Acceptance and Commitment Group Therapy for Unaccompanied Minors

NCT05218031 | Unknown DMC

• 1 other identifier: K3_K1_1
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Traumatic Stress Disorder; Depression; Anxiety Disorders

Keywords

Unaccompanied Refugee Minors; Acceptance and Commitment Therapy; Child/Adolescent Mental Health; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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).

  Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up

• 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.

  Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up

• 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%.

  Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up

• 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).

  Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up

Secondary Outcomes (1)

• Change in the ACT Process Measure: PsyFlex (Gloster et al., 2021).

  Pre-intervention, throughout study completion 5 weeks, 1-month follow-up, 3-months follow-up

Other Outcomes (1)

• Treatment Adherence Measure: ACT Fidelity Measure (ACT-FM; O'Neill et al., 2019).

  up to 5 weeks

Study Arms (2)

ACT Intervention

EXPERIMENTAL

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".

Behavioral: Acceptance and Commitment Therapy

Control group

NO INTERVENTION

Waiting-list

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

ACT Intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- Presence of active psychosis.

Sponsors & Collaborators

• University of Cyprus: lead

Related Links

• University Clinical Laboratory Website

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maria Karekla, Ph.D.

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Karekla, Ph.D.

CONTACT

0035722892100; mkarekla@ucy.ac.cy

Dafne Morroni, MSc

CONTACT

0035799798913; dmorro01@ucy.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A two-arm randomised trial will be conducted (brief ACT-based intervention vs. waiting-list control group)

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: February 1, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share