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临床试验/NCT04162977
NCT04162977已完成不适用

Well-Venture Pilot Project: Adapting Personality-Targeted Interventions for Reducing Substance Misuse and Related Outcomes in Youth in Youth Protection Services

St. Justine's Hospital2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
Rate of Depression Symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Severe cognitive impairments
  • Acute psychotic symptoms

结局指标

主要结局

Rate of Depression Symptoms

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

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.

Self-reported Anxiety Sensitivity

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

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.

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

时间窗: Baseline during two intervention sessions

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.

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

时间窗: Baseline

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

Feasibility Outcome 3: Youth-generated feedback

时间窗: Baseline (directly post-intervention)

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).

Rate of Binge Drinking

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

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.

Total Number of Drug Used

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

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.

Rate of Alcohol-related Harm

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

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.

Self-reported Impulsivity

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

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.

Rate of Drug-related Harm

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

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.

次要结局

  • 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)
  • Rate of Complex-Post-traumatic Stress Disorder Symptoms(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)
  • Rate of Post-traumatic Stress Disorder Symptoms(Baseline (pre-intervention), 3-month post-intervention, and 6-month post-intervention)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanie Edalati

Postdoctoral Fellow

St. Justine's Hospital

研究点 (2)

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