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Acceptance and Commitment Group Therapy for Unaccompanied Minors

Primary Purpose

Post Traumatic Stress Disorder, Depression, Anxiety Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
University of Cyprus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Unaccompanied Refugee Minors, Acceptance and Commitment Therapy, Child/Adolescent Mental Health, Quality of Life

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Unaccompanied refugee minors living in sheltered accommodation in Cyprus.
  • No specific diagnosis required to take part in the study.
  • No specific cultural background required.
  • Minors who provide consent.

Exclusion Criteria:

- Presence of active psychosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    ACT Intervention

    Control group

    Arm Description

    5-week ACT Group Intervention based on the Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide".

    Waiting-list

    Outcomes

    Primary Outcome Measures

    Change in 'Quality of Life': KIDSCREEN-27 (Ravens-Sieberer et al., 2007).
    This is a 27-item instrument that consists of five dimensions of quality of life: physical well-being (5 items), psychological well-being (7 items), autonomy and relationship with parents (7 items), peers and social support (4 items), and school environment (4 items). The questions concern the last seven days and answers are given on a five-point Likert scale ('Not at all, slightly, moderately, very, extremely' or 'never, seldom, quite often, very often, always'). Higher scores on the KIDSCREEN-27 reflect higher quality of life and wellbeing. Internal consistency of this scale was considered satisfactory (Cronbach's alpha= >.70).
    Change in 'The Depression, Anxiety and Stress Scale' (DASS-21; Lovibond & Lovibond, 1995; Antony, Bieling, Cox, Enns, & Swinson., 1998).
    This scale includes 21 items and will be used to assess for symptoms of depression, anxiety and stress in our sample. The Depression scale assesses hopelessness, low self-esteem, and low positive affect. The Anxiety scale assesses autonomic arousal, physiological hyperarousal, and the subjective feeling of fear. The Stress scale items assess tension, agitation, and negative affect. There are seven items per scale and participants must rate their past week on a Likert-type scale (0-3). Higher scores indicate higher levels of depression, stress and anxiety. Cronbach's alphas indicating high internal consistency for Depression .94, Anxiety .84 and Stress .91.
    Change in 'The Child Revised Impact of Events Scale' (CRIES-8; Perrin, Meiser-Stedman, & Smith., 2005).
    This scale will be used to assess for any post-traumatic stress symptoms. The total number of items in the scale are 8 items. Four of the items assess intrusion (intrusive thoughts, feelings) and the remaining four items assess avoidance (avoidance of situations, feelings). The items are scored on a 4- point scale, where higher scores indicate higher levels of intrusion or avoidance. The CRIES-13 (Smith, Perrin, Dyregov, & Yule, 2003) was found to have high internal consistency (Cronbach's alpha= 0.80). Sensitivity (i.e., the probability that someone with a diagnosis of PTSD will screen positive) was found to be .94-1.0. Specificity (i.e., the probability that someone without a diagnosis of PTSD will screen negative) was found to be .59-.71. The overall efficiency rate of the CRIES-8 is 75-82.7%.
    Change in 'Strengths and Difficulties Questionnaire' (SDQ; Goodman, 1997; 2001).
    This questionnaire consists of 25 items divided into five subscales with 5 items each: Emotional difficulties, Conduct problems, Hyperactivity/inattention, Peer problems and Prosocial behaviour. Each item is scored on a 3-point scale (0= 'not true', 1='somewhat true', and 2= 'certainly true'). Subscale scores are calculated by summing scores on relevant items (after recoding reversed items). Higher scores on the prosocial behaviour subscale indicate strengths, whilst higher scores on the other four subscales indicate difficulties. A total difficulties score is computed by summing the scores on all five subscales (range 0-40). Reliability of this scale is satisfactory as assessed by internal consistency (Cronbach's alpha=0.73), cross-informant correlation (mean= 0.34), and retest stability after 4 to 6 months (mean= 0.62).

    Secondary Outcome Measures

    Change in the ACT Process Measure: PsyFlex (Gloster et al., 2021).
    This is an 8-item self-report questionnaire which assesses the process of psychological flexibility. Each item is rated on a five-point scale from 1 (very often) to 5 (very rarely).

