REMAIN: Feasibility and Acceptability of Problem Management Plus (PM+) for Refugee Adolescents Living in the Netherlands

REMAIN: Feasibility and Acceptability of Problem Management Plus (PM+) for Refugee Adolescents Living in the Netherlands - Implementation of PM+ in refugee adolescents

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56254

Enrollment

105

Registered

2020-07-01

Start date

2022-01-18

Completion date

Unknown

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological symptoms of anxiety, (posttraumatic) stress and depression anxiety depression distress Psychological symptoms

Interventions

There will be two treatment groups and one care as usual (CAU) comparison group in the pilot RCT phase. Participants in the first group (n= 30) will receive six sessions of Problem Management Plus (

Eligibility

Age

16 Years to 64 Years

Inclusion criteria

Inclusion criteria: - 16 to 25 years old - Arabic, Tigrinya or Ukrainian speaking - Elevated levels of psychological distress (K10>15) and reduced psychosocial functioning (WHODAS 2.0 (minor adaptations for adolescents)>16)

Exclusion criteria

Exclusion criteria: - Acute medical conditions - Imminent suicide risk or expressed acute needs and protection risks. - Severe mental disorder (psychotic disorders, substance-dependence) - Severe cognitive impairment (e.g. severe intellectual disability) - Currently receiving a psychological treatment within specialized mental health care [Specialistische jeugdhulp or specialistische GGZ] - In case of current psychotropic medication use: change in dosage during the past 2 months. - Diagnosis of PTSD directly related to severe and repeated neglect, physical abuse, and/or sexual abuse in childhood, identified by CAPS-V interview during the baseline assessment.

Design outcomes

Primary

Measure	Time frame
The primary study parameter for the pilot study will be the feasibility and acceptability of PM+ interventions. The feasibility criteria are composed of recruitment and consent rates, attendance, fidelity to the protocols, adverse events and the perceptions about the PM+ interventions.	—

Secondary

Measure	Time frame
Secondary parameters will be the reduction in self-reported psychological distress scores, measured with the Hopkins Symptom Checklist (HSCL-25). Assessments of participants will take place before PM+, 1-week post-PM+ and 3 months follow-up for all groups.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)