The main objective of this study is to evaluate what a newly developed, theory-driven, personalized app, adds to the short- and long-term effectiveness of the existing OST intervention in terms of anxiety symptom reduction and relapse.Three…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be the clinician severity rating of the specific
phobia, an assessment of behavioral avoidance of the feared stimulus with the
Behavioral Avoidance Task, the Sheehan Disiability questionnaire to assess
interference with daily life and a form on which the specific fear(s) are
listed with a rating of how afraid the child is of this object/situation and
how often he/she avoids this.
Secondary outcome
In addition to the primary measures several secondary measures will be
administered in order to describe the population and investigate possible
underlying mechanisms and predictors of treatment:
Child
- Interpretation bias will be assessed wit an Ambiguous Scenarios Task (AST)
- Sensation seeking will be assessed with the Sensation Seeking Scale for
Children
- Habituation is assessed with a 0-8 subjective units of distress scale (SUDS)
about how scared the child is, is administered multiple times
- Expectation violation/harm beliefs are assessed by asking the child several
questions throughout treatment regarding his/her beliefs about what might
happen and what did actually happen
- Emotional problems will be assessed with the Short Mood and Feelings
Questionnaire (SMFQ)
- ambivalent and avoidant reactions to attachment situations assessed with the
Experiences in close relationships-Child Questionnaire
- Imagery or flash forwards will be assessed with a short interview and a short
questionnaire
Child and Parent
- Parent and child self-efficacy will be assessed with the General Self
Efficacy Questionnaire (GSE) and an adapted version for children
- Comorbidity will be assessed with a structured clinical diagnostic interview
at intake
- Comorbid anxiety will be assessed with the Spence Children's Anxiety Scale
(SCAS)
- Motivation for treatment will be assessed using the Motivation Questionnaire
- Credibility and expectancy of the treatment will be assessed with the
Credibility and Expectancy Questionnaire (CEQ-C/P)
- Treatment compliance/time practiced; parents and children are asked how often
they have practiced
- Treatment satisfaction will be assessed with three self and parent report
items
- usability of and satisfaction with the app assessed with a short
questionnaire (only in app condition)
- Parental coping with negative emotion assessed with an adapted version of
the Child Development Questionnaire (CDQ)
-Positive mental health assessed with the Positive Mental Health Scale (PMH)
Parent
- Comorbid autism spectrum symptoms will be assessed with the Autism Spectrum
Quotient (AQ)
- parental mentalization about their own functioning and the functioning of
their child assessed with the Reflective (Parental) Functioning Questionnaire
- Parental mental health problems will be assessed using the Depression Anxiety
Stress Scales (DASS) and a form on which specific fear(s) an be listed with a
rating of how afraid the parent is of this object/situation and how often
he/she avoids this.
- Demographic information will be gathered through a questionnaire
- Fear of Negative Child evaluation will be assessed with the Fear of Negative
Child Evaluation Questionnaire (FNCE-Q)
Researcher
- Parental coping with the child's negative and positive emotions will be
assessed by rating video clips of the homework session in which children and
parents discuss how they will keep practicing exposure at home and what rewards
the child can earn.
- Treatment integrity will be assessed by scoring recorded therapy sessions
Researcher, parent and child
The (Clinical) Global impression and improvement scale will be used to assess
perceived improvement by therapist, parent and child
Background summary
Specific phobia is de most common mental disorder in children and can interfere
greatly with daily life. Many children with a specific phobia do not receive
the treatment they need. In addition, not all children that do get treatment
profit enough from the treatment. The aim of the current study is to study how
we can offer a treatment that is effective, easily accessible for everyone and
does not stigmatize.
Study objective
The main objective of this study is to evaluate what a newly developed,
theory-driven, personalized app, adds to the short- and long-term effectiveness
of the existing OST intervention in terms of anxiety symptom reduction and
relapse.
Three secondary objectives of this study are:
1) Replication of the effectiveness of standard OST for childhood specific
phobias in a Dutch and German sample.
2) Investigating underlying mechanisms of OST, including self-efficacy,
interpretation bias, and habituation and expectation violation.
3) Exploring possible predictors of treatment outcome, by examining child and
family factors.
Study design
This study employs a multicenter pragmatic randomized controlled trial with 2
active treatments, and a 3-week waiting baseline control period. Accessors will
be blind to treatment condition.
Intervention
The OST will be a 3-hour session in which the child is gradually exposed to the
feared object or situation. After the OST, one group will receive an app that
helps the child to complete exposure exercises for 4 weeks following treatment,
the other group is instructed by the therapist to keep practicing at home but
will not receive the app to assist them with this (Treatment as Usual).
Study burden and risks
A direct benefit for the children participating in this study, is that they
will receive an effective intervention (the OST) to treat their specific
phobia. Additionally, a potential indirect benefit of participating is that in
case the specific phobia has not reduced enough after the intervention or if
children experience different mental problems, they will be offered additional
care either by a booster session, re-intake in the current or redirection to
another mental health care center. In this way the current study may lower the
threshold to seek help for any additional problems as well.
A burden for the participating children and their parents is that they have to
visit the clinic six times during the study. However, five out of six visits
are part of care as usual. The burden of participation in this study is
comparable to other treatment studies in childhood psychiatry. The burden of
the treatment received in this study is less then with treatment as usual,
since the intervention that will be used consists of only one massed exposure
session, a preparation session and homework instructions instead of the usual
12 session interventions. This leads to improvements in a shorter period of
time and in this way likely prevents more distress in daily life sooner than
without this treatment.
The only risk of participation is brief distress during the exposure exercises.
The level of distress during these exercises will not exceed the distress
children experience when they encounter the phobic stimuli in daily life or the
distress experienced in regular treatment (in which exposure exercises are also
an important component). To the best of our knowledge, using an online platform
to deliver the maintenance program of an intervention doesn*t bring any risks.
In addition, a recent pilot study in the United States showed that an exposure
focused app was an acceptable addition to standard anxiety treatment for
children, parents and therapists. No adverse effects were reported.
Because of the reasons stated above we are of the opinion that the benefits of
participating outweigh the burden and risks of participation. Additionally, we
think the current research question is most relevant in children, as opposed to
adults, since specific phobias usually develop in early childhood. Therefore,
we are restricted to the use of the proposed age group.
Wassenaarseweg 52 151
Leiden 2333AK
NL
Wassenaarseweg 52 151
Leiden 2333AK
NL
Listed location countries
Age
Inclusion criteria
(a) Meet DSM-IV criteria for a specific phobia with a severity score of 4 or
higher determined with the anxiety disorders interview schedule ( ADIS-IV-C/P)
(b) At least one parent/caregiver is willing to be involved in the study and
active consent is obtained from both legal guardians and of the child if 12
years or older
(c) Fluent in German (Bochum site), Dutch (sites in the Netherlands) or
English (all sites)
(d) 7 - 14 years of age
Exclusion criteria
(a) A comorbid problem that requires attention/treatment more immediate than
the specific phobia (e.g. severe depressive symptoms, suicidal ideation,
psychosis, trauma)
(b) Child hazard (e.g. suspected child maltreatment)
(c) Problems with understanding the procedure (e.g. being intellectually unable
or nonverbal)
(d) Changes in anxiety medication during the treatment
(e) Other treatment targeting anxiety complaints at the time of the study
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | NL 9216 |
| CCMO | NL72697.018.20 |
| OMON | NL-OMON22841 |