Clinical trial NCT05600439: Efficacy of an Attachment-based Intervention in Residential Care (CareME)
Official title: CareME - Efficacy of an Attachment-based Intervention in Residential Care: A Randomized Controlled Trial on the Effects on the Caregivers' Relational Skills and the Adolescents' Psychosocial Adaptation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Professional Role
Keywords: Attachment, Caregiving, Professionals, Youth
Lead sponsor: University of Trás-os-Montes and Alto Douro
Sponsor class: OTHER
Collaborators: name: Universidade do Porto
First posted: 2022-10-31
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: CareME is a group attachment-based intervention program developed for improving relational abilities in professional caregivers working in Youth Residential Care (YRC) settings. The intervention program was planned to integrate 12 group session (90 minutes each), implemented fortnightly during a 6-month period, and facilitated by two psychologists and expertise researchers on attachment framework.

The project aims to produce effects on professional caregivers' behaviors and, as an indirect effect, to produce changes on adolescents' outcomes (age 12 to 18 years old).

Regarding professional caregivers' behaviors the project aims to improve reflective functioning, perspective taking, emotion regulation, group intervention practices and quality of relationships in RC (primary outcomes). Additionally, it's expected to reduce levels of professional exhaustion and improve mental health (secondary outcomes). Attachment was considered a moderator. As a result of professional's caregivers behavior change, it is expected to observe subsequent effects on adolescents' psychosocial adaptation indicators, such as improvements on the quality of relationship with professional caregivers, hope, self-efficacy and in emotional regulations processes and a decrease on antisocial behavior, anger control problems and emotional suffering (secondary outcomes). Attachment was considered also a moderator.

Program efficacy was evaluated using a randomized control trial (RCT). Institutions were assigned to the experimental (n = 10) and to the control (n = 11) group using a covariate adaptative randomization method. Data was assessed using a 4-wave longitudinal design (baseline, interim, post, 6-month follow-up) with professional caregivers and adolescents' self-reports.

Detailed description: CareME is a group attachment-based intervention program developed for improving relational abilities in professional caregivers working in Youth Residential Care (YRC) settings. The intervention program was planned to integrate 12 group session (90 minutes each), implemented fortnightly during a 6-month period, and facilitated by two psychologists and expertise researchers on attachment framework.

Aim CareME highlights the role of relational dynamics with significant figures from the residential care context - the caregivers - as enablers of resilient processes and the adaptive development of young people in face of adversity trajectories. More specifically CareME intends to improve the quality of care provided by professional caregivers, by enhancing relational skills directly associated with sensitive care such as emotional regulation and mentalization and improve caregiving behaviors such as emotional support and autonomy granting. It is also expected that changes on professional relational abilities would have a subsequent effect on adolescents' behavioral problems and socioemotional adaptation dimensions.

The elaboration of the intervention was clearly theoretically grounded, based on J. Bowlby and M. Ainsworth's attachment theory, focusing on the development of secure relationships as protective factors against risk. In this sense, the intervention is framed on the crucial role that these professionals have on providing the emotional secure environment for adolescent's psychosocial adaptation and development, minimizing risk and preventing psychopathology. As in other attachment-based intervention programs relational processes intrinsically associated with attachment dimensions, emotional regulation and mentalization were particularly intentionalized during intervention.

More specifically, the project aims to produce effects on professional caregivers' behaviors and, as an indirect effect, to produce changes on adolescents' outcomes (age 12 to 18 years old). Regarding professional caregivers' behaviors, the project aims to improve reflective functioning, perspective taking, emotion regulation, group intervention practices and quality of relationships in RC. Additionally, it's expected to reduce levels of professional exhaustion, improve mental health. Attachment was considered a moderator. As a result of a professional's caregiver's behavior change, it is expected to observe indirect effects on adolescents' psychosocial adaptation indicators, such as improvements in the quality of relationship with professional caregivers, hope, and self-efficacy and in emotional regulations processes and a decrease on antisocial behavior, anger control problems and emotional suffering (secondary outcomes). Attachment was considered also a moderator.

The intervention was programmed to be conducted in person in the Faculty of Psychology and Sciences of Education from the University of Porto facilities. Nevertheless, there were important changes that were introduced to what was initially programmed. The program periodicity, duration, and number of sessions, were changed due to unpredicted challenges introduced by the 1st wave of the pandemic (March 2020). The first 3 sessions (February/March 2020) were conducted fortnightly in person as planned. Then, there was a 7-month period of interruption due to the abrupt changes introduced by the pandemic. The program restarted in October 2020 online on a weekly basis (7 sessions) ending in December 2020. The interruption period resulted from the implications of lockdown measures on YRC organization, and the need to respond to most pressing needs regarding management (e.g., prevent youth and staff contamination, ensure continued responses to other healthcare and psychological intervention needs, ensure communication between youth and most significative ones as family/other relatives/friends, and ensure conditions for distance education). All sessions were then discussed and evaluated according to the project intervention plan and attachment framework. Sessions were supervised by two expert researchers on psychological intervention implementation.

The project was approved by the Ethical Committee of the Faculty of Psychology and Sciences of Education from the University of Porto and the University of Trás-os-Montes and Alto Douro, Portugal.

