be carried out only with participants who completed the protocol Peer-protocol analysis Treatment effects and covariate effects will be analysed with mixed MANOVAs Change mechanism studies will be analysed with two-wave latent growth curve models
On 3 and 6-months follow-up assessments in addition to the assessment protocol caregivers of the TG will also be qualitatively evaluated through individual interviews The participants will be asked about their perception of the impact of participating in the MSC program on their relationships at the YDC namely with youth and with colleagues their perception of institutional climate their relationship with themselves and difficulties they might have felt during on using the strategies and contents learned on the MSC program This data will be analysed through thematic content and discourse analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None