Primary Objective: To evaluate the feasibility and acceptability of the culturally and contextually adapted WHO*s PM+ intervention for Arabic, Tigrinya and Ukrainian speaking refugee youth living in the Netherlands.Secondary Objective:1. To evaluate…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
Psychological symptoms of anxiety, (posttraumatic) stress and depression
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Common mental health problems are prevalent among refugee minors and impair
their daily functioning. Due to various barriers such as lack of culturally
appropriate treatments, waiting lists, and stigma they have limited access to
care. Problem Management Plus (PM+) was developed by the World Health
Organization to address these barriers. PM+ is transdiagnostic, is delivered by
non-professional helpers, and consists of 5 sessions of problem-solving skills,
behavioural activation and stress management. Currently, PM+ does not consist
of a trauma processing module specifically targeting symptoms of PTSD. PM+ is
effective in reducing adults* distress and improve functioning. We aimed to
adapt PM+ for refugee minors and add an emotional processing module to target
symptoms of posttraumatic stress disorder.
Study objective
Primary Objective:
To evaluate the feasibility and acceptability of the culturally and
contextually adapted WHO*s PM+ intervention for Arabic, Tigrinya and Ukrainian
speaking refugee youth living in the Netherlands.
Secondary Objective:
1. To evaluate the feasibility and acceptability of PM+ with a newly developed
Emotional Processing module (PM+ EP) among refugee minors in the Netherlands.
2. To assess the feasibility of the outcome measures in preparation of a future
larger RCT evaluating the effectiveness of the adapted versions of PM+.
Study design
Phase 1: A qualitative study for adaptation of PM+ manual to refugee
adolescents living in the Netherlands (discussed in a seperate protocol,
reference number: 2019.441).
Phase 2: An exploratory, single-blind pilot randomized controlled trial (RCT).
Phase 3: A qualitative study to evaluate the process following the pilot RCT.
Intervention
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 (PM+) as well as care as usual (CAU).
The second group (n= 30) will receive six-sessions of an adapted version of
PM+, which includes an emotional processing module (PM+ EP) as well as CAU. The
third group (n= 30) will receive CAU only.
Study burden and risks
Participants enrolled in the PM+ treatment group will receive six
seventy-five-minute PM+ sessions, which will be audiotaped for supervision and
monitoring. Participants enrolled in the PM+ EP group will also receive six
seventy-five-minute adapted PM+ sessions that include emotional processing.
Additionally, interested participants will be invited for a total of three
assessment interviews including screening and post-assessments. These
assessment interviews will be carried out by trained assessors and participants
will be asked to fill in questionnaires on daily functioning, psychological
complaints, adverse experiences, and daily problems. These interviews will take
approximately 2,5 hours.
van der Boechorststraat 7
Amsterdam 1081 BT
NL
van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72668.029.20 |