Clinical trial NCT06219057: Unfolding the Wisdom Within: CFT for Adolescents in Residential Care
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Behavior
Adolescent - Emotional Problem
Keywords: child-welfare-based residential care
compassion-focused therapy
adolescence
clinical randomized trial
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Other as Shamer Scale - Short Adolescent version
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
measure: Forms of Self-Criticising and Self-Reassuring Scale
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
measure: Compass of Shame Scale - adolescents version (COSS)
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
Secondary outcomes:
measure: Self-compassion Scale
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
measure: Compassion Scale
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
measure: Fears of Compassion Scales - Adolescents version
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
measure: Social Safeness and Pleasure Scale - Adolescent version
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
measure: Cognitive Emotion Regulation Questionnaire - Kids version (CERQ)
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
measure: Kidscreen-10 index
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
measure: Depression, Anxiety and Stress Scale
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
measure: Achenbach System of Empirically Based Assessment
timeFrame: Baseline, assessment 6-months after baseline; assessment 12-months after baseline
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra
Study officials:
affiliation: University of Coimbra, Portugal
name: Rita Miguel, Master
role: PRINCIPAL_INVESTIGATOR
References:
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