Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04162977
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2019-08-19
Brief Title:
Adapting Personality-Targeted Interventions for Reducing Substance Misuse and Related Outcomes in Youth in Youth Protection Services
Sponsor:
St Justines Hospital
Organization:
St Justines Hospital
Study Overview
Official Title:
Well-Venture Pilot Project Adapting Personality-Targeted Interventions for Reducing Substance Misuse and Related Outcomes in Youth in Youth Protection Services
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Substance use problems are major concern in adolescents involved in Youth Protection Services However there is an enormous gap between the needs and availability of interventions for youth with substance use problems in the system The present study will examine the feasibility and proof-of-concept of implementing an evidence-based personality-targeted drug and alcohol prevention programme for high-risk adolescents ie Preventure programme receiving services from Youth Protection Services Our goal is to examine the effects of these interventions on reducing rates of substance use outcomes depression symptoms and self-reported anxiety sensitivity and impulsivity at 3- and 6-month post-intervention These primary outcomes were selected based on previous Preventure trials with the community samples that indicated these factors largely accounted for the long-term intervention effects on improving substance use outcomes The study will be conducted at Batshaw Youth and Family Centres which provide psychosocial rehabilitation and social integration services and services related to child placement and adoption to English-speaking youth from all regions of Quebec Adolescents receiving services from Batshaw centres N 100 aged 14 and above will be invited to participate in the study All interested adolescents will be invited to attend one assessment session with the research team Participants who score high on one of subscales of Substance Use Risk Profile Scale SURPS ie high-risk adolescents will be invited to participate in two 90-minute group-based intervention sessions which target their dominant personality profile Sessions will be cognitive-behavioural in nature and are designed to help youth understand the target personality trait and develop adaptive coping strategies for managing that trait using motivational and cognitive restructuring techniques The primary outcomes will be measured at baseline before receiving the interventions and then with 3-month and 6-month intervals after receiving the interventions to test whether these outcomes are significantly reduced after receiving the interventions The results of this study will be used to plan the future directions of personality-targeted interventions for youth involved in Youth Protection Services
Detailed Description:
Background and aims
Substance use problems are major concern in adolescents involved in Youth Protection Services Some studies estimated that 1 in 5 adolescents involved in Youth Protection Services struggle with a substance use problem In addition living in foster homes increases the likelihood of substance abuse by five times compared to no history of removal Investigators of this study have conducted a review to identify the gaps in research and service delivery for substance use prevention and early interventions among at-risk adolescents involved in Youth Protection Services This review showed that there is an enormous gap between the needs and availability of interventions for youth with substance use problems with less than 10 of these adolescents and young adults receive such interventions This article also reviewed the evidence that showed targeting personality risk profiles is potentially a good strategy for reducing substance use problems and increasing resilience in this population
The present study examines the feasibility and proof-of-concept of implementing an evidence-based personality-targeted drug and alcohol prevention programme ie Preventure programme for high-risk adolescents receiving services from Youth Protection ServicesThe Preventure programme is a selective substance use prevention programme designed to target known personality risk factors for substance misuse based on the evidence from cross-sectional and longitudinal studies which connect these personality risk factors to early initiation and escalation of substance misuse in adolescents This selected personality-targeted approach targets four personality-specific motivational pathways to substance misuse Hopelessness Negative Thinking Anxiety Sensitivity Impulsivity and Sensation Seeking
The study is conducted at Batshaw Youth and Family Centres which provide psychosocial rehabilitation and social integration services and services related to child placement and adoption to English-speaking youth from all regions of Quebec
A working group consisting of research scientists in the fields of adolescent mental health childhood trauma and substance use prevention and the coordinator of the residential and rehabilitation program of Batshaw Centres met on February 11 2019 to discuss details of the pilot trial required changes to the content of personality-targeted interventions ie Preventure Programme and the study timeline
Study Design
Participants All adolescents receiving services from the Batshaw Centres starting October 2nd 2019 are invited to participate in this study Batshaw Centres provide services to an average of 100 adolescents aged 14 and above during every 6-month period This study aims to recruit all interested adolescents aged 14 and above for this pilot project
