NCT06219057

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

June 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

December 14, 2023

Last Update Submit

January 18, 2024

Conditions

Keywords

child-welfare-based residential carecompassion-focused therapyadolescenceclinical randomized trial

Outcome Measures

Primary Outcomes (3)

  • 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

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

  • 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

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

  • 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

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

Secondary Outcomes (8)

  • Self-compassion Scale

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

  • Compassion Scale

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

  • Fears of Compassion Scales - Adolescents version

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

  • Social Safeness and Pleasure Scale - Adolescent version

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

  • Cognitive Emotion Regulation Questionnaire - Kids version (CERQ)

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

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Group 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.

Behavioral: The Wise Adolescent

Care as Usual

NO INTERVENTION

Group 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.

Interventions

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.

Intervention

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Coimbra, 3000, Portugal

RECRUITING

Related Publications (27)

  • [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

    BACKGROUND
  • [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

    BACKGROUND
  • 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.

    PMID: 26886603BACKGROUND
  • 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.

    PMID: 25649325BACKGROUND
  • [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

    BACKGROUND
  • 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.

    PMID: 26708271BACKGROUND
  • 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.

    PMID: 23209385BACKGROUND
  • 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.

    PMID: 27695145BACKGROUND
  • 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.

    PMID: 26318693BACKGROUND
  • 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.

    PMID: 25196782BACKGROUND
  • 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.

    PMID: 29333987BACKGROUND
  • [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.

    BACKGROUND
  • 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.

    PMID: 28496286BACKGROUND
  • 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.

    PMID: 31366418BACKGROUND
  • 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.

    PMID: 29029675BACKGROUND
  • [16] Gilbert, P., & Procter, S. (2006). Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. Clinical Psychology and Psychotherapy, 13, 353-379. http://dx.doi.org/10.1002/cpp.507

    BACKGROUND
  • [17] Vettese, L.C., Dyer, C.E., Li, W.L., & Wekerle, C. (2011). Does self-compassion mitigate the association between childhood maltreatment and later emotion regulation difficulties? A preliminary investigation. International Journal of Mental Health and Addiction, 9, 480-491. http://dx.doi.org/10.1007/s11469-011-9340-7

    BACKGROUND
  • Zessin U, Dickhauser O, Garbade S. The Relationship Between Self-Compassion and Well-Being: A Meta-Analysis. Appl Psychol Health Well Being. 2015 Nov;7(3):340-64. doi: 10.1111/aphw.12051. Epub 2015 Aug 26.

    PMID: 26311196BACKGROUND
  • Finlay-Jones AL, Rees CS, Kane RT. Self-Compassion, Emotion Regulation and Stress among Australian Psychologists: Testing an Emotion Regulation Model of Self-Compassion Using Structural Equation Modeling. PLoS One. 2015 Jul 24;10(7):e0133481. doi: 10.1371/journal.pone.0133481. eCollection 2015.

    PMID: 26207900BACKGROUND
  • MacBeth A, Gumley A. Exploring compassion: a meta-analysis of the association between self-compassion and psychopathology. Clin Psychol Rev. 2012 Aug;32(6):545-52. doi: 10.1016/j.cpr.2012.06.003. Epub 2012 Jun 23.

    PMID: 22796446BACKGROUND
  • Bluth K, Gaylord SA, Campo RA, Mullarkey MC, Hobbs L. Making Friends With Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for Adolescents. Mindfulness (N Y). 2016 Mar 1;7(2):479-492. doi: 10.1007/s12671-015-0476-6. Epub 2015 Dec 19.

    PMID: 27110301BACKGROUND
  • [22] Carona, C., Rijo, D., Salvador, C., Castilho, P. & Gilbert, P. (2017). Compassion-focused therapy with children and adolescents. BJPsych Advances, 23(4), 240-252. http://dx.doi.org/10.1192/apt.bp.115.015420

    BACKGROUND
  • [23] Ribeiro da Silva, D., Rijo, D., Salekin, R. T., Paulo, M., Miguel, R., & Gilbert, P. (2020). Clinical change in psychopathic traits after the PSYCHOPATHY.COMP program: Preliminary findings of a controlled trial with male detained youth. Journal of Experimental Criminology. https://doi.org/10.1007/s11292-020-09418-x

    BACKGROUND
  • [24] Salvador, C., Carona, C., Catilho, P. & Rijo, D. (2017). Self-criticism and self-compassion in adolescents: Two forms of self-relating and their implications for psychopathology and treatment. Turkiye Klinikleri Child Psychiatry -Special Topics, 3(2):132-8.

    BACKGROUND
  • Jativa R, Cerezo MA. The mediating role of self-compassion in the relationship between victimization and psychological maladjustment in a sample of adolescents. Child Abuse Negl. 2014 Jul;38(7):1180-90. doi: 10.1016/j.chiabu.2014.04.005. Epub 2014 May 5.

    PMID: 24811571BACKGROUND
  • [26] Yarnell, L. M., Stafford, R. E., Neff, K. D., Reilly, E. D., Knox, M. C., & Mullarkey, M. (2015). Meta-analysis of gender differences in self-compassion. Self and Identity, 14(5), 499-520. https://doi.org/10.1080/15298868.2015.1029966

    BACKGROUND
  • Bluth K, Eisenlohr-Moul TA. Response to a mindful self-compassion intervention in teens: A within-person association of mindfulness, self-compassion, and emotional well-being outcomes. J Adolesc. 2017 Jun;57:108-118. doi: 10.1016/j.adolescence.2017.04.001. Epub 2017 Apr 14.

    PMID: 28414965BACKGROUND

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rita Miguel, Master

    University of Coimbra, Portugal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Miguel, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Master in clinical psychology

Study Record Dates

First Submitted

December 14, 2023

First Posted

January 23, 2024

Study Start

June 1, 2023

Primary Completion

February 25, 2024

Study Completion

August 3, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations