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Adolescent BehaviorCFT_RYCNCT06219057

Unfolding the Wisdom Within: CFT for Adolescents in Residential Care

A study testing The Wise Adolescent in people with Adolescent Behavior and Adolescent - Emotional Problem, run by University of Coimbra at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Residential care youth show extensive mental health intervention needs due to history of maltreatment and embedded characteristics of residential placement, leading to harmful and cumulative effects throughout development, linked to internalizing and externalizing difficulties. Read more about this study

Who is it for?
Ages 14 to 18 years
What is being tested?
The Wise Adolescent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePortugal
Study dates
1 Jun 2023to 3 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

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 14 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 1) Being placed in residential care at least for 1-month (allowing for an adjustment period)

Who cannot join

  • Cognitive impairment (assessed through a clinical interview; MINI-KID);
  • Presence of psychotic symptoms or suicidal ideation (according to the MINI-KID).

Trial locations and contacts

1 site in 1 country.

Rita Miguel, Master contact

+351910372759

ritaramosmiguel@gmail.com

Portugal1 site, 1 recruiting

  • Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra

    Coimbra, 3000

    Rita Miguel, +351910372759, ritaramosmiguel@gmail.com

    ritaramosmiguel@gmail.com

    Recruiting

Other trials in Portugal

About this study

Official title: Unfolding the Wisdom Within: A Clinical Trial Assessing the Impact of a Compassion Based Psychotherapeutic Intervention for Adolescents Placed in Child-welfare-based Residential Care

Residential care youth show extensive mental health intervention needs due to history of maltreatment and embedded characteristics of residential placement, leading to harmful and cumulative effects throughout development, linked to internalizing and externalizing difficulties. However, existing interventions show limited suitability and poor randomized effectiveness evaluation.

To overcome these shortcomings, a new compassion-based program for adolescents in residential care will be developed. A non-randomized trial will be run, testing the program´s effects over adolescents' psychological functioning and investigating whether changes in compassion are associated with changes over time in mental health difficulties. The moderator effect of age, gender and maltreatment history will be investigated.

Findings intend to: improve mental-health of youth in residential care, provide an evidence-based intervention to be delivered in residential care settings, increase empirical support of compassion-based interventions, amplifying its scope of delivery.

Read the detailed description

Youth in residential care (YRC) are considered a vulnerable population, presenting higher levels of emotional and behavioural problems than normative peers. YRC exhibit a higher pooled prevalence for any mental disorder (49%) than the general children and adolescent population (13.4%). In Portugal, around 6118 youth are placed in residential care (55% of whom are adolescents), 89% due to history of maltreatment (HM) (neglect and psychological, physical and sexual abuse).

Residential care commonly occurs after a HM which, per se, plays an important role in predicting internalizing (e.g. anxiety, depression), externalizing (e.g. poor impulse control, aggression), and emotion regulation difficulties. HM also contributes to high levels of shame (the affective experience of feeling defective, undesirable) and self-criticism (negative self-evaluations which comprise condemning, attacking and judgemental thoughts directed to the self). Furthermore, although residential care is an attempt to provide protection and care, it frequently represents the loss of attachment figures, repeated moving placements, a less home-like environment and less individualized caregiving. Thus, it is essential that YRC receive interventions that counteract these vulnerabilities. Existing programs address mostly behavioural and cognitive domains, however: a) they are aimed primarily at fostering parental skills of caregivers, not fully meeting adolescents' developmental needs, b) they have limited randomized effectiveness evaluation, and c) findings do not show positive effects on attachment security or placement disruption.

Compassion-based interventions have been gaining growing empirical support in treating several mental health problems and have been shown to be suitable for children, adolescents, and adults. Previous research also demonstrated the benefits of targeting compassion related variables in the treatment of childhood maltreatment survivors, mitigating the association between childhood maltreatment and later emotion regulation difficulties.

Compassion is a motivation comprising a deep awareness regarding the suffering of one-self and others, tied to a wish and effort to relieve it. It is linked to healthy psychological functioning and quality of life. Additionally, compassion negatively predicts emotion regulation difficulties shame and self-criticism, as well as psychopathological problems.

The majority of available findings relates to adult samples, but empirical evidence suggests that compassionate mind training may also be well-timed for adolescents. Within adolescents' studies, compassion has been identified as revealing a buffering effect against psychological distress, partially mediating the relationship between victimization and psychological maladjustment. Differences on gender and age seem to be significant, with males and high school students reporting greater levels of compassion. Intervention studies have also provided support for compassion as a protective factor. Compassion training with adolescents in the community predicted reduction in negative affect, perceived stress, and depressive and anxiety symptoms.

In sum, YRC show wide mental health intervention needs that demand tailored interventions. Since the existing interventions showed limited randomized clinical effectiveness and considering the promising results of compassion based-interventions, the present research aims to broaden the spectrum of therapeutic care, developing and assessing the efficacy of a compassionate-based intervention specifically designed to address the needs from YRC.

Being tested
The Wise Adolescent
Keywords
child-welfare-based residential care, compassion-focused therapy, adolescence, clinical randomized trial
Medical subject headings
Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Wise AdolescentBehavioural

    The program encompasses 20 individual weekly sessions manualized. Its main objective is to help adolescents to create affiliative feelings towards themselves and to develop a more compassionate inner voice. Sessions are organized across 6 main domains: (1) placing ourselves in the challenges of life: evolutionary roots of our mind, how social circumstances and life experiences shape us; the 3-affect regulation systems; (2) understanding difficulties: compassion focused therapy case formulation; (3) understanding compassion: the three flows of compassion, its three pillars (caring commitment, wisdom, strength and courage); (4) compassionate mind training: cultivating the compassion skills (compassionate attention, imagery, reasoning, and behavior); (5) working with difficulties: fears, blocks and resistances to compassion; multiple selves; shame and self-criticism; (6) sustaining a compassionate mind: reviewing the gains and relapse prevention.

Study groups in NCT06219057
Study groupRoleWhat they receive
InterventionExperimentalGroup of adolescents living in residential youth care. Participants selection will take as inclusion criteria: age (between 14 and 18 years old) and being placed in residential care at least for 1-month (allowing for an adjustment period); as exclusion criteria: a) cognitive impairment; b) psychotic symptoms; d) remaining in residential care less than 9-months, considering the study's length. They will be asked to fill in the self-report protocol at 3 different time points (baseline, post-test and 6-month follow-up). Intervention comprises the psychological intervention program "The Wise Adolescent", twenty individual psychotherapeutic sessions based on Compassion Focused Therapy.
Receives: Behavioral: The Wise Adolescent
Care as UsualNo interventionGroup of adolescents living in residential youth care. Participants selection will take as inclusion criteria: age (between 14 and 18 years old) and being placed in residential care at least for 1-month (allowing for an adjustment period); as exclusion criteria: a) cognitive impairment; b) psychotic symptoms; d) remaining in residential care less than 9-months, considering the study's length. They will be asked to fill in the self-report protocol at 3 different time points (baseline, post-test and 6-month follow-up). Participants in the control group will receive care as usual (TAU). There will be no restrictions on the care that can be provided and it may comprise no treatment or, instead, referral to a variety of health care professionals (e.g. psychologist, psychiatrist) with diverse dosage. TAU will be recorded in terms of timing and nature of any intervention received.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Other as Shamer Scale - Short Adolescent version

    The Other as Shamer Scale - Short Adolescent version comprises 8 items combined in one-factor measurement model that assesses a subject's perception of being negatively judged by others (i.e., external shame). Each item is rated on a five-point Likert scale reporting how frequently one experiences the feelings described in each statement (0 = never to 4 = almost always). Cronbach's alphas in the original version were .82 and good concurrent and divergent validity was showed. The Portuguese version reply the short version and presented an internal consistency of .90.

    Vagos, P., Ribeiro da Silva, D., Brazão, N., Rijo, D., \& Gilbert, P. (2016). Dimensionality and measurement invariance of the Other as Shamer Scale across diverse adolescent samples. Personality and Individual Differences, 98, 289-296. http://dx.doi.org/10.1016/j.paid.2016.04.046

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

  2. Forms of Self-Criticising and Self-Reassuring Scale

    The Forms of Self-Criticising and Self-Reassuring Scale is a 22-item scale that measures two forms of self-criticism: (1) inadequate self, which focuses on a sense of personal inadequacy and (2) hated self, which assesses the desire to hurt or persecute the self. The scale also assesses self-reassurance. Items are rated on a five-point Likert scale (ranging from 0 = not at all like me to 4 = extremely like me).The original version of the scale presented good psychometric properties, with alphas of .90 for inadequate self and .86 for hated self and self-reassure. In the Portuguese version, internal consistency values were .89 for inadequate self, .80 for hated self, and .86 for self-reassure.

    Gilbert, P., Clark,M., Hempel, S.,Miles, J. N. V., \& Irons, C. (2004). Criticising and reassuring oneself: An exploration of forms, styles and reasons in female students. British Journal of Clinical Psychology, 43(1), 31-50. https://doi.org/10.1348/014466504772812959

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

  3. Compass of Shame Scale - adolescents version (COSS)

    COSS assesses shame-coping styles. It includes 48 items, distributed over 12 scenarios assessing maladaptive coping styles: (1) Avoidance ( "I act as if it isn't so"); (2) Attack-Self ("I get mad at myself for not being good enough"); (3) Withdrawal ("I withdraw from the activity"); and (4) Attack-Other ("I get irritated with other people"). It also includes 10 items about adaptive responses to a shameful event (e.g., "When I feel lonely or left out, I talk to a friend"). All items in a five-point frequency scale (0 = never to 4 = almost always). The scale showed good and satisfactory internal consistency across all subscales (from α = .72 to α = .88

    Vagos, P., Ribeiro da Silva, D., Brazão, N., Rijo, D., \& Elison, J. (2018). Psychometric properties of the compass of shame scale: Testing for measurement invariance across community boys and boys in foster care and juvenile detentions facilities. Child \& Youth Care Forum, 48(1), 93-110. https://doi.org/10.1007/s10566-018-9474-x

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

Secondary outcomes (8)

  1. Self-compassion Scale

    The Self-compassion Scale addresses self-compassion and instructs participants to answer its 26 self-reported items, rated in a five-point Likert-scale (ranging from 1 = almost never to 5 = almost always), regarding "how I typically act towards myself in difficult times". The scale has a total score and 6 subscales (Self-Kindness; Self-Judgement; Common Humanity; Isolation; Mindfulness; and Over-Identification). In the original version the total score showed very good internal consistency (α = .92) and the six subscales ranged from .75 to .81. In the Portuguese adolescent version, the total score had an internal consistency of .88 and the six subscales ranged from .70 to .79.

    Cunha, M., Xavier, A., \& Castilho, P. (2015). Understanding self-compassion in adolescents: Validation study of the Self-Compassion Scale. Personality and Individual Differences, 93, 56-92. https://doi.org/10.1016/j.paid.2015.09.023

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

  2. Compassion Scale

    The Compassion Scale is a self-report instrument designed to measure compassion for others. This scale has 16 items rated on a 5-point Likert scale (from 1 to 5 points). The adolescent version showed adequacy of a hierarchical-CFA measurement model, with a general score of compassion and four specific factors (i.e., Kindness, Common Humanity, Mindfulness and Indifference). It also showed good internal reliability and construct validity.

    Pommier, E., Neff, K. D. \& Tóth-Király I. (2019). The development and validation of the Compassion Scale. Assessment, 21-39.

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

  3. Fears of Compassion Scales - Adolescents version

    The Fears of Compassion Scales - Adolescents version (FCS-A) assesses fear of compassion for self, fear of compassion for others, and fear of compassion from others. It identifies barriers to giving compassion to oneself (15 items), to others (10 items), and receiving compassion from others (13 items). The items are rated on a five-point Likert scale (0 = don't agree at all to 4 = completely agree). The higher the score, the greater the one's fears, blocks and resistances to compassion. These scales showed good reliability with Cronbach's alpha's of .92 for self, .85 from others, and .84 for others in a student sample.

    Gilbert, P., McEwan, K., Matos, M., Rivis, A. (2011). Fears of compassion: Development of three self-report measures. Psychology and Psychotherapy: Theory, Research and Practice, 84, 239-255. https://doi.org/10.1348/147608310X526511

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

  4. Social Safeness and Pleasure Scale - Adolescent version

    Social Safeness and Pleasure Scale - Adolescent version is a unidimensional self-report questionnaire, composed of 11-items. It assesses how people interpret their social world as safe, soothing and warm (e.g., "I feel a sense of warmth in my relationships with people"). Participants rate each item using a five-point scale (1 = almost never to 5 = almost all the time); so, the total score of SSPS-A range from 11 to 55. In the original study, the SSPS achieved very good internal consistency (α = .91). The adolescent version achieved excelent internal consistency values (α > .93) and evidence for construct validity in relation to external variables was found.

    Miguel, R. R., Sousa, R., Santos, L., Brazão, N., Rijo, D., Castilho, Gilbert, P. (2022). Dimensionality and measurement invariance of the Social Safeness and Pleasure Scale in adolescents from community and residential youth care. Child Abuse and Neglect, 131, 105690. https://doi.org/10.1016/j.chiabu.2022.105690

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

  5. Cognitive Emotion Regulation Questionnaire - Kids version (CERQ)

    CERQ-Kids is a self-report questionnaire assessing cognitive emotional regulation strategies when facing stressful events. Its 36 items are spread across nine subscales: Self-Blame, Rumination, Positive Refocusing, Planning, Other-Blame, Catastrophizing, Putting into Perspective, Positive Reappraisal, and Acceptance. Each subscale has 4 items, answered on a five-point Likert scale that ranges from 1 (almost never) to 5 (almost always). The original version showed Cronbach's alpha ranging between 0.65 and 0.80. The Portuguese version proved to be a psychometrically adequate with alphas ranged between 0.62 and 0.87.

    Moreira, H., Vagos, P., Pereira, J., Fonseca, A., Canavarro, M. C., \& Rijo, D. (2020). Psychometric properties of the Portuguese version of the cognitive emotion regulation questionnaire - kids version (CERQ-kids) among a sample of children and adolescents exposed to wildfires. Currently Psychology, 41, 2574-2585. https://doi.org/10.1007/s12144-020-00778-1

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

  6. Kidscreen-10 index

    Kidscreen-10 is a self-report measure assessing children's perception of their quality of life. It is a 10-item unidimensional questionnaire, answered using a five-point Likert scale that ranges from 1 (never; not at all) to 5 (always; extremely). The original version presented adequate reliability (α = .82) and temporal stability (ICC = .70) and demonstrated good criterion and construct validity. The Portuguese version confirmed the original unidimensional structure and showed adequate reliability (α = .78).

    Matos, M. G., Gaspar, T., \& Simões, C. (2012). Health-related quality of life in Portuguese children and adolescents. Psicologia: Reflexão e Crítica, 25(2), 230-237. https://doi.org/10.1590/S0102- 79722012000200004

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

  7. Depression, Anxiety and Stress Scale

    Depression, Anxiety and Stress Scale is a self-report measure composed by 21 items assessing three dimensions of psychopathological symptoms: depression, anxiety, and stress. Items are rated using a four-point Likert scale for frequency (ranging from 0 = Does not apply to me at all to 3 = Applied to me very much or most of the time). Original version presented good internal consistency values for the three measures (α ≥ .84) as well the Portuguese version (α ≥ .74).

    Lovibond, P., \& Lovibond, H. (1995). The structure of negative emotional states: Comparison of the depression anxiety stress scales (DASS) with Beck depressive and anxiety inventories. Behaviour Research and Therapy, 3, 335-343. https://doi.org/10.1016/0005-7967(94)00075-U

    Salvador, M.C., \& Pires, C. (2020). Depression, Anxiety and Stress Scale: Psychometric properties in a Portuguese adolescent sample. Manuscript in preparation.

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

  8. Achenbach System of Empirically Based Assessment

    Achenbach System of Empirically Based Assessment describe a broad of emotional and behavioral problems in children and adolescents. Multicultural norms have been constructed. Informants rate the problem items as 0 = not true, 1 = somewhat or sometimes true, or 2 = very true or often true, over a period of 6 months.

    Two instruments were administered: (1) Youth self-report (YSR), a psychometric tool that assesses self-reported behavioral and emotional problems and the psychosocial competencies of adolescents between the ages of 11 and 18 years old.

    (2) Child Behavior Checklist (CBCL) was asked to be filled by the caregivers in the care institution.

    Achenbach, T. M. (2009). The Achenbach system of empirically based assessment (ASEBA): Development, findings, theory, and applications. Burlington: University of Vermont, Research Center for Children, Youth, and Families.

    Measured: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start1 Jun 2023
  3. Primary completion25 Feb 2024 (estimated)
  4. Study completion3 Aug 2024 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
To attain this project's aims a longitudinal research will take place. Adolescents living in residential youth care will be invited to participate. According to a criteria of convenience, 15 adolescents will receive the intervention (experimental group) and 15 other adolescents will receive the care as usual (control group).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06219057
Sponsor's protocol ID
2020.05840.BD
Acronym
CFT_RYC
Status last verified
Jan 2024
First submitted
14 Dec 2023
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • [1] Campos, J., Barbosa-Ducharne, M., Dias, P., Rodrigues, S., Martins, A., & Leal, M. (2019). Emotional and behavioral problems and psychosocial skills in adolescents in residential care. Child and Adolescent Social Work Journal, 36, 237-246. https://doi.org/10.1007/s10560-018-0594-9

  • [2] Haggman-Laitila, A., Salokekkila, P., & Karki, S. (2019). Young people's preparedness for adult life and coping after foster care: A systematic review of perceptions and experiences in the transition period. Child & Youth Care Forum, 48, 633-661. https://doi.org/10.1007/s10566-019-09499-4

  • Bronsard G, Alessandrini M, Fond G, Loundou A, Auquier P, Tordjman S, Boyer L. The Prevalence of Mental Disorders Among Children and Adolescents in the Child Welfare System: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2016 Feb;95(7):e2622. doi: 10.1097/MD.0000000000002622.

    PubMed 26886603

  • Polanczyk GV, Salum GA, Sugaya LS, Caye A, Rohde LA. Annual research review: A meta-analysis of the worldwide prevalence of mental disorders in children and adolescents. J Child Psychol Psychiatry. 2015 Mar;56(3):345-65. doi: 10.1111/jcpp.12381. Epub 2015 Feb 3.

    PubMed 25649325

  • [5] Departamento de Desenvolvimento Social. (2019). Casa 2018 - Relatório de caracterização anual da situação de acolhimento das crianças e jovens [Annual report on the characterization of youth in out-of-home placement]. Portugal, Instituto da Segurança Social, I.P. http://www.seg-social.pt/documents/10152/16662972/Relat%C3%B3rio_CASA2018/f2bd8e0a-7e57-4664-ad1e-f1cebcc6498e

  • Li M, D'Arcy C, Meng X. Maltreatment in childhood substantially increases the risk of adult depression and anxiety in prospective cohort studies: systematic review, meta-analysis, and proportional attributable fractions. Psychol Med. 2016 Mar;46(4):717-30. doi: 10.1017/S0033291715002743. Epub 2015 Dec 28.

