NCT04162977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 2, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

August 19, 2019

Last Update Submit

October 22, 2020

Conditions

Keywords

Substance Use and MisusePreventionEarly InterventionMental HealthComplex TraumaYouth Protection Services.AdolescencePersonality-targeted Interventions

Outcome Measures

Primary Outcomes (10)

  • Rate of Depression Symptoms

    Change in the rate of depression symptoms is assessed using depression subscale of Brief Symptom Inventory. The depression subscale includes six items each rated on a five-point scale (0 = not at all, 1 = a little bit, 2 = moderately, 3 = quite a bit, 4 = often). Responses are summed to create a total score ranging from 0 to 24. Higher scores indicate higher rates of depression symptoms.

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • Self-reported Anxiety Sensitivity

    Change in the score of personality trait of anxiety sensitivity is assessed using anxiety sensitivity subscale of Substance Use Risk Profile Scale. Substance Use Risk Profile Scale assesses the variability on the four personality risk factors for substance misuse and dependence. Anxiety sensitivity subscale includes 5 items rated on a 4 point scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Responses are summed to create a total score ranging from 5 to 20. Higher scores indicate more elevation on personality trait of anxiety sensitivity.

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • Feasibility Outcome 1: Score on Preventure Intervention/implementation Fidelity Scale

    Facilitator's score on Preventure Intervention/implementation Fidelity Scale (PIFA) rated by session supervisor: Preventure Intervention/implementation Fidelity Scale (PIFA) evaluates adherence to 12 core treatment components of the personality-targeted intervention program (e.g., goal setting, identifying and challenging automatic thoughts). This scale will be used during supervision in order to provide trainees with feedback and ensure that they reached sufficient levels of program delivery.

    Baseline during two intervention sessions

  • Feasibility Outcome 2: Number of high-risk youth who agree to participate in the intervention sessions

    Number of high-risk youths who agree to participate in the intervention sessions.

    Baseline

  • Feasibility Outcome 3: Youth-generated feedback

    Percentage of youth reporting positive group experiences, learning and skill development: Participants will complete a brief feedback questionnaire regarding their intervention experiences directly following the final intervention session. This questionnaire includes 22 questions asking about their experiences of participating in the workshops rated on a 4-point scale ranging from Strongly Disagree to Strongly Agree. Participants will also respond to 4 open-ended questions in free format namely "Something that you liked about the group", "Something that you didn't like the group", "What is the most important thing you have learned from this workshop?" and "What is the change that you are considering?" Finally they will respond to questions relating to their level of motivation and self-efficacy to make a personal change using a 7-point Likert scale (0 = not at all motivated/confident, 7 = extremely motivated/confident).

    Baseline (directly post-intervention)

  • Rate of Binge Drinking

    Change in the rate of binge drinking is assessed by an item from the 'Detection of alcohol and drug problems in adolescents' questionnaire (DEP-ADO). Binge drinking is assessed by asking youth to indicate how often they consumed five or more standard alcoholic drinks on the same occasion during the last 12 months (at baseline) or 3 months (at 3- and 6-month post-intervention assessments). Higher numbers indicate higher rate of binge drinking.

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • Total Number of Drug Used

    Change in the total number of drug used is assessed by items from the 'Detection of alcohol and drug problems in adolescents' questionnaire (DEP-ADO). Youth are first asked to indicate if they have used one or more of the listed substances (e.g., Cannabis, Cocaine, Heroin, Opiates) and if so, to indicate how often they had consumed each in the past 12 months (at baseline) or 3 months (at 3- and 6-month post-intervention assessments) on a six-point scale (0 = never to 5 = every day). Higher scores indicate higher number of drug used.

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • Rate of Alcohol-related Harm

    Change in the rate of alcohol-related harm is assessed by items from the 'Detection of alcohol and drug problems in adolescents' questionnaire (DEP-ADO). As participants are encouraged to discuss their substance use problem as part of the intervention, the item from the original measure asked 'if they discussed their alcohol use with a counsellor in the last 12 months' will be removed from the analysis. Youth are asked to indicate if they have experienced any of the 9 listed problematic situations because of alcohol in the past 12 months (at baseline) or 3 months (at 3- and 6-month post-intervention assessments). Responses are rated as 1 = Yes and 0 = No and summed to create a total score ranging from 0 to 9. Higher scores indicate higher rates of alcohol-related harm.

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • Self-reported Impulsivity

    Change in the score of personality trait of impulsivity is assessed using impulsivity subscale of Substance Use Risk Profile Scale. Substance Use Risk Profile Scale assesses the variability on the four personality risk factors for substance misuse and dependence. Impulsivity subscale includes 5 items rated on a 4 point scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Responses are summed to create a total score ranging from 5 to 20. Higher scores indicate more elevation on personality trait of impulsivity.

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • Rate of Drug-related Harm

    Change in the rate of drug-related harm is assessed by items from the modified version of 'Detection of alcohol and drug problems in adolescents' questionnaire (DEP-ADO). As participants are encouraged to discuss their substance use problem as part of the intervention, the item from the original measure asked 'if they discussed their drug use with a counsellor in the last 12 months' will be removed from the analysis. Youth are asked to indicate if they have experienced any of the 9 listed problematic situations because of drugs in the past 12 months (at baseline) or 3 months (at 3- and 6-month post-intervention assessments). Responses are rated as 1 = Yes and 0 = No and summed to create a total score ranging from 0 to 9. Higher scores indicate higher rates of drug-related harm.

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

Secondary Outcomes (7)

  • Rate of Anxiety Symptoms

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • Emotion Dysregulation

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • Self-esteem Score

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • Rate of Conduct Problems

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • Rate of Hyperactivity/inattentive Problems

    Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention

  • +2 more secondary outcomes

Study Arms (1)

High-risk youth

EXPERIMENTAL

The 23-item Substance Use Risk Profile Scale (SURPS) will be used to identify high-risk adolescents who enter the intervention trial. Adolescents who score high on one of SURPS subscales (i.e., high-risk youth) will be invited to participate in two group-based intervention sessions which target their dominant personality profile. The criterion for high scores on SURPS personality traits are determined based on norms from high-risk adolescents in the same age range who participated in previous trials on personality-targeted interventions.

Behavioral: Personality-targeted Interventions

Interventions

The Personality-targeted Interventions (i.e., Preventure programme) are 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, Anxiety Sensitivity, Impulsivity, and Sensation Seeking. Each intervention will involve two 90-minute sessions, with an average of 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 and include real life 'scenarios' shared by high-risk local youth with similar personality profiles.

Also known as: Preventure programme
High-risk youth

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Severe cognitive impairments
  • Acute psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batshaw Youth and Family Centres

Montreal, Quebec, H9S 1X4, Canada

Location

Related Publications (4)

  • 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.

    PMID: 30723431BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 19683400BACKGROUND
  • 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.

    PMID: 27909645BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Hanie Edalati, PhD

    St-Justine Hospital, University of Montreal

    PRINCIPAL INVESTIGATOR
  • Patricia J Conrod, PhD

    St-Justine Hospital, University of Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

August 19, 2019

First Posted

November 14, 2019

Study Start

October 2, 2019

Primary Completion

May 30, 2020

Study Completion

August 1, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations