Professional Role Clinical Trial
— CareMEOfficial 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
Verified date | February 2024 |
Source | University of Trás-os-Montes and Alto Douro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | September 30, 2022 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Portugal | University of Trás-os-Montes and Alto Douro | Vila Real |
Lead Sponsor | Collaborator |
---|---|
University of Trás-os-Montes and Alto Douro | Universidade do Porto |
Portugal,
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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.
Bowlby, J. (1988). A secure base: Parent-child attachment and healthy human development. Basic Books.
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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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from Baseline Attachment (Professionals) at T3 (follow up - 19 months) | Participants filled in the Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS, Fraley et al., 2011; Moreira et al., 2015). ECR is 9 item scale composed by attachment-related anxiety (3 items, e.g., "I worry that romantic partners won't care about me as much as I care about them") and avoidance (6 items, e.g., "I prefer not to show a partner how I feel deep down"). Each item was scored on a 7-point Likert scale ranging from strongly disagree to strongly agree. | baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Change from Baseline Exhaustion (Professionals)at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months) | Participants filled in the exhaustion scale from the questionnaire Oldenburg Burnout Inventory OLBI (Demerouti & Bakker, 1999; Sinval et al., 2019). It is composed by 8 items (e.g., "There are days when I feel tired before I arrive at work") scored on a 6-point Likert scale ranging from 1 ("I strongly disagree "to 6 ("I strongly agree"). | baseline | |
Secondary | Change from Baseline Mental health (Professionals) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months) | Participants filled in the well-being (4 items; e.g., "I have felt OK about myself"), Symptoms (12 items, e.g.," I have felt tense, anxious or nervous") and Functioning scales (12 items, e.g., "I have been happy with the things I have done") from the Clinical Outcome Routine Evaluation - no risk (CORE-NR; Sales et al., 2012), rated on a 5-point Likert scale from 1("never") to 5 ("always or almost always"). | baseline | |
Secondary | Change from Baseline Quality of relationship with Professional Caregivers (Adolescents)at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months) | Participants filled in the professional caregiver's subscale from Connection Questionnaire to Staff and Teachers (QLFP) - (Mota & Matos, 2005). This subscale aggregates 14 items (14 items, e.g., I feel close to some careworkers of the residential care setting I live in), rated on a 6-point Likert-Scale, from (1) "Strongly Disagree" through (6) "Strongly Agree". | baseline | |
Secondary | Change from Baseline Hope (Adolescents) at T2 (13 months) and T3 (follow up - 19 months) | Participants filled in the hope scale from Vision About Future (Ginevra et al., 2017; Nunes, et al., 2018). It consists of 10 items (e.g., I feel that I will get along quite well.), rated on 5-point Likert-scale from 1 (does not describe me at all) to 5 (describes me very well). | baseline | |
Secondary | Change from Baseline Psychological adjustment problems (Adolescents) at T1 (seven months), T2 (13 months) and T3 (follow up - 19 months) | Participants filled in the Reynolds Adolescent Adjustment Screening Inventory (RAASI, Reynolds, 2001, Calheiros et al., 2009). RAASI is 32 items scale that evaluates 4 dimensions Antisocial Behavior (5 items, e.g., "I did things that were against the law"), Anger control problems (11 items "I felt angry"), Emotional distress (10 items e.g., "I worried a lot about the future"), and Positive self (6 items e.g., "I felt good about myself") rated on a 3-point Likert scale, from 1 (never or almost never) to 3 (always or almost always). | baseline | |
Secondary | Change from Baseline Self-efficacy (Adolescents) at T2 (13 months) and T3 (follow up - 19 months) | Participants filled in the General Self-Efficacy Scale (GSE, Jerusalem & Schwarzer, 1981; Araújo & Moura, 2011). GSE is a 10-item scale that evaluates self-efficacy (e.g., I can always manage to solve difficult if I try hard enough"). Rated on a 4-point Likert scale, from 1 (not all true) to 3 (exactly true). | baseline | |
Secondary | Change from Baseline Emotion regulation (Adolescents) at T2 (13 months) and T3 (follow up - 19 months) | Participants filled in the scales "do not hide emotions" (e.g., When I am angry or upset' I try to hide this) and "differentiating emotions" (e.g., When I am upset' I don´t know if I am sad' scared or angry) the Emotion Awareness Questionnaire (EAQ) (Rieffe et al., 2007; Veiga, et al., 2017), rated on a 3 point Likert scale from 1 (Not true) to 3 (True). | baseline | |
Secondary | Change from Baseline Satisfaction with residential setting (Adolescents) at T2 (13 months) and T3 (follow up - 19 months) | Participants filled in the Caregiving Environment Satisfaction Questionnaire (McDowall, 2013, adapted by Santos et al., 2019). The scale is composed by 7 items (e.g., "I have the privacy I need") rated on a 4-point Likert scale, from (1) Strongly Disagree to (4) Strongly Agree. | baseline | |
Secondary | Change from Baseline Attachment (Adolescents) at T1 (seven months) and T2 (13 months) | Participants filled in the Vulnerable Attachment Style Questionnaire (VASQ) (Bifulco, et al. 2003, Santos et al., 2019). VASQ is a 22-item scale that evaluates Insecurity (12 items, e.g., It's best not to get too emotionally close to other people) and Proximity-Seeking (10 items, e.g., I rely on others to help me make decisions), rated on a 5-point Likert Scale, from (1) "Strongly Disagree" through (5) "Strongly Agree". | baseline |
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