Social Anxiety Disorder (SAD)ACTsociallyNCT07456631
ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence
A study testing ACTsocially in people with Social Anxiety Disorder (SAD) and Oppositional Defiant Disorder, run by University of Coimbra at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Social Anxiety Disorder (SAD), Oppositional Defiant Disorder
- What is being tested?
- ACTsocially
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Study I:
- Main diagnosis of Oppositional Defiant Disorder (ODD)
- Meeting diagnostic criteria for Social Anxiety Disorder (SAD)
- Study II:
- Main diagnosis of Social Anxiety Disorder (SAD)
- Meeting diagnostic criteria for Oppositional Defiant Disorder (ODD)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
FPCEUC
Coimbra
FPCEUC, +351 239 851 450, dir@fpce.uc.pt
About this study
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.
Read the detailed description
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.
The research team will adapt, implement, and investigate the efficacy of a face-to-face ACT Intervention to adolescents presenting ODD or SAD via: 1. Changes in primary (i.e., disruptive behavior and anxiety symptoms) and secondary (i.e., mental health and PI/PF processes) outcomes following intervention - significant improvements are expected at post-intervention (i.e., in the SAD diagnosed intervention group in comparison with a control group and in the ODD diagnosed intervention group); 2. Examining the stability of change over time (i.e., 3- and 6-months follow-up) - improvements are expected to be maintained; 3. Comparing the efficacy of ACT between both intervention groups - Similar effects are expected on outcome measures for both intervention groups; 4. Investigating mechanisms of change following intervention in both intervention groups - Change in PI/PF is expected to predict change in outcome variables in both intervention groups.
All procedures involved in this project (described elsewhere in this form) were approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences, University of Coimbra and the General Directorate of Education authorized the data collection protocol to be implemented in school contexts. Informed consent from adolescents and their parents/legal guardians will be required for all potential participants prior to any data collection. Adolescents and their parents/legal guardians will be informed that participation is voluntary and that they can decline to participate at any time during the project without any negative consequence. Moreover, they will be informed that the confidentiality of responses will be assured in all moments.
- Being tested
- ACTsocially
- Keywords
- Acceptance and Commitment Therapy, Adolescents, Oppositional Defiant Disorder, Social Anxiety Disorder, Psychological Flexibility, Psychological Inflexibility
- Medical subject headings
- Phobia, Social, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTsociallyBehavioural
Adapted from the ACT@TeenSAD intervention program developed within the TeenSAD research project (NCT04979676), the ACTsocially intervention program is a structured, manualized face-to-face transdiagnostic intervention grounded in the PF model of ACT. The intervention consists of 11 weekly 50-minute sessions. Core content is organized across four modules (1: The role of psychological (in)flexibility; 2: The foundation of psychological flexibility; 3: Psychological flexibility in action; 4: Revision of gains and relapse prevention). Sessions follow a consistent structure beginning with a mindfulness exercise, followed by a brief review of the previous session and discussion of the adolescent's experiences with the between-session commitment. The therapist then introduces one or more activities centered on the weekly theme, which may involve psychoeducation, metaphors, or experiential exercises. Each session concludes with the introduction of a new commitment for the following week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ACTsocially |
| 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. Receives: Behavioral: ACTsocially |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Core Social Fears
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.
Measured: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months
Change in Disruptive Behavior
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.
Measured: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months
Change in Aggressive Behaviors
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.
Measured: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months
Secondary outcomes (2)
Change in Psychological Flexibility
The MPFI-24A is a 24-item self-report scale for the assessment of psychological flexibility (PF) and inflexibility (PI) that will be used to assess all groups considered in this research. The scale comprises 12 subscales, representing the six PF processes and the six PI processes. Items (e.g., "I opened myself to all of my feelings, the good and the bad") are answered on a 6-point Likert scale (ranging from 1 = 'never true' to 6 = 'always true') regarding how true the item was for the respondent in the previous 2 weeks. In the adolescent version, the composite indices (PF and PI) showed excellent internal consistency (α = .90 and α = .85, respectively) and the 12 factors revealed acceptable reliability with values that varied between .61 and .83.
Measured: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months
Change in Mental Health
The MHC-SF is a 14-item self-report scale for the assessment of adolescents' mental health estimated from the perceived degree of emotional, social and psychological well-being; it will be used to assess all groups considered in this research. Items are answered on a 5-point Likert scale (ranging from 0 = "never" to 5 = "every day") regarding the number of times during the previous month the respondent felt a certain way. The used Portuguese version achieved at least good levels of internal consistency (α = 0.90 on the global scale and between 0.80 and 0.85 on the subscales.
Measured: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Sep 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety Disorder (SAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This investigation comprises three sequential studies. Study I (pilot study) is a single-arm, pre-post-follow-up study design with an ODD diagnosed intervention group (n=18), receiving the ACTsocially intervention. Study II is a pre-post-follow-up randomized controlled parallel-group superiority trial evaluating the efficacy of the ACTsocially intervention in a SAD diagnosed intervention group compared to a control group. Participants will be randomly assigned via institutions as clusters to one of two conditions: Clinical Intervention (n = 18), No intervention Control (n = 18). After the project, students in the control group will be identified and referred to the schools' psychology services, with their appropriate consent. Study III is a parallel-group equivalence trial evaluating the comparable efficacy of the ACTsocially intervention in the ODD and SAD diagnosed intervention groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Responsible party
- Principal investigator, Francisca Alves, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456631
- Sponsor's protocol ID
- 2023.03831.BD
- Other IDs
- 2023
- Acronym
- ACTsocially
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
28. Matos, A. P., André, R. S., Cherpe, S., Rodrigues, D., Figueira, C., & Pinto, A. M. (2010). Estudo Psicométrico preliminar da Mental Health Continuum - Short Form - for youth numa amostra de adolescentes portugueses. Psychologica, 53, 131-156. https://doi.org/10.14195/1647-8606_53_7
Rolffs JL, Rogge RD, Wilson KG. Disentangling Components of Flexibility via the Hexaflex Model: Development and Validation of the Multidimensional Psychological Flexibility Inventory (MPFI). Assessment. 2018 Jun;25(4):458-482. doi: 10.1177/1073191116645905. Epub 2016 May 5.
PubMed 27152011Queiros AN, Vagos P. Measures of aggression and victimization in portuguese adolescents: Cross-cultural validation of the Revised Peer Experience Questionnaire. Psychol Assess. 2016 Oct;28(10):e141-e151. doi: 10.1037/pas0000363. Epub 2016 Jul 18.
PubMed 27427943Fosco WD, Babinski DE, Waschbusch DA. The Disruptive Behavior Disorders Rating Scale: Updated Factor Structure, Measurement Invariance, and National Caregiver Norms. J Pediatr Psychol. 2023 May 20;48(5):468-478. doi: 10.1093/jpepsy/jsad006.
PubMed 36881692Vagos P, Figueiredo DV, Cunha M. The Core Social Fears Scale for Adolescents: Psychometric appraisal based on community and clinical samples. Eur Child Adolesc Psychiatry. 2026 Jan;35(1):191-204. doi: 10.1007/s00787-025-02824-4. Epub 2025 Aug 4.
PubMed 4075983123. Alves, F., Figueiredo, D. V., & Vagos, P. (2022). Acceptance and Commitment Therapy for Social Anxiety Disorder in Adolescence: Preliminary Appraisal Based on a Case Study Approach. Clinical Case Studies, 0(0). https://doi.org/10.1177/15346501221144069
Azadeh SM, Kazemi-Zahrani H, Besharat MA. Effectiveness of Acceptance and Commitment Therapy on Interpersonal Problems and Psychological Flexibility in Female High School Students With Social Anxiety Disorder. Glob J Health Sci. 2015 Jul 12;8(3):131-8. doi: 10.5539/gjhs.v8n3p131.
PubMed 26493425Caletti E, Massimo C, Magliocca S, Moltrasio C, Brambilla P, Delvecchio G. The role of the acceptance and commitment therapy in the treatment of social anxiety: An updated scoping review. J Affect Disord. 2022 Aug 1;310:174-182. doi: 10.1016/j.jad.2022.05.008. Epub 2022 May 7.
PubMed 3553754420. Livheim, F., Tengström, A., Andersson, G., Dahl, J., Björck, C., & Rosendahl, I. (2020). A quasi-experimental, multicenter study of acceptance and commitment therapy for antisocial youth in residential care. Journal of Contextual Behavioral Science, 16, 119-127. https://doi.org/10.1016/j.jcbs.2020.03.008
19. Theodore-Oklota, C., Orsillo, S. M., Lee, J. K., & Vernig, P. M. (2014). A pilot of an acceptance-based risk reduction program for relational aggression for adolescents. Journal of Contextual Behavioral Science, 3, 109-116. https://doi.org/10.1016/j.jcbs.2014.03.001
18. Berkout, O. V., Tinsley, D., & Flynn, M. K. (2019). A review of anger, hostility, and aggression from an ACT perspective. Journal of Contextual Behavioral Science, 11, 34-43. https://doi.org/10.1016/j.jcbs.2018.12.001
17. Moreno, P. M., & Blasco, R. Q. (2019). Una revisión de la aplicación de la Terapia de Aceptación y Compromiso con niños y adolescentes. [Acceptance and commitment therapy with children and adolescents: A review.]. International Journal of Psychology & Psychological Therapy, 19, 173-188.
