The primary goal of this study is to evaluate whether therapist supported in-session exposure exercises are more effective than individual out-session exposure exercises, or parent supported out-session exposure exercises. The secondary goal is to…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is specific phobia diagnosis of the animal/situational
subtype.
Secondary outcome
Secondary:
Subjective level of fear
Fearful cognitions
Bodily tension
Avoidance
Coping
Approach behaviour
Self-efficacy
Other:
Healthcare costs
Quality of life
Specific phobia severity
General comorbidity
Comorbid anxiety and depression
Parental fear
Parental modelling behaviours
Demographic variables
Credibility and expectancy of the treatment
Treatment compliance
Treatment satisfaction
Treatment integrity
Therapeutic alliance
Background summary
Anxiety problems are a major concern of youth mental health given that the
prevalence of anxiety disorders in Dutch children aged up to 12 is
approximately 4 to 8 percent (Nederlands Jeugd Instituut, 2016). In this group,
specific phobias are among the most common. Cognitive Behavioral Therapy (CBT)
with exposure as its key ingredient, takes a prominent place in national
guidelines for the treatment of anxiety disorders. These guidelines are based
on empirical support that exposure is effective in the treatment of specific
phobia (Wolitzky-Taylor et. al. 2008; Craske, 1999). Yet, despite the empirical
evidence of its efficacy, a gap between theory and practice remains, with
exposure-based interventions CBT being underused in clinical practice. For
example, a recent Dutch survey found that exposure was mostly practiced outside
the formal therapy sessions as homework assignment (Sars & van Minnen, 2015).
It is questionable whether this is effective, given that it might be hard for
children to do these assignments independently (e.g., without the help of a
therapist or their parents). This study therefore proposes to evaluate the
effectiveness of different degrees of therapist and parent involvement during
exposure, from comparing therapist supported exposure to with self-supported
exposure with or and without the use of parents as co-therapists.
Study objective
The primary goal of this study is to evaluate whether therapist supported
in-session exposure exercises are more effective than individual out-session
exposure exercises, or parent supported out-session exposure exercises. The
secondary goal is to find child, parent and therapist factors that possibly
relate to the effectiveness of the exposure exercises.
Study design
Single-blind parallel randomized controlled trial (RCT) with three parallel
groups (intervention versus intervention versus intervention).
Intervention
Three conditions receiving each three sessions:
A. 1 Psycho-education session (PE) + 2 exposure sessions with the therapist
(EXP)
B. 1 PE + 2 EXP sessions in which the homework exercises for the child are
prepared and evaluated
C. 1 PE + 2 EXP sessions in which the homework exercises for the child together
with the parent are prepared and evaluated
Study burden and risks
The potential value of the current study is that we gain insight in the most
optimal degree of therapist and parent involvement during exposure in the
treatment of anxiety in youth. Regarding this insight we can provide therapists
with evidence-based recommendations for optimizing their treatment of children
with anxiety disorders. A possible direct benefit of participating in this
study, is that we offer children with a specific phobia an effective
intervention to treat their anxiety disorder. A possible indirect benefit of
participation is that in case the provided intervention was not sufficient in
reducing the specific phobia, participants will be invited for a re-intake and
provided with additional care at the current or another mental health care
center. A burden for the participating children and their parents is that they
have to visit the mental health care center seven times during participation in
this study. However, given that four out of the seven visits are part of care
as usual, we consider this burden justifiable. It*s the intake, treatment
sessions and a number of questionnaires in the assessments, like the RCADS,
SCAS and SEQ, that are part of care as usual. In addition, the used
intervention is less of a burden than care as usual, given that the current
intervention exists of three sessions, whereas the care as usual intervention
consists of twelve sessions. Therefore, we only consider the additional
interviews, questionnaires and behavioral test during the assessments as a
direct burden for participation. However, the duration of the assessments is
limited to 80 minutes, with a number of questionnaires shortened to Visuals
Analogue Scales (VAS). Therefore the burden for participating in this study is
comparable to other studies in the child- and adolescent psychiatry. In
addition, the only risk of participation is short-lived distress during the
exposure exercises. This level of distress will not exceed stress as
experienced when encountering the feared object or situation in daily life or
in regular treatment. Therefore, we are of opinion that this burden and risk
outweigh the potential benefits of less anxious children. Moreover, we consider
the research question most relevant to children, and less relevant to
adolescents or adults, who generally do not involve their parents in treatment.
This means that for answering this question we are restricted to group
relatedness.
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Listed location countries
Age
Inclusion criteria
* Aged between 8-12 years old and in primary school
* Sufficient knowledge of the Dutch language
* Meeting the criteria of a specific phobia of the situational or animal subtype
Exclusion criteria
* Absence of permission of legal guardian(s)
* Currently in treatment or receiving medication for anxiety
* Received Cognitive Behavioural Therapy for anxiety in the past 12 months
* Specific phobia that do not fall under the situational or animal subtype
* Different and more urgent request for help
* (Risk of) suicidality, psychosis or domestic violence
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 | NL59889.042.16 |
Other | wordt aangemeld bij NTR |