跳至主要内容
临床试验/NCT07456631
NCT07456631招募中不适用

ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence

University of Coimbra1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
1
主要终点
Change in Core Social Fears

研究概览

简要总结

Social functioning, fundamental to adolescent's development and mental health, may be impaired by polarizing problematic social functioning, namely externalizing symptoms manifested by Oppositional Defiant Disorder and internalizing symptoms portrayed by Social Anxiety Disorder. Despite their high prevalence and similar associated impairments, interventions targeting these disorders are differently conceived. Alternatively, Acceptance and Commitment Therapy (ACT) proposes that those apparently dissimilar social difficulties are rooted in similar processes. Though research has shown ACTs' efficacy in changing adults' internalizing and externalizing symptoms, studies on the potential of ACT in changing those problematics in adolescence are still scarce. This project proposes to conduct three clinical trials to test the efficacy and (dis)similarities of an transdiagnostic ACT intervention for changing internalizing and externalizing symptomatology in adolescents. It will amplify the transdiagnostic and evidence-based application of ACT to adolescents presenting polarizing disorders in the social functioning spectrum.

详细描述

Adolescence represents vulnerability to mental health issues, with approximately 1 in 7 adolescents presenting mental disorders that, when untreated, lead to significant impairments and less long-term quality of life. Given that adolescents are hypersensitive to social stimuli and social exclusion, and place particular value in peer approval/influence, peer rejection in adolescence seems to increase the risk for developing mental disorders. Conversely, positive peer relationships may protect against mental health problems and promote resilience. This buffering effect may be absent in disorders related to adolescents' social functioning.

Oppositional Defiant Disorder (ODD) and Social Anxiety Disorder (SAD) are polarizing examples of problematic social functioning as adolescents with these diagnoses view the social world as a place of potential evaluation and rejection. ODD and SAD have alarming lifetime prevalence rates in adolescence, suggesting that these conditions are highly stable and predict later emotional and behavioral problems. Though their impact on socialization is similar (i.e., rejection, isolation), they have been differently conceptualized and intervened with (e.g., self-focused attention in SAD versus hostile attribution style in ODD).

Alternatively, Acceptance and Commitment Therapy (ACT) focuses on common underlying processes, rather than specific symptoms, as the foundation for social difficulties such as ODD or SAD. Specifically, Psychological Inflexibility (PI) - rigid attempts to control internal experiences and the inability to adapt one's behavior in the service of freely chosen values - is proposed as the basis of human suffering. PI stems from six interrelated processes: Cognitive Fusion, Experiential Avoidance, Attachment to the Conceptualized Self, Dominance of the Conceptualized Past/Feared Future, Lack of Values Clarity, and Inaction, Impulsivity or Avoidant Persistence. ACT aims to cultivate Psychological Flexibility (PF) - the ability to be in the present moment with willingness to be with the internal experience non-judgmentally and to act in a way that is congruent with ones' values. ACT relies on 6 core principles to cultivate PF, each opposing to one of the PI processes: Acceptance, Cognitive Defusion, Contact with Present Moment, Self-As-Context, Values, and Committed Action. Although there is evidence about PI processes as transdiagnostic factors underlying psychopathology and about the efficacy of ACT on adults' mental health in comparison with control conditions, research targeting adolescent samples (though emerging) is lacking.

Research has supported the efficacy of ACT interventions in adults with externalizing behavior. However, only a few works used ACT to address externalizing behavior in adolescents, though results were promising. There is evidence supporting the efficacy of ACT in treating SAD, though, again, only a few studies addressed this issue and found promising outcomes with adolescents. None of these works considered change in the processes of PI/PF and its intercorrelation with change in symptomatology, nor ACT's potential to promote similar change in these polarizing examples of problematic social functioning.

To overcome these shortcomings, we propose to take an ACT approach to adolescent ODD and SAD in a sequence of three clinical trials: A pilot single-arm clinical study of ACT applied to ODD, a Randomized Controlled Clinical Trial of ACT applied to SAD, and an equivalence clinical trial of ACT applied to ODD and SAD. These studies will be conducted to explore the (dis)similarity in efficacy of ACT for ODD and SAD, considering symptomatology, PI/PF processes and mental health as outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Main diagnosis of Oppositional Defiant Disorder (ODD)
  • Meeting diagnostic criteria for Social Anxiety Disorder (SAD)
  • Main diagnosis of Social Anxiety Disorder (SAD)
  • Meeting diagnostic criteria for Oppositional Defiant Disorder (ODD)

排除标准

  • (applies to both studies):
  • Impaired cognitive development based on school records
  • Presence of psychotic symptoms according to the diagnostic interview
  • Diagnosis of autism spectrum disorder according to the diagnostic interview
  • Currently undergoing another psychological intervention for a psychiatric condition
  • Note: Comorbid conditions other than the co-occurrence of ODD and SAD will not be considered exclusion criteria.

研究组 & 干预措施

Intervention Group (study I)

Experimental

Adolescents meeting diagnostic criteria for Oppositional Defiant Disorder. Participants receive the ACTsocially intervention. Assessments are conducted at pre-intervention and post-intervention (11 weeks later), and at 3 and 6-month follow-up.

干预措施: ACTsocially (Behavioral)

Control Group (study II)

No Intervention

Adolescents meeting diagnostic criteria for Social Anxiety Disorder. Participants do not receive the ACTsocially intervention. Assessments are conducted at baseline, post-assessment (11 weeks later), and at 3 and 6-month follow-up.

Intervention Group (study II)

Experimental

Adolescents meeting diagnostic criteria for Social Anxiety Disorder. Participants receive the ACTsocially intervention. Assessments are conducted at pre-intervention, post-intervention (11 weeks later), and at 3 and 6-month follow-up.

干预措施: ACTsocially (Behavioral)

结局指标

主要结局

Change in Core Social Fears

时间窗: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months

The CSFS-A is a self-report questionnaire designed to assess adolescents' experiences of anxiety and behavioral avoidance across a range of commonly encountered social situations. Originally comprising 34 items answered twice - once for anxiety intensity and once for avoidance frequency - items are rated on a five-point Likert scale (1 = none / never, 5 = very much / almost always) for each dimension. In the refined measurement model, this scale is conceptualized in terms of three core social fear dimensions (i.e. Interaction, Performance, and Observation) and a general avoidance factor. Each of the resulting subscales (Observation, Performance, Interaction) and the General Avoidance factor yields a composite score reflecting the intensity of social fears or the degree of avoidance behavior. Internal consistency values for these scales were demonstrated to be acceptable to good across community and clinical adolescent samples.

Change in Disruptive Behavior

时间窗: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months

The DBDRS is a 45-item hetero-report scale for the assessment of DSM-V symptoms of attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD) and conduct disorder (CD). Items (e.g., "Argues with adults") are rated using a four-point Likert-type scale (0 = "not at all" to 3 = "very much"). The DBDRS is organized into four subscales - inattention, hyperactivity/impulsivity, oppositional defiant disorder, and conduct disorder. For the current work, only the ODD scale will be used in the intervention group of Study I, both in its original version for caregivers' (i.e., parents/teachers) report and in a version designed within this work for adolescents' self-report. The original version achieved an excellent level of internal consistency (α = 0.93 for the ODD scale). Invariance testing also suggested that the scale's internal structure is similar across key demographics such as age and sex.

Change in Aggressive Behaviors

时间窗: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months

The RPEQ is a 14-item self-report scale that assesses aggression, victimization and prosocial behavior. Each item is presented in two versions, one for practicing a given behavior and another for receiving that behavior. For the current work only the practice of aggression measures will be used within the intervention group of Study I. Items are rated on 5-point Likert scale (ranging from 1 = "never" to 5 = "a few times a week") and are organized into overt aggression, relational aggression, and reputational aggression. Factors achieved at least acceptable internal consistency values with Cronbach's alpha values of .88 for overt aggression, .75 for relational aggression, and .91 for reputational aggression. Evidence was also found in favor of the construct validity of these measures.

次要结局

  • Change in Psychological Flexibility(Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months)
  • Change in Mental Health(Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francisca Alves

M.Sc.

University of Coimbra

研究点 (1)

Loading locations...

相似试验