Primary Objective: Is the intervention model feasible and acceptable for clients, parents/caregivers, peers and therapists?Secondary Objective(s): 1) Establishing first evidence of efficacy of peer-mentored CBT in reducing anxiety in adolescents…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Semi-structured interviews with clients, parents/caregivers, peer-mentors and
therapists about feasibility and tolerability of the intervention. Interviews
will be coded using deductive and inductive coding. Deductive codes will be
based on the acceptability framework. Inductive codes will be organized in
overarching themes.
In addition information regarding inclusion rate, compliance with measurements
and adherence to therapy sessions will be used to assess other aspect of
feasibility.
Secondary outcome
1) Anxiety symptoms, anxiety diagnosis and percentage of steps taken in
behavioral approach test
2) Anxiety symptoms and self-efficacy of peer-mentors
3)A semi-structured interview with therapists about usefulness of receiving an
individualized strength/weakness profile.
Background summary
Anxiety disorders are one of the most prevalent clinical disorders in
adolescents, and even more in adolescents with mild to borderline intellectual
disability (MBID, i.e., IQ<85 and limitations in adaptive functioning).
Exposure based CBT is currently viewed as the most effective form of treatment
, however, with response rates of 30% for adolescents with MBID there is still
much to be gained by boosting efficacy. Given the risks of long-term negative
outcomes associated with anxiety disorders, the need for an (even more)
effective intervention is clear. Adolescence is known as a period in which
peers are an important social influence that greatly impacts the behaviour of
adolescents, even more so for adolescents with MBID. Based on this making use
of social learning during treatment might be a powerful port-of-entry for
adolescents with MBID and anxiety disorders.
Study objective
Primary Objective:
Is the intervention model feasible and acceptable for clients,
parents/caregivers, peers and therapists?
Secondary Objective(s):
1) Establishing first evidence of efficacy of peer-mentored CBT in reducing
anxiety in adolescents with MBID.
2) Do the peer-mentors themselves also experience further anxiety reduction and
increase in self-confidence ?
3) Is it beneficial for treatment effect to include pre-treatment assessment
with a strengths and weaknesses profile for clients with MBID?
Study design
Embedded mixed methods design where the quantitative part consists of a single
case experimental design with daily measurements during a baseline and
treatment phase. Participants are randomized over two baseline lengths (2 and 4
weeks) and clients and peer-mentors keep a daily diary. In addition,
questionnaires and behavioral measures are used to assess anxiety and
self-efficacy at pre-baseline, pre-treatment, mid-treatment, post-treatment and
follow-up. Finally, clients report on client satisfaction after each session.
Measures are taken from clients, parents, therapists and peer-mentors.
Intervention
In this study we will use the intensive exposure therapy model, which includes
longer exposure sessions of three hours during which clients practise with
their feared subject. The intervention starts with an anxiety analysis session,
followed by three exposure sessions, a home-work session, 4 weeks of
independent practice and an evaluation session. The new element to the
intervention in this study is that a peer-mentor with lived experience will be
present during exposure session 1 and 2. Their role is that of model,
information source and supporter. The therapist is present during all sessions.
For participants with MBID, guidelines recommend tailoring treatment to
individual cognitive strengths and weaknesses. To gather information on the
usefulness of establishing individual strength/weakness profiles prior to
treatment, we will request information on strengths/weakness profiles from the
organisation who assessed the client. For participants who have a
strength/weakness profile we will make individualised recommendations for the
therapist. For participants who do not have a strength/weakness profile, the
therapist will receive general recommendations for providing therapy for
adolescents with MBID.
Study burden and risks
All clients sought out mental healthcare for help with anxiety problems and the
core of the intervention is exposure therapy, which is the first choice
treatment for anxiety disorders. All clients receive treatment, there is no
waitlist of placebo group. The burden to participants mainly lies in time
investment in the study measurements and keeping a daily diary. We believe to
be the burden to be reasonable and have limited the number the time spend on
measurements as much as possible.
Sint Jorisweg 2
Delft 2612GA
NL
Sint Jorisweg 2
Delft 2612GA
NL
Listed location countries
Age
Inclusion criteria
Clients: 12-21 years old • An anxiety disorder diagnosis, which will be
confirmed using the SCID-5-Junior interview • A support system should be in
place to help the adolescent during the treatment. • IQ 55-85 • Significant
limitations in adaptive functioning, ABAS-3 score <85
Peer-mentors:
• 12-21 years old
• Has received a MBID diagnosis in the past
• Has finished treatment for at least one anxiety disorder
Exclusion criteria
• IQ < 55 • Other anxiety focused psychological treatment concurrent with the
study. Concurrent psychopharmacological treatment is not an exclusion
criterion, but participants should be on the correct dosage at the start of the
study baseline period. Dosage changes during participation are an exclusion
criterion. • Severe language or communication problems that would interfere
with treatment
Peer-mentors:
- severe communication or language problems that would interfere with the role
pf peer-mentor
- peer-mentors will not be matched to an intended client if they know each
other
- peer-mentors will not be matched to an intended client if they experience a
clinical level of anxiety on the same topic as the client.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL84418.058.23 |