Clinical trial NCT05218031: Acceptance and Commitment Group Therapy for Unaccompanied Minors
Official title: Acceptance and Commitment Group Therapy for Unaccompanied Minors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Depression
Anxiety Disorders
Keywords: Unaccompanied Refugee Minors
Acceptance and Commitment Therapy
Child/Adolescent Mental Health
Quality of Life
Lead sponsor: University of Cyprus
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 70
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm randomised trial will be conducted (brief ACT-based intervention vs. waiting-list control group)
Primary purpose: TREATMENT

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:

1. 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).
2. The UM receiving the ACT group intervention will demonstrate improvements in their prosocial behaviour compared to the WL control group. (Primary outcomes).
3. 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).
4. 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.

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.

Primary outcomes:
measure: Change in 'Quality of Life': KIDSCREEN-27 (Ravens-Sieberer et al., 2007).
timeFrame: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
measure: Change in 'The Depression, Anxiety and Stress Scale' (DASS-21; Lovibond & Lovibond, 1995; Antony, Bieling, Cox, Enns, & Swinson., 1998).
timeFrame: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
measure: Change in 'The Child Revised Impact of Events Scale' (CRIES-8; Perrin, Meiser-Stedman, & Smith., 2005).
timeFrame: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
measure: Change in 'Strengths and Difficulties Questionnaire' (SDQ; Goodman, 1997; 2001).
timeFrame: Pre-intervention, Post-intervention (at 5 weeks), 1-month follow-up, 3-months follow-up
Secondary outcomes:
measure: Change in the ACT Process Measure: PsyFlex (Gloster et al., 2021).
timeFrame: Pre-intervention, throughout study completion 5 weeks, 1-month follow-up, 3-months follow-up
Other outcomes:
measure: Treatment Adherence Measure: ACT Fidelity Measure (ACT-FM; O'Neill et al., 2019).
timeFrame: up to 5 weeks
Locations:
Study officials:
affiliation: University of Cyprus
name: Maria Karekla, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: