Clinical trial NCT04162977: Adapting Personality-Targeted Interventions for Reducing Substance Misuse and Related Outcomes in Youth in Youth Protection Services
Official title: Well-Venture Pilot Project: Adapting Personality-Targeted Interventions for Reducing Substance Misuse and Related Outcomes in Youth in Youth Protection Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Youth Protection Services
Early Intervention
Prevention
Adolescent Development
Keywords: Substance Use and Misuse
Prevention
Early Intervention
Mental Health
Complex Trauma
Youth Protection Services.
Adolescence
Personality-targeted Interventions
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Batshaw Youth and Family Centres
First posted: 2019-11-14
Enrollment: 62
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study examines the feasibility and proof-of-concept of implementing personality-targeted interventions for high-risk adolescents receiving services from Youth Protection Services. For testing the feasibility, this study compares the following outcomes with the same outcomes from previous Preventure trials with community samples: facilitator's score on Intervention/implementation fidelity, number of high-risk youth who agree to participate in intervention sessions, and elements of youth's feedback. For testing the proof-of-concept, this study examines effects of interventions on change in substance use outcomes, depression symptoms, and self-reported anxiety sensitivity and impulsivity at 3- and 6-month post-intervention. Previous trials with the community samples indicated that these primary outcomes largely accounted for the long-term intervention effects on reduction of substance use outcomes.
Primary purpose: PREVENTION

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 (i.e., 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) (i.e., 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 (i.e., Preventure programme) for high-risk adolescents receiving services from Youth Protection Services.The 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 (i.e., 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) (i.e., 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 (i.e., 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 youth's 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: facilitator's score on Intervention/implementation fidelity, number of high-risk youth who agree to participate in the intervention sessions, and elements of youth's feedback (assessment immediately at the end of second intervention session). Preventure Intervention/implementation 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 (i.e., 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 adversity/maltreatment, 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 (i.e., 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 facilitator's score on Intervention/implementation fidelity scale, number of high-risk youth who agree to participate in the interventions, and elements of youth's 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.

Eligibility criteria: Inclusion Criteria:

• Receiving services from Batshaw Youth and Family Centres under the Youth Protection Services

Exclusion Criteria:

* Severe cognitive impairments
* Acute psychotic symptoms

Primary outcomes:
measure: Rate of Depression Symptoms
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Self-reported Anxiety Sensitivity
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Feasibility Outcome 1: Score on Preventure Intervention/implementation Fidelity Scale
timeFrame: Baseline during two intervention sessions
measure: Feasibility Outcome 2: Number of high-risk youth who agree to participate in the intervention sessions
timeFrame: Baseline
measure: Feasibility Outcome 3: Youth-generated feedback
timeFrame: Baseline (directly post-intervention)
measure: Rate of Binge Drinking
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Total Number of Drug Used
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Rate of Alcohol-related Harm
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Self-reported Impulsivity
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Rate of Drug-related Harm
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
Secondary outcomes:
measure: Rate of Anxiety Symptoms
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Emotion Dysregulation
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Self-esteem Score
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Rate of Conduct Problems
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Rate of Hyperactivity/inattentive Problems
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Rate of Post-traumatic Stress Disorder Symptoms
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
measure: Rate of Complex-Post-traumatic Stress Disorder Symptoms
timeFrame: Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Batshaw Youth and Family Centres
state: Quebec
Study officials:
affiliation: St-Justine Hospital, University of Montreal
name: Hanie Edalati, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St-Justine Hospital, University of Montreal
name: Patricia J Conrod, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edalati H, Conrod PJ. A Review of Personality-Targeted Interventions for Prevention of Substance Misuse and Related Harm in Community Samples of Adolescents. Front Psychiatry. 2019 Jan 22;9:770. doi: 10.3389/fpsyt.2018.00770. eCollection 2018.
citation: Edalati H, Conrod PJ. A review to identify gaps in research and service delivery for substance use prevention among at-risk adolescents involved in child welfare system: the promises of targeted interventions. International Journal of Child and Adolescent Resilience (2017) 5:20-39.
citation: Woicik PA, Stewart SH, Pihl RO, Conrod PJ. The Substance Use Risk Profile Scale: a scale measuring traits linked to reinforcement-specific substance use profiles. Addict Behav. 2009 Dec;34(12):1042-55. doi: 10.1016/j.addbeh.2009.07.001. Epub 2009 Jul 8.
citation: Conrod PJ. Personality-Targeted Interventions for Substance Use and Misuse. Curr Addict Rep. 2016;3(4):426-436. doi: 10.1007/s40429-016-0127-6. Epub 2016 Nov 4.