    Full Information

    First Posted
    December 10, 2021
    Last Updated
    January 19, 2022
    Sponsor
    University of Cyprus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05218031
    Brief Title
    Acceptance and Commitment Group Therapy for Unaccompanied Minors
    Official Title
    Acceptance and Commitment Group Therapy for Unaccompanied Minors: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    December 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Cyprus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Unaccompanied minors (UM) are considered to be a highly vulnerable refugee subgroup. Research has indicated that UM experience traumatic events and consequently develop high levels of psychopathology. Post-traumatic stress disorder is the most prevalent diagnosis, followed by depression, anxiety disorders as well as traumatic grief and conduct problems. Acceptance and Commitment Therapy (ACT) may be particularly suited to the treatment of survivors of trauma and with vulnerable refugee groups such as UM. A 5-week ACT group intervention will be carried out and its feasibility in UM will be explored along with its effect on mental health. The ACT group intervention will be based on a Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide". Following the 5-week ACT group intervention, focus groups with participants will be carried out to examine its acceptability and will be analysed qualitatively, using thematic analysis.
    Detailed Description
    The hypotheses of the study are as follows: The ACT group intervention will lead to increases in UM psychological well-being and quality of life compared to a waiting-list (WL) control group. This includes improvements in post-traumatic stress symptoms, depression, anxiety, stress, and sleep difficulties. (Primary outcomes). The UM receiving the ACT group intervention will demonstrate improvements in their prosocial behaviour compared to the WL control group. (Primary outcomes). At post-intervention, UM receiving the ACT group intervention will have enhanced psychological flexibility compared to the WL control group. It is predicted that there will be decreased experiential avoidance and cognitive fusion, coupled with increases in values-driven committed action, present moment awareness and self-as-context. (Secondary outcomes). At the 1-month and 3-month follow-up time points, the UM receiving the ACT group intervention will have retained the improvements from the treatment (i.e., increased psychological wellbeing, enhanced psychological flexibility, augmented prosocial behaviour) compared to the WL control group. Additionally, it is predicted that UM who completed the ACT group intervention will not only have sustained the benefits observed directly post-intervention but will in fact keep making progress at follow-up time points compared to the WL control group. From the qualitative analysis, the investigators presume to provide critical insights as to what is perceived acceptable and culturally appropriate treatment for this population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Traumatic Stress Disorder, Depression, Anxiety Disorders
    Keywords
    Unaccompanied Refugee Minors, Acceptance and Commitment Therapy, Child/Adolescent Mental Health, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A two-arm randomised trial will be conducted (brief ACT-based intervention vs. waiting-list control group)
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ACT Intervention
    Arm Type
    Experimental
    Arm Description
    5-week ACT Group Intervention based on the Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide".
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Waiting-list
    Intervention Type
    Behavioral
    Intervention Name(s)
    Acceptance and Commitment Therapy
    Intervention Description
    A 90-120 minute 5-week group intervention for unaccompanied minors. Each week there will be a different focus. Week 1: Grounding, Week 2: Unhooking, Week 3: Values, Week 4: Self-compassion, Week 5: Making room for unwanted thoughts and feelings.
    Primary Outcome Measure Information:
    Title
    Change in 'Quality of Life': KIDSCREEN-27 (Ravens-Sieberer et al., 2007).
    Description
    This is a 27-item instrument that consists of five dimensions of quality of life: physical well-being (5 items), psychological well-being (7 items), autonomy and relationship with parents (7 items), peers and social support (4 items), and school environment (4 items). The questions concern the last seven days and answers are given on a five-point Likert scale ('Not at all, slightly, moderately, very, extremely' or 'never, seldom, quite often, very often, always'). Higher scores on the KIDSCREEN-27 reflect higher quality of life and wellbeing. Internal consistency of this scale was considered satisfactory (Cronbach's alpha= >.70).
    Time Frame
    Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
    Title
    Change in 'The Depression, Anxiety and Stress Scale' (DASS-21; Lovibond & Lovibond, 1995; Antony, Bieling, Cox, Enns, & Swinson., 1998).
    Description