Recruitment Consent Staff at Batshaw Centres will give a brief description including basic information about the study to all adolescents in their units Interested participants will be invited for the pre-intervention screening Passive consent from parents or legal guardians is required Prior to starting the study an information letter will be provided to all parents notifying them that the study is taking place at Batshaw Centres and explaining the study and interventions They will be asked to sign and return the letter if they do not agree to their child participating in this study An assent form will be provided to adolescents and thoroughly explained by the Batshaw staff and research investigator Adolescents are required to sign the assent form prior starting the study
Procedure Adolescents who score high on one of the Substance Use Risk Profile Scale SURPS ie high-risk individuals will be invited to participate in brief group-based intervention sessions which target their dominant personality profile The criterion for high scores on SURPS personality traits ie high-risk are determined based on norms from high-risk adolescents in the same age range who participated in previous trials of personality-targeted interventions Intervention sessions will be delivered by trained educators or counsellors from Batshaw According to the literature it is estimated that around 80 of recruited youth N 80 will show high scores in one of the personality risk profiles The rest of participants N 20 low-risk adolescents will receive the treatment as usual Adolescents receive an honorarium of 30 in the form of gift card upon completion of each assessments for a total of 90
Screening Both groups of participants will be followed for 6 months Screening will take place using a computerized program installed on laptops provided by the research team The screening is completed at baseline and then 3-month and 6-month intervals after receiving the interventions and takes 50-60 minutes The screening procedure includes several questionnaires and computerized tasks which have been validated by the scientific community These questionnaires involve assessing youths personality traits cognitive functioning substance use outcomes and psychiatric symptoms The research investigator will be present during the assessment sessions to ready the participants and materials give instructions expla study goals and procedure answer questions and supervise the session
Outcome Measures All participants will be assessed by the same measures 3 and 6 months after receiving the interventions
For testing the feasibility this study will compare the following outcomes with the same outcomes from the previous successful trials with the community samples facilitators score on Interventionimplementation fidelity number of high-risk youth who agree to participate in the intervention sessions and elements of youths feedback assessment immediately at the end of second intervention session Preventure Interventionimplementation Fidelity Scale PIFA was designed by the Preventure team to measure the level of implementation of the programme and facilitators adherence and fidelity to the critical ingredients of the Preventure programme This measure has been used in previous trials of Preventure programme with the community samples Group Experience Questionnaire was also designed by the Preventure team to measure youth-generated perspectives and feedback on the intervention Our previous studies using this questionnaire have shown that youth perspectives on the intervention independently accounted for up to 12-25 of the variance in changes in alcohol consumption and mental health symptoms over 12 months These findings highlight the positive youth experiences of the programme as a significant indicator of its efficacy
For the proof-of-concept this study will examine the rates of depression symptoms self-reported anxiety sensitivity and impulsivity and several substance use outcomes at baseline and then 3-month and 6-month intervals after receiving the interventions and test whether these outcomes are significantly reduced after receiving the interventions These primary outcomes ie early mechanisms of change were selected based on previous Preventure trials with the community samples that indicated these factors largely accounted for the long-term intervention effects on improving substance use outcomes According to our conversation with the Batshaw centres around 60 of the adolescents in their care suffer from some forms of substance use problems Therefore reductions in substance use problems is regarded as a significant indicator of the proof-of-concept in this study
Additional information on research participants The rates of childhood adversitymaltreatment involvement in criminal justice system low academic performance and psychiatric diagnoses are particularly high in this population which may influence the results of the study In addition the exact date of the admission and type of other interventions received before and during this trial are needed to be considered in the analyses Participants files will be used to gain this information A protocol was designed and approved by the Research Ethics Board to access participants files
Interventions All interventions will be conducted at Batshaw centres by a trained facilitator and a co-facilitator After selection on personality scale ie SURPS high-risk adolescents will be invited to participate in brief group-based intervention sessions which target their dominant personality profile Hopelessness Anxiety Sensitivity Impulsivity or Sensation Seeking Each intervention will involve two 90-minute sessions with an average of 4-6 personality-matched adolescents per group and will be conducted using manuals that incorporate psycho-educational motivational enhancement therapy MET and cognitive behavioural therapy CBT components which include real life scenarios shared by high-risk youth from Montreal with similar personality profiles
