NCT07456631

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress68%
Sep 2023Sep 2027

Study Start

First participant enrolled

September 1, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

March 2, 2026

Last Update Submit

March 6, 2026

Conditions

Keywords

Acceptance and Commitment TherapyAdolescentsOppositional Defiant DisorderSocial Anxiety DisorderPsychological FlexibilityPsychological Inflexibility

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline, Week 11, Follow-Up 3 Months and Follow-Up 6 Months

Secondary Outcomes (2)

  • 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

Study Arms (3)

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.

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.

Behavioral: ACTsocially

Interventions

ACTsociallyBEHAVIORAL

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.

Intervention Group (study I)Intervention Group (study II)

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FPCEUC

Coimbra, Portugal

RECRUITING

Related Publications (28)

  • 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

    BACKGROUND
  • 27. Rolffs, J. L., Rogge, R. D., & Wilson, K. G. (2018). Disentangling Components of Flexibility via the Hexaflex Model: Development and Validation of the Multidimensional Psychological Flexibility Inventory (MPFI). Assessment, 25(4), 458-482. https://doi.org/10.1177/1073191116645905

    BACKGROUND
  • 26. Queirós, A. N., & Vagos, P. (2016). Measures of aggression and victimization in portuguese adolescents: Cross-cultural validation of the Revised Peer Experience Questionnaire. Psychological Assessment, 28(10), e141-e151. https://doi.org/10.1037/pas0000363

    BACKGROUND
  • 25. Fosco, W. D., Babinski, D. E., & Waschbusch, D. A. (2023). The disruptive behavior disorders rating scale: Updated factor structure, measurement invariance, and national caregiver norms. Journal of Pediatric Psychology, 48(5), 468-478. https://doi.org/10.1093/jpepsy/jsad006

    BACKGROUND
  • 24. Vagos, P., Figueiredo, D.V. & Cunha, M. The Core Social Fears Scale for Adolescents: Psychometric appraisal based on community and clinical samples. Eur Child Adolesc Psychiatry (2025). https://doi.org/10.1007/s00787-025-02824-4

    BACKGROUND
  • 23. 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
  • 22. Azadeh, S. M., Kazemi-Zahrani, H., & Besharat, M. A. (2015). Effectiveness of Acceptance and Commitment Therapy on Interpersonal Problems and Psychological Flexibility in Female High School Students With Social Anxiety Disorder. Global Journal of Health Science, 8(3), 131-138. https://doi.org/10.5539/gjhs.v8n3p131

    BACKGROUND
  • 21. Caletti, E., Massimo, C., Magliocca, S., Moltrasio, C., Brambilla, P., & Delvecchio, G. (2022). The role of the acceptance and commitment therapy in the treatment of social anxiety: An updated scoping review. Journal of Affective Disorders, 310, 174-182. https://doi.org/10.1016/j.jad.2022.05.008

    BACKGROUND
  • 20. 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 16. Powers, M. B., Vörding, M. B. Z. V. S., & Emmelkamp, P. M. G. (2009). Acceptance and Commitment Therapy: A Meta-Analytic Review. Psychotherapy and Psychosomatics, 78(2), 73-80. https://doi.org/10.1159/000190790

    BACKGROUND
  • 15. A-Tjak, J. G. L., Davis, M. L., Morina, N., Powers, M. B., Smits, J. A. J., & Emmelkamp, P. M. G. (2015). A Meta-Analysis of the Efficacy of Acceptance and Commitment Therapy for Clinically Relevant Mental and Physical Health Problems. Psychotherapy and Psychosomatics, 84(1), 30-36. https://doi.org/10.1159/000365764

    BACKGROUND
  • 14. Dimidjian, S., Arch, J. J., Schneider, R. L., Desormeau, P., Felder, J. N., & Segal, Z. V. (2016). Considering Meta-Analysis, Meaning, and Metaphor: A Systematic Review and Critical Examination of 'Third Wave' Cognitive and Behavioral Therapies. Behavior Therapy, 47(6), 886-905. https://doi.org/10.1016/j.beth.2016.07.002

    BACKGROUND
  • 13. Gloster, A. T., Walder, N., Levin, M. E., Twohig, M. P., & Karekla, M. (2020). The empirical status of acceptance and commitment therapy: A review of meta-analyses. Journal of Contextual Behavioral Science, 18, 181-192. https://doi.org/10.1016/j.jcbs.2020.09.009

    BACKGROUND
  • 12. Hayes, S. C., Pistorello, J., & Levin, M. E. (2012). Acceptance and Commitment Therapy as a Unified Model of Behavior Change. The Counseling Psychologist, 40(7), 976-1002. https://doi.org/10.1177/0011000012460836

    BACKGROUND
  • 11. Hayes, S. C., Luoma, J. B., Bond, F. W., Masuda, A., & Lillis, J. (2006). Acceptance and commitment therapy: Model, processes and outcomes. Behaviour Research and Therapy, 44(1), 1-25. https://doi.org/10.1016/j.brat.2005.06.006

    BACKGROUND
  • 10. Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (1999). Acceptance and commitment therapy: An experiential approach to behavior change. Guilford Press.

    BACKGROUND
  • 9. Hiemstra, W., De Castro, B. O., & Thomaes, S. (2019). Reducing Aggressive Children's Hostile Attributions: A Cognitive Bias Modification Procedure. Cognitive Therapy and Research, 43(2), 387-398. https://doi.org/10.1007/s10608-018-9958-x

    BACKGROUND
  • 8. Leigh, E., & Clark, D. M. (2018). Understanding Social Anxiety Disorder in Adolescents and Improving Treatment Outcomes: Applying the Cognitive Model of Clark and Wells (1995). Clinical Child and Family Psychology Review, 21(3), 388-414. https://doi.org/10.1007/s10567-018-0258-5

    BACKGROUND
  • 7. Merikangas, K. R., He, J.-P., Burstein, M., Swanson, S. A., Avenevoli, S., Cui, L., Benjet, C., Georgiades, K., & Swendsen, J. (2010). Lifetime prevalence of mental disorders in U.S. adolescents: Results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). Journal of the American Academy of Child and Adolescent Psychiatry, 49(10), 980-989. https://doi.org/10.1016/j.jaac.2010.05.017

    BACKGROUND
  • 6. van Harmelen, A.-L., Kievit, R. A., Ioannidis, K., Neufeld, S., Jones, P. B., Bullmore, E., Dolan, R., Fonagy, P., & Goodyer, I. (2017). Adolescent friendships predict later resilient functioning across psychosocial domains in a healthy community cohort. Psychological Medicine, 47(13), 2312-2322. https://doi.org/10.1017/S0033291717000836

    BACKGROUND
  • 5. Arseneault, L. (2018). Annual Research Review: The persistent and pervasive impact of being bullied in childhood and adolescence: implications for policy and practice. Journal of Child Psychology and Psychiatry, and Allied Disciplines, 59(4), 405-421. https://doi.org/10.1111/jcpp.12841

    BACKGROUND
  • 4. Orben, A., Tomova, L., & Blakemore, S.-J. (2020). The effects of social deprivation on adolescent development and mental health. The Lancet. Child & Adolescent Health, 4(8), 634. https://doi.org/10.1016/S2352-4642(20)30186-3

    BACKGROUND
  • 3. Blakemore, S.-J., & Mills, K. L. (2014). Is adolescence a sensitive period for sociocultural processing? Annual Review of Psychology, 65, 187-207. https://doi.org/10.1146/annurev-psych-010213-115202

    BACKGROUND
  • 2. UNICEF (Ed.). (2021). On my mind: Promoting, protecting and caring for children's mental health. UNICEF.

    BACKGROUND
  • 1. Mental health of adolescents. (n.d.). Retrieved 20 February 2023, from https://www.who.int/news-room/fact-sheets/detail/adolescent-mental-health

    BACKGROUND

MeSH Terms

Conditions

Phobia, SocialOppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Central Study Contacts

Francisca Alves M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc.

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

September 1, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations