Substance Use Disorders Clinical Trial
Official title:
Well-Venture Pilot Project: Adapting Personality-Targeted Interventions for Reducing Substance Misuse and Related Outcomes in Youth in Youth Protection Services
Verified date | October 2020 |
Source | St. Justine's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | August 1, 2020 |
Est. primary completion date | May 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 19 Years |
Eligibility | Inclusion Criteria: • Receiving services from Batshaw Youth and Family Centres under the Youth Protection Services Exclusion Criteria: - Severe cognitive impairments - Acute psychotic symptoms |
Country | Name | City | State |
---|---|---|---|
Canada | Batshaw Youth and Family Centres | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital | Batshaw Youth and Family Centres |
Canada,
Conrod PJ. Personality-Targeted Interventions for Substance Use and Misuse. Curr Addict Rep. 2016;3(4):426-436. Epub 2016 Nov 4. Review. — View 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. Review. — View 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.
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Rate of Anxiety Symptoms | Change in the rate of anxiety symptoms is assessed using anxiety subscale of Brief Symptom Inventory. The anxiety 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 anxiety symptoms. | Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention | |
Secondary | Emotion Dysregulation | Change in the total and dimensions scores of emotion dysregulation is measured by the Difficulties in Emotion Regulation Scale-Short Form (DERS-18). This scale consists of 18-items rated on a 5-point scale, from 1 (almost never) to 5 (almost always). Items capture six dimensions of emotion dysregulation: non-acceptance of emotional responses, difficulties engaging in goal-directed behaviour, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Responses are summed to create a total score of emotion dysregulation ranging from 18 to 90. Three items for each dimension subscale are summed to create a total score for that dimension ranging from 3 to 15. Higher scores indicate higher more emotion dysregulation problems. | Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention | |
Secondary | Self-esteem Score | Change in the score of self-esteem is assessed using Rosenberg Self-Esteem Scale. Rosenberg Self-Esteem Scale assesses global self-worth by measuring both positive and negative feelings about the self. The scale consists of 10 items rated on a 4-point Likert scale ranging from 0=strongly disagree to 3=strongly agree. Responses are summed to create a total score ranging from 0 to 30. Higher scores indicate higher self-esteem. | Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention | |
Secondary | Rate of Conduct Problems | Change in the rate of conduct symptoms is assessed using conduct problem subscale of Strengths and Difficulties Questionnaire. The conduct problem subscale includes five items each rated on a three-point scale (0 = not true, 1 = sometimes true, 2 = certainly true). Responses are summed to create a total score ranging from 0 to 10. Higher values represent higher rates of conduct symptoms. | Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention | |
Secondary | Rate of Hyperactivity/inattentive Problems | Change in the rate of hyperactivity/inattentive symptoms is assessed using hyperactivity/inattentive subscale of Strengths and Difficulties Questionnaire. The hyperactivity/inattentive includes five items each rated on a three-point scale (0 = not true, 1 = sometimes true, 2 = certainly true). Responses are summed to create a total score ranging from 0 to 10. Higher values represent higher rates of hyperactivity/inattentive symptoms. | Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention | |
Secondary | Rate of Post-traumatic Stress Disorder Symptoms | Change in the rate of post-traumatic stress disorder (PTSD) symptoms is measured using the International Trauma Questionnaire for the International Classification of Diseases 11th Revision (ICD-11). Participants are first asked to identify 'the experience that troubles them most' and briefly describe it and then to respond to 9 items asking about their problems (i.e. symptoms) in the past month related to the experience. Responses are rated on a five-point scale (0 = not at all to 5 = extremely). A diagnosis of PTSD requires the endorsement of one of two symptoms from the symptom clusters of (1) reexperiencing in the here and now, (2) avoidance, and (3) sense of current threat, plus endorsement of at least one indicator of functional impairment associated with these symptoms. Endorsement of a symptom or functional impairment item is defined as a score of = 2. | Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention | |
Secondary | Rate of Complex-Post-traumatic Stress Disorder Symptoms | Change in the rate of complex-post-traumatic stress disorder (CPTSD) symptoms is measured using the International Trauma Questionnaire for the International Classification of Diseases 11th Revision. Participants are first asked to identify and briefly describe 'the experience that troubles them most' and then to respond to 18 items asking about their symptoms in the past month related to the experience on a five-point scale (0 = not at all to 5 = extremely). These items evaluate PTSD symptoms and disturbances in self-organization symptoms. A diagnosis of CPTSD requires the endorsement of one of two symptoms of the three PTSD symptoms clusters and one of two symptoms of the three disturbances in self-organization clusters. Endorsement of at least one indicator of functional impairment related to PTSD symptoms and one related to the disturbances in self-organization symptoms is required. Endorsement of a symptom or functional impairment item is defined as a score = 2. | Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention |
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