Analyses Correlation analyses will be used to examine the patterns of substance use and related mental health problem in relation to personality profiles of adolescents in Youth Protection Services For the feasibility analyses t-test will be used to compare results of facilitators score on Interventionimplementation fidelity scale number of high-risk youth who agree to participate in the interventions and elements of youths feedback with results from previous trials which were successful in reducing rates of substance use outcomes among community samples For proof-of-concept analyses a repeated measure ANCOVA will be used to examine the change in pre- and post-intervention assessments of substance use outcomes depression symptoms and scores of anxiety sensitivity and impulsivity while controlling for the effects of confounding variables such as histories of childhood maltreatment and socio-economic status This study will also conduct some secondary data analyses with other outcomes such as cognitive functioning and psychiatric symptoms to guide future directions
Follow-up survey After completing the intervention sessions some of youth who received personality-targeted interventions and group facilitators will be invited to participate in separate focus groups with the research team to comment on various aspects of their experiences of interventions using a qualitative method This qualitative data and the quantitative data from the pre- and post-intervention assessments will be discussed in the second working group to plan the future directions for personality-targeted interventions for youth involved in Youth Protection Services
Substance use problems are major concern in adolescents involved in Youth Protection Services Some studies estimated that 1 in 5 adolescents involved in Youth Protection Services struggle with a substance use problem In addition living in foster homes increases the likelihood of substance abuse by five times compared to no history of removal Investigators of this study have conducted a review to identify the gaps in research and service delivery for substance use prevention and early interventions among at-risk adolescents involved in Youth Protection Services This review showed that there is an enormous gap between the needs and availability of interventions for youth with substance use problems with less than 10 of these adolescents and young adults receive such interventions This article also reviewed the evidence that showed targeting personality risk profiles is potentially a good strategy for reducing substance use problems and increasing resilience in this population
The present study examines the feasibility and proof-of-concept of implementing an evidence-based personality-targeted drug and alcohol prevention programme ie Preventure programme for high-risk adolescents receiving services from Youth Protection ServicesThe Preventure programme is a selective substance use prevention programme designed to target known personality risk factors for substance misuse based on the evidence from cross-sectional and longitudinal studies which connect these personality risk factors to early initiation and escalation of substance misuse in adolescents This selected personality-targeted approach targets four personality-specific motivational pathways to substance misuse Hopelessness Negative Thinking Anxiety Sensitivity Impulsivity and Sensation Seeking
The study is conducted at Batshaw Youth and Family Centres which provide psychosocial rehabilitation and social integration services and services related to child placement and adoption to English-speaking youth from all regions of Quebec
A working group consisting of research scientists in the fields of adolescent mental health childhood trauma and substance use prevention and the coordinator of the residential and rehabilitation program of Batshaw Centres met on February 11 2019 to discuss details of the pilot trial required changes to the content of personality-targeted interventions ie Preventure Programme and the study timeline
Study Design
Participants All adolescents receiving services from the Batshaw Centres starting October 2nd 2019 are invited to participate in this study Batshaw Centres provide services to an average of 100 adolescents aged 14 and above during every 6-month period This study aims to recruit all interested adolescents aged 14 and above for this pilot project
Recruitment Consent Staff at Batshaw Centres will give a brief description including basic information about the study to all adolescents in their units Interested participants will be invited for the pre-intervention screening Passive consent from parents or legal guardians is required Prior to starting the study an information letter will be provided to all parents notifying them that the study is taking place at Batshaw Centres and explaining the study and interventions They will be asked to sign and return the letter if they do not agree to their child participating in this study An assent form will be provided to adolescents and thoroughly explained by the Batshaw staff and research investigator Adolescents are required to sign the assent form prior starting the study
Procedure Adolescents who score high on one of the Substance Use Risk Profile Scale SURPS ie high-risk individuals will be invited to participate in brief group-based intervention sessions which target their dominant personality profile The criterion for high scores on SURPS personality traits ie high-risk are determined based on norms from high-risk adolescents in the same age range who participated in previous trials of personality-targeted interventions Intervention sessions will be delivered by trained educators or counsellors from Batshaw According to the literature it is estimated that around 80 of recruited youth N 80 will show high scores in one of the personality risk profiles The rest of participants N 20 low-risk adolescents will receive the treatment as usual Adolescents receive an honorarium of 30 in the form of gift card upon completion of each assessments for a total of 90