    PubMed 26708271

  • Norman RE, Byambaa M, De R, Butchart A, Scott J, Vos T. The long-term health consequences of child physical abuse, emotional abuse, and neglect: a systematic review and meta-analysis. PLoS Med. 2012;9(11):e1001349. doi: 10.1371/journal.pmed.1001349. Epub 2012 Nov 27.

    PubMed 23209385

  • Heleniak C, Jenness JL, Stoep AV, McCauley E, McLaughlin KA. Childhood Maltreatment Exposure and Disruptions in Emotion Regulation: A Transdiagnostic Pathway to Adolescent Internalizing and Externalizing Psychopathology. Cognit Ther Res. 2016 Jun;40(3):394-415. doi: 10.1007/s10608-015-9735-z. Epub 2015 Dec 12.

    PubMed 27695145

  • Michl LC, Handley ED, Rogosch F, Cicchetti D, Toth SL. Self-Criticism as a Mechanism Linking Childhood Maltreatment and Maternal Efficacy Beliefs in Low-Income Mothers With and Without Depression. Child Maltreat. 2015 Nov;20(4):291-300. doi: 10.1177/1077559515602095. Epub 2015 Aug 27.

    PubMed 26318693

  • Shahar B, Doron G, Szepsenwol O. Childhood Maltreatment, Shame-Proneness and Self-Criticism in Social Anxiety Disorder: A Sequential Mediational Model. Clin Psychol Psychother. 2015 Nov-Dec;22(6):570-9. doi: 10.1002/cpp.1918. Epub 2014 Sep 5.

    PubMed 25196782

  • Li D, Chng GS, Chu CM. Comparing Long-Term Placement Outcomes of Residential and Family Foster Care: A Meta-Analysis. Trauma Violence Abuse. 2019 Dec;20(5):653-664. doi: 10.1177/1524838017726427. Epub 2017 Aug 31.

    PubMed 29333987

  • [12] Nobre Lima, L. (2009). Estórias e projetos de vida de adolescentes institucionalizados [Stories and life projects from residential care adolescents] (Unpublished doctoral dissertation). (Unpublished doctoral dissertation). Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal.

  • Hambrick EP, Oppenheim-Weller S, N'zi AM, Taussig HN. Mental Health Interventions for Children in Foster Care: A Systematic Review. Child Youth Serv Rev. 2016 Nov;70:65-77. doi: 10.1016/j.childyouth.2016.09.002. Epub 2016 Sep 8.

    PubMed 28496286

  • Schoemaker NK, Wentholt WGM, Goemans A, Vermeer HJ, Juffer F, Alink LRA. A meta-analytic review of parenting interventions in foster care and adoption. Dev Psychopathol. 2020 Aug;32(3):1149-1172. doi: 10.1017/S0954579419000798.

    PubMed 31366418

  • Kirby JN, Tellegen CL, Steindl SR. A Meta-Analysis of Compassion-Based Interventions: Current State of Knowledge and Future Directions. Behav Ther. 2017 Nov;48(6):778-792. doi: 10.1016/j.beth.2017.06.003. Epub 2017 Jun 21.

    PubMed 29029675

Questions about this trial

What is this clinical trial studying?

A study testing The Wise Adolescent in people with Adolescent Behavior and Adolescent - Emotional Problem, 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rita Miguel, Master (+351910372759, ritaramosmiguel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Other as Shamer Scale - Short Adolescent version (time frame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline). 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 NCT06219057, which also lists 27 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 23 Jan 2024.

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