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Clinical Trials/NCT06219057
NCT06219057
Recruiting
N/A

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

University of Coimbra1 site in 1 country30 target enrollmentJune 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Adolescent Behavior
Sponsor
University of Coimbra
Enrollment
30
Locations
1
Primary Endpoint
Other as Shamer Scale - Short Adolescent version
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
August 3, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rita Ramos Miguel

Principal Investigator, Master in clinical psychology

University of Coimbra

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Other as Shamer Scale - Short Adolescent version

Time Frame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

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

Forms of Self-Criticising and Self-Reassuring Scale

Time Frame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

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

Compass of Shame Scale - adolescents version (COSS)

Time Frame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline

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

Secondary Outcomes

  • 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)
  • Achenbach System of Empirically Based Assessment(Baseline, assessment 6-months after baseline; assessment 12-months after baseline)
  • Self-compassion Scale(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)
  • Social Safeness and Pleasure Scale - Adolescent version(Baseline, assessment 6-months after baseline; assessment 12-months after baseline)
  • Kidscreen-10 index(Baseline, assessment 6-months after baseline; assessment 12-months after baseline)
  • Depression, Anxiety and Stress Scale(Baseline, assessment 6-months after baseline; assessment 12-months after baseline)

Study Sites (1)

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