    This scale includes 21 items and will be used to assess for symptoms of depression, anxiety and stress in our sample. The Depression scale assesses hopelessness, low self-esteem, and low positive affect. The Anxiety scale assesses autonomic arousal, physiological hyperarousal, and the subjective feeling of fear. The Stress scale items assess tension, agitation, and negative affect. There are seven items per scale and participants must rate their past week on a Likert-type scale (0-3). Higher scores indicate higher levels of depression, stress and anxiety. Cronbach's alphas indicating high internal consistency for Depression .94, Anxiety .84 and Stress .91.
    Time Frame
    Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
    Title
    Change in 'The Child Revised Impact of Events Scale' (CRIES-8; Perrin, Meiser-Stedman, & Smith., 2005).
    Description
    This scale will be used to assess for any post-traumatic stress symptoms. The total number of items in the scale are 8 items. Four of the items assess intrusion (intrusive thoughts, feelings) and the remaining four items assess avoidance (avoidance of situations, feelings). The items are scored on a 4- point scale, where higher scores indicate higher levels of intrusion or avoidance. The CRIES-13 (Smith, Perrin, Dyregov, & Yule, 2003) was found to have high internal consistency (Cronbach's alpha= 0.80). Sensitivity (i.e., the probability that someone with a diagnosis of PTSD will screen positive) was found to be .94-1.0. Specificity (i.e., the probability that someone without a diagnosis of PTSD will screen negative) was found to be .59-.71. The overall efficiency rate of the CRIES-8 is 75-82.7%.
    Time Frame
    Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
    Title
    Change in 'Strengths and Difficulties Questionnaire' (SDQ; Goodman, 1997; 2001).
    Description
    This questionnaire consists of 25 items divided into five subscales with 5 items each: Emotional difficulties, Conduct problems, Hyperactivity/inattention, Peer problems and Prosocial behaviour. Each item is scored on a 3-point scale (0= 'not true', 1='somewhat true', and 2= 'certainly true'). Subscale scores are calculated by summing scores on relevant items (after recoding reversed items). Higher scores on the prosocial behaviour subscale indicate strengths, whilst higher scores on the other four subscales indicate difficulties. A total difficulties score is computed by summing the scores on all five subscales (range 0-40). Reliability of this scale is satisfactory as assessed by internal consistency (Cronbach's alpha=0.73), cross-informant correlation (mean= 0.34), and retest stability after 4 to 6 months (mean= 0.62).
    Time Frame
    Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
    Secondary Outcome Measure Information:
    Title
    Change in the ACT Process Measure: PsyFlex (Gloster et al., 2021).
    Description
    This is an 8-item self-report questionnaire which assesses the process of psychological flexibility. Each item is rated on a five-point scale from 1 (very often) to 5 (very rarely).
    Time Frame
    Pre-intervention, throughout study completion 5 weeks, 1-month follow-up, 3-months follow-up
    Other Pre-specified Outcome Measures:
    Title
    Treatment Adherence Measure: ACT Fidelity Measure (ACT-FM; O'Neill et al., 2019).
    Description
    This questionnaire consists of 25 items which capture four key areas within ACT: Therapist Stance (7 items), Open Response Style (6 items), Aware Response Style (6 items) and Engaged Response Style (6 items). Within each area there are items to score the therapist's behaviour as ACT consistent and ACT inconsistent. Scoring is rated on a 4-point scale from 0-3 (0= 'This behaviour never occurred', 1= 'Therapist rarely enacts this behaviour', 2= 'Therapist sometimes enacts this behaviour', 3= 'Therapist consistently enacts this behaviour'). Within 'Engaged response style' for instance, "Therapist gives the client opportunities to clarify their own values" would be considered ACT consistent, "Therapist imposes their own, other's or society's values upon the client" would be considered ACT inconsistent. A total score can be calculated for each subscale as well as a total ACT consistent score and total ACT inconsistent score. Inter-rater reliability was deemed moderate to excellent.
    Time Frame
    up to 5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Unaccompanied refugee minors living in sheltered accommodation in Cyprus. No specific diagnosis required to take part in the study. No specific cultural background required. Minors who provide consent. Exclusion Criteria: - Presence of active psychosis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria Karekla, Ph.D.
    Phone
    0035722892100
    Email
    mkarekla@ucy.ac.cy
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dafne Morroni, MSc
    Phone
    0035799798913
    Email
    dmorro01@ucy.ac.cy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Karekla, Ph.D.
    Organizational Affiliation
    University of Cyprus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://www.ucy.ac.cy/acthealthy/en/
    Description
    University Clinical Laboratory Website

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