Powers MB, Zum Vorde Sive Vording MB, Emmelkamp PM. Acceptance and commitment therapy: a meta-analytic review. Psychother Psychosom. 2009;78(2):73-80. doi: 10.1159/000190790. Epub 2009 Jan 14.
PubMed 19142046A-Tjak JG, Davis ML, Morina N, Powers MB, Smits JA, Emmelkamp PM. A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom. 2015;84(1):30-6. doi: 10.1159/000365764. Epub 2014 Dec 24.
PubMed 25547522Dimidjian S, Arch JJ, Schneider RL, Desormeau P, Felder JN, Segal ZV. Considering Meta-Analysis, Meaning, and Metaphor: A Systematic Review and Critical Examination of "Third Wave" Cognitive and Behavioral Therapies. Behav Ther. 2016 Nov;47(6):886-905. doi: 10.1016/j.beth.2016.07.002. Epub 2016 Jul 14.
PubMed 27993339
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence
- ClinicalTrials.gov ID
- NCT07456631
- Acronym / sponsor ID
- ACTsocially / 2023.03831.BD
- Keywords
- Acceptance and Commitment Therapy, Adolescents, Oppositional Defiant Disorder, Social Anxiety Disorder, Psychological Flexibility, Psychological Inflexibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The research team will adapt, implement, and investigate the efficacy of a face-to-face ACT Intervention to adolescents presenting ODD or SAD via: 1. Changes in primary (i.e., disruptive behavior and anxiety symptoms) and secondary (i.e., mental health and PI/PF processes) outcomes following intervention - significant improvements are expected at post-intervention (i.e., in the SAD diagnosed intervention group in comparison with a control group and in the ODD diagnosed intervention group); 2. Examining the stability of change over time (i.e., 3- and 6-months follow-up) - improvements are expected to be maintained; 3. Comparing the efficacy of ACT between both intervention groups - Similar effects are expected on outcome measures for both intervention groups; 4. Investigating mechanisms of change following intervention in both intervention groups - Change in PI/PF is expected to predict change in outcome variables in both intervention groups.
All procedures involved in this project (described elsewhere in this form) were approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences, University of Coimbra and the General Directorate of Education authorized the data collection protocol to be implemented in school contexts. Informed consent from adolescents and their parents/legal guardians will be required for all potential participants prior to any data collection. Adolescents and their parents/legal guardians will be informed that participation is voluntary and that they can decline to participate at any time during the project without any negative consequence. Moreover, they will be informed that the confidentiality of responses will be assured in all moments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This investigation comprises three sequential studies. Study I (pilot study) is a single-arm, pre-post-follow-up study design with an ODD diagnosed intervention group (n=18), receiving the ACTsocially intervention. Study II is a pre-post-follow-up randomized controlled parallel-group superiority trial evaluating the efficacy of the ACTsocially intervention in a SAD diagnosed intervention group compared to a control group. Participants will be randomly assigned via institutions as clusters to one of two conditions: Clinical Intervention (n = 18), No intervention Control (n = 18). After the project, students in the control group will be identified and referred to the schools' psychology services, with their appropriate consent. Study III is a parallel-group equivalence trial evaluating the comparable efficacy of the ACTsocially intervention in the ODD and SAD diagnosed intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (study I) | Experimental | Behavioral: ACTsociallyAdolescents 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. |
| 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 | Behavioral: ACTsociallyAdolescents 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTsociallyAdapted from the ACT@TeenSAD intervention program developed within the TeenSAD research project (NCT04979676), the ACTsocially intervention program is a structured, manualized face-to-face transdiagnostic intervention grounded in the PF model of ACT. The intervention consists of 11 weekly 50-minute sessions. Core content is organized across four modules (1: The role of psychological (in)flexibility; 2: The foundation of psychological flexibility; 3: Psychological flexibility in action; 4: Revision of gains and relapse prevention). Sessions follow a consistent structure beginning with a mindfulness exercise, followed by a brief review of the previous session and discussion of the adolescent's experiences with the between-session commitment. The therapist then introduces one or more activities centered on the weekly theme, which may involve psychoeducation, metaphors, or experiential exercises. Each session concludes with the introduction of a new commitment for the following week. | Behavioural | Intervention Group (study I), Intervention Group (study II) |
Primary outcome
Change in Core Social Fears
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Change in Psychological Flexibility
Time frame: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months
Change in Mental Health
Time frame: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background28. Matos, A. P., André, R. S., Cherpe, S., Rodrigues, D., Figueira, C., & Pinto, A. M. (2010). Estudo Psicométrico preliminar da Mental Health Continuum - Short Form - for youth numa amostra de adolescentes portugueses. Psychologica, 53, 131-156. https://doi.org/10.14195/1647-8606_53_7
- Background: PubMed 27152011Rolffs JL, Rogge RD, Wilson KG. Disentangling Components of Flexibility via the Hexaflex Model: Development and Validation of the Multidimensional Psychological Flexibility Inventory (MPFI). Assessment. 2018 Jun;25(4):458-482. doi: 10.1177/1073191116645905. Epub 2016 May 5.
- Background: PubMed 27427943Queiros AN, Vagos P. Measures of aggression and victimization in portuguese adolescents: Cross-cultural validation of the Revised Peer Experience Questionnaire. Psychol Assess. 2016 Oct;28(10):e141-e151. doi: 10.1037/pas0000363. Epub 2016 Jul 18.
- Background: PubMed 36881692Fosco WD, Babinski DE, Waschbusch DA. The Disruptive Behavior Disorders Rating Scale: Updated Factor Structure, Measurement Invariance, and National Caregiver Norms. J Pediatr Psychol. 2023 May 20;48(5):468-478. doi: 10.1093/jpepsy/jsad006.
- Background: PubMed 40759831Vagos P, Figueiredo DV, Cunha M. The Core Social Fears Scale for Adolescents: Psychometric appraisal based on community and clinical samples. Eur Child Adolesc Psychiatry. 2026 Jan;35(1):191-204. doi: 10.1007/s00787-025-02824-4. Epub 2025 Aug 4.
- Background23. Alves, F., Figueiredo, D. V., & Vagos, P. (2022). Acceptance and Commitment Therapy for Social Anxiety Disorder in Adolescence: Preliminary Appraisal Based on a Case Study Approach. Clinical Case Studies, 0(0). https://doi.org/10.1177/15346501221144069
- Background: PubMed 26493425Azadeh SM, Kazemi-Zahrani H, Besharat MA. Effectiveness of Acceptance and Commitment Therapy on Interpersonal Problems and Psychological Flexibility in Female High School Students With Social Anxiety Disorder. Glob J Health Sci. 2015 Jul 12;8(3):131-8. doi: 10.5539/gjhs.v8n3p131.
- Background: PubMed 35537544Caletti E, Massimo C, Magliocca S, Moltrasio C, Brambilla P, Delvecchio G. The role of the acceptance and commitment therapy in the treatment of social anxiety: An updated scoping review. J Affect Disord. 2022 Aug 1;310:174-182. doi: 10.1016/j.jad.2022.05.008. Epub 2022 May 7.
- Background20. Livheim, F., Tengström, A., Andersson, G., Dahl, J., Björck, C., & Rosendahl, I. (2020). A quasi-experimental, multicenter study of acceptance and commitment therapy for antisocial youth in residential care. Journal of Contextual Behavioral Science, 16, 119-127. https://doi.org/10.1016/j.jcbs.2020.03.008
- Background19. Theodore-Oklota, C., Orsillo, S. M., Lee, J. K., & Vernig, P. M. (2014). A pilot of an acceptance-based risk reduction program for relational aggression for adolescents. Journal of Contextual Behavioral Science, 3, 109-116. https://doi.org/10.1016/j.jcbs.2014.03.001
- Background18. Berkout, O. V., Tinsley, D., & Flynn, M. K. (2019). A review of anger, hostility, and aggression from an ACT perspective. Journal of Contextual Behavioral Science, 11, 34-43. https://doi.org/10.1016/j.jcbs.2018.12.001
- Background17. Moreno, P. M., & Blasco, R. Q. (2019). Una revisión de la aplicación de la Terapia de Aceptación y Compromiso con niños y adolescentes. [Acceptance and commitment therapy with children and adolescents: A review.]. International Journal of Psychology & Psychological Therapy, 19, 173-188.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTsocially in people with Social Anxiety Disorder (SAD) and Oppositional Defiant Disorder, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisca Alves M.Sc. (+351 914309297, mfrancisca.mca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Core Social Fears (time frame: Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07456631, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.