Procedure: The project was presented to all YRC managers (directors) from Porto district and a total of 21 from the 24 juvenile residential care facilities from Porto district agreed to participate. The dissemination process was facilitated by the National Social Protection sector from Porto District.

Considering the great variation in YRC facilities assigned to the study, randomization was conducted using a covariate adaptative randomization method. YRC facilities were distributed by the experimental (n = 10) and control (n =11) groups according to the minimization method balancing allocation by house facilities (homes vs institution), house typology (gender-specific and mixed), child to caregiver ratio and a number of caregivers. The sample included a total of 212 professional caregivers aiming to integrate the CareME intervention project (Experimental group = 110 professionals) and Control group = 106). A total of 5 groups were created (n \< 25 individuals), integrating elements from multiple YRC from the experimental group. Considering that in most institutions' professional caregivers from the technical staff group have management and hierarchical positions towards the educative group, people were also assigned to each group considering the professional role they have in the institution (technical or educative group).

Data Collection was conducted using a 4-wave longitudinal design (baseline - T0, interim -T1 (seven months), post -T2 (13 months) and follow-up-T3 (19 months), using professional caregivers and adolescents' self-reports. Initially, all data collection was planned to be conducted in person in YRC facilities with the supervision and support from 2 researchers. Due to the pandemic, only the 1st wave/baseline was conducted presential. The first wave (baseline) was conducted from November 2019 to January 2020; the 2nd wave (interim), was conducted from June to September 2020, mainly for capturing/controlling the effects of the pandemic; the 3rd wave was conducted between December 2020 and March 2021. The 4th wave (6-month follow-up) was conducted between July and October 2021.

The general objectives of the study were presented in each administration and standardized instructions were given regarding the assessment procedure. After their written informed consent/assent, data collection was conducted. Participation was voluntary and anonymous, and no financial compensation was involved. During the first wave/baseline, two researchers were available to support data collection and ensure confidentiality/anonymity. Afterward, when necessary, online support was given for supporting data collection.

The control group didn´t have any additional intervention assigned.

Eligibility criteria: Inclusion Criteria:

* Professionals from the educative and technical team working in YRC settings from the selected facilities
* Professionals that work with children age ranging 12 and 18 years old.

Exclusion Criteria:

- RC facilities that didn´t sign up at least 70% of professional caregivers (both from the technical and educative team)

For adolescents:

Inclusion Criteria:

* Adolescents currently in YRC facilities
* Adolescents with ages ranging between 12 and 18 years old at the 1st data collection.

Exclusion Criteria:

- Adolescents with severe cognitive or emotional impairment

Primary outcomes:
measure: Change from Baseline Reflexive functioning (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Perspective Taking (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Group intervention practices (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Quality of relationships with YRC (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Emotion Regulation (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
Secondary outcomes:
measure: Change from Baseline Exhaustion (Professionals)at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Mental health (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Quality of relationship with Professional Caregivers (Adolescents)at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Hope (Adolescents) at T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Psychological adjustment problems (Adolescents) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Self-efficacy (Adolescents) at T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Emotion regulation (Adolescents) at T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Satisfaction with residential setting (Adolescents) at T2 (13 months) and T3 (follow up - 19 months)
timeFrame: baseline
measure: Change from Baseline Attachment (Adolescents) at T1 (seven months) and T2 (13 months)
timeFrame: baseline
Other outcomes:
measure: Change from Baseline Attachment (Professionals) at T3 (follow up - 19 months)
timeFrame: baseline
Locations:
city: Vila Real
country: Portugal
facility: University of Trás-os-Montes and Alto Douro
Study officials:
affiliation: University of Trás-os-Montes and Alto Douro
name: Catarina P Mota, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ainsworth, M. S., & Bowlby, J. (1991). An ethological approach to personality development. American psychologist, 46(4), 333.
citation: Bowlby, J. (1973). Attachment and loss: Volume II: Separation, anxiety and anger. In Attachment and loss: Volume II: Separation, anxiety and anger (pp. 1-429). The Hogarth press and the institute of psycho-analysis.
citation: Bowlby, J. (1988). A secure base: Parent-child attachment and healthy human development. Basic Books.
citation: Fonagy, P., Gergely, G., Jurist, E. L., & Target, M. (2018). Affect regulation, mentalization, and the development of the self. Routledge.
citation: Moretti MM, Obsuth I, Craig SG, Bartolo T. An attachment-based intervention for parents of adolescents at risk: mechanisms of change. Attach Hum Dev. 2015;17(2):119-35. doi: 10.1080/14616734.2015.1006383. Epub 2015 Mar 18.
citation: Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
citation: Törrönen, M. (2021). Social relationships and their connection to mental health for young people who have been in the care system. The British Journal of Social Work, 51. https://doi.org/10.1093/bjsw/bcab028
citation: Zegers MA, Schuengel C, Van IJzendoorn MH, Janssens JM. Attachment and problem behavior of adolescents during residential treatment. Attach Hum Dev. 2008 Mar;10(1):91-103. doi: 10.1080/14616730701868621.
citation: Costa M, Matos PM, Santos B, Carvalho H, Ferreira T, Mota CP. We stick together! COVID-19 and psychological adjustment in youth residential care. Child Abuse Negl. 2022 Aug;130(Pt 1):105370. doi: 10.1016/j.chiabu.2021.105370. Epub 2021 Oct 18.