Screening Both groups of participants will be followed for 6 months Screening will take place using a computerized program installed on laptops provided by the research team The screening is completed at baseline and then 3-month and 6-month intervals after receiving the interventions and takes 50-60 minutes The screening procedure includes several questionnaires and computerized tasks which have been validated by the scientific community These questionnaires involve assessing youths personality traits cognitive functioning substance use outcomes and psychiatric symptoms The research investigator will be present during the assessment sessions to ready the participants and materials give instructions expla study goals and procedure answer questions and supervise the session
Outcome Measures All participants will be assessed by the same measures 3 and 6 months after receiving the interventions
For testing the feasibility this study will compare the following outcomes with the same outcomes from the previous successful trials with the community samples facilitators score on Interventionimplementation fidelity number of high-risk youth who agree to participate in the intervention sessions and elements of youths feedback assessment immediately at the end of second intervention session Preventure Interventionimplementation Fidelity Scale PIFA was designed by the Preventure team to measure the level of implementation of the programme and facilitators adherence and fidelity to the critical ingredients of the Preventure programme This measure has been used in previous trials of Preventure programme with the community samples Group Experience Questionnaire was also designed by the Preventure team to measure youth-generated perspectives and feedback on the intervention Our previous studies using this questionnaire have shown that youth perspectives on the intervention independently accounted for up to 12-25 of the variance in changes in alcohol consumption and mental health symptoms over 12 months These findings highlight the positive youth experiences of the programme as a significant indicator of its efficacy
For the proof-of-concept this study will examine the rates of depression symptoms self-reported anxiety sensitivity and impulsivity and several substance use outcomes at baseline and then 3-month and 6-month intervals after receiving the interventions and test whether these outcomes are significantly reduced after receiving the interventions These primary outcomes ie early mechanisms of change were selected based on previous Preventure trials with the community samples that indicated these factors largely accounted for the long-term intervention effects on improving substance use outcomes According to our conversation with the Batshaw centres around 60 of the adolescents in their care suffer from some forms of substance use problems Therefore reductions in substance use problems is regarded as a significant indicator of the proof-of-concept in this study
Additional information on research participants The rates of childhood adversitymaltreatment involvement in criminal justice system low academic performance and psychiatric diagnoses are particularly high in this population which may influence the results of the study In addition the exact date of the admission and type of other interventions received before and during this trial are needed to be considered in the analyses Participants files will be used to gain this information A protocol was designed and approved by the Research Ethics Board to access participants files
Interventions All interventions will be conducted at Batshaw centres by a trained facilitator and a co-facilitator After selection on personality scale ie SURPS high-risk adolescents will be invited to participate in brief group-based intervention sessions which target their dominant personality profile Hopelessness Anxiety Sensitivity Impulsivity or Sensation Seeking Each intervention will involve two 90-minute sessions with an average of 4-6 personality-matched adolescents per group and will be conducted using manuals that incorporate psycho-educational motivational enhancement therapy MET and cognitive behavioural therapy CBT components which include real life scenarios shared by high-risk youth from Montreal with similar personality profiles
Analyses Correlation analyses will be used to examine the patterns of substance use and related mental health problem in relation to personality profiles of adolescents in Youth Protection Services For the feasibility analyses t-test will be used to compare results of facilitators score on Interventionimplementation fidelity scale number of high-risk youth who agree to participate in the interventions and elements of youths feedback with results from previous trials which were successful in reducing rates of substance use outcomes among community samples For proof-of-concept analyses a repeated measure ANCOVA will be used to examine the change in pre- and post-intervention assessments of substance use outcomes depression symptoms and scores of anxiety sensitivity and impulsivity while controlling for the effects of confounding variables such as histories of childhood maltreatment and socio-economic status This study will also conduct some secondary data analyses with other outcomes such as cognitive functioning and psychiatric symptoms to guide future directions
Follow-up survey After completing the intervention sessions some of youth who received personality-targeted interventions and group facilitators will be invited to participate in separate focus groups with the research team to comment on various aspects of their experiences of interventions using a qualitative method This qualitative data and the quantitative data from the pre- and post-intervention assessments will be discussed in the second working group to plan the future directions for personality-targeted interventions for youth involved in Youth Protection Services
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