NCT05600439

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

September 30, 2022

Last Update Submit

February 9, 2024

Conditions

Keywords

Attachment, Caregiving, Professionals, Youth

Outcome Measures

Primary Outcomes (5)

  • Change from Baseline Reflexive functioning (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)

    Participants filled in the Reflective Functioning Questionnaire (RFQ, Fonagy et al., 2016; Neto et al, xxx), for assessing certainty (4 items, e.g., "I don't always know why I do what I do") and uncertainty (4 items, e.g., "I always know what I feel.") regarding self and other mental states. Items are rated using 7-point Likert scale from 1 ("Strongly disagree") to 4 ("Strongly agree") .

    baseline

  • Change from Baseline Perspective Taking (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)

    Participants filled in the perspective taking scale from Interpersonal Reactivity Index (IRI; Davis, 1980, 1983; Limpo et al., 2010). It consists of 7 items (e.g., Sometimes I have a hard time seeing things from the young people's point of view), rated on 5-point Likert-scale from 1 (does not describe me at all) to 5 (describes me very well).

    baseline

  • Change from Baseline Group intervention practices (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)

    Participants filled in Group Care Worker Intervention Checklist - GICL (Bastiaanssen et al., 2012; Santos et al., 2019) for assessing support (6 items, e.g., "Offering individual attention") autonomy (7 items, e.g., "Promote social independence") and control (8 items, e.g., "Learning to obey") rated on 3-point Likert scale from 1 ("not true") to 3 ("true").

    baseline

  • Change from Baseline Quality of relationships with YRC (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)

    Quality of relationships with YRC (Mota \& Matos, 2010 adapted) was used for assessing "Caregiver as a Support figure" (6 items, e.g., "I feel youngsters trust me") and "Fear of merging boundaries" (9 items, e.g., "I feel I give more that I should") rated on a 6 point Likert scale from 1 ("I completely disagree") to 6 ("I completely agree").

    baseline

  • Change from Baseline Emotion Regulation (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)

    Participants filled in the Affect Regulation Checklist (ARC; Moretti, 2003; Santos et al, submitted). ARC is a 12 items questionnaire that evaluates 3 dimensions: suppression (4 items, e.g., "I try hard not to think about my feelings"), dysregulation (4 items, "My feelings just take over me and I can't do anything about it"), and adaptive reflection (4 items, "Thinking about why I have different feelings helps me to learn about myself"). Items are rated in a 5-point Likert scale ranging from 1 ("Not like me") to 5 ("A lot like me").

    baseline

Secondary Outcomes (9)

  • Change from Baseline Exhaustion (Professionals)at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)

    baseline

  • Change from Baseline Mental health (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)

    baseline

  • Change from Baseline Quality of relationship with Professional Caregivers (Adolescents)at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)

    baseline

  • Change from Baseline Hope (Adolescents) at T2 (13 months) and T3 (follow up - 19 months)

    baseline

  • Change from Baseline Psychological adjustment problems (Adolescents) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months)

    baseline

  • +4 more secondary outcomes

Other Outcomes (1)

  • Change from Baseline Attachment (Professionals) at T3 (follow up - 19 months)

    baseline

Study Arms (2)

Experimental GP

EXPERIMENTAL

CareME Program. Group attachment-based intervention program developed for improving relational abilities in professional caregivers working in Youth Residential Care (YRC) settings.

Behavioral: CareME

Control GP

NO INTERVENTION

The control group had no intervention assigned.

Interventions

CareMEBEHAVIORAL

CareME program was planned to integrate 12 group session (90 minutes), implemented fortnightly during a 6-month period, and facilitated by two psychologists and expert researchers on attachment framework. Components included psychoeducation (description of core concepts such as attachment, secure base, safe haven, emotion regulation, mentalization, trauma, and discussion of research on professional caregiving in YRC); experiential and relational exercises (roleplay; cases discussion, film script discussion). The program has 7 moduli: (i) adolescents' "pain-based behaviors" and attachment theoretical lens; (ii) adolescence and main developmental challenges (iii) setting rules and limits; (iv) trust \& secure base (figures and environment); (v) professionals' stories of attachment \& caregiving (vi) personal and structural characteristics that prevent a secure caregiving environment and (vii) professional impairment and strategies promoting healthy secure base provision.

Experimental GP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- RC facilities that didn´t sign up at least 70% of professional caregivers (both from the technical and educative team)
  • For adolescents:
  • Adolescents currently in YRC facilities
  • Adolescents with ages ranging between 12 and 18 years old at the 1st data collection.
  • \- Adolescents with severe cognitive or emotional impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Trás-os-Montes and Alto Douro

Vila Real, Portugal

Location

Related Publications (9)

  • Ainsworth, M. S., & Bowlby, J. (1991). An ethological approach to personality development. American psychologist, 46(4), 333.

    BACKGROUND
  • 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.

    BACKGROUND
  • Bowlby, J. (1988). A secure base: Parent-child attachment and healthy human development. Basic Books.

    BACKGROUND
  • Fonagy, P., Gergely, G., Jurist, E. L., & Target, M. (2018). Affect regulation, mentalization, and the development of the self. Routledge.

    BACKGROUND
  • 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.

    PMID: 25782460BACKGROUND
  • 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.

    PMID: 21772732BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 18351496BACKGROUND
  • 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.

Related Links

Study Officials

  • Catarina P Mota, PhD

    University of Trás-os-Montes and Alto Douro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 31, 2022

Study Start

October 1, 2018

Primary Completion

January 31, 2020

Study Completion

September 30, 2022

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
After project completion.
Access Criteria
Use for research purposes.

Locations