One of the recommendations of NICE for future research is comparing the effects of various psychological treatments for depression in youths. In particular, there is a need for studies in which parents are involved in the treatment (Birmaher et al…
ID
Source
Brief title
Condition
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All participants will complete a basline meeting, a measurement after treatment
has completed, and two follow-up measurements (three months and six months
after treatment completion). The following questionnaires will be completed:
The Anxiety Disorder Interview Schedule (ADIS; Siebelink & Treffers, 2001) is a
semi-structured interview assessing anxiety and depression, which is
administered by the research assistant during the baseline measurement (only if
it has not already been administered during the intake procedure). During the
measurement after treatment has completed, only the diagnoses that at baseline
will be re-assessed. The ADIS is not administered during the follow-up
measurements. The following outcome measures are to be completed during all
measurements:
Th Children's Depression Inventory (CDI; KOvacs, 1981) is used to measure
depressive symptomatology and consists of 27 items which contains three
statements (e.g., Sometimes I am sad; I am very often sad; I am always sad) of
which one has to be picked. The trait version of the State Trait Anxiety
Inventory for Children (STAI-C; Spielberger, 1973) is used to investigate
whether additional symptoms of anxiety will also be reduced as a result of the
depression treatment. The STAI-C consists of 20 items (e.g., I am afraid that I
might do things wrong) that are rated on a three-point scale (almost never,
sometimes, often).
In addition to these primary outcome variables, a number of process variables
are included. The Self-Perception Profile for Children
(Competentiebelevingsschaal in Dutch, Muris et al., 2003) is used to assess
(changes in) self-esteem in different domains of life. This questionnaire
contains 36 items. Respondents have to choose between two statements (e.g.,
Some children are very good at their schoolwork vs. Other children sometimes
worry about whether they do their schoolwork well). For each item, respondents
indicate whether the statement is entirely true or a little true. To measure
changes in social skills, the Social Skills Rating System (SSRS; van der Oord
et al., 2005) is used. The SSRS consists of 34 items (I easily make friends)
that are rated on a three-point scale (never, sometimes, often). To assess
changes in negative thoughts about the self, the world, and the future, the
Cognitive Triad Qestionnaire will be used (CTRK; Timbremont & Breat, 2006). Teh
CTRK consists of 36 items (I have lots of talents and skills) that are rated on
a seven-point scale (fully agree to fully disagree).
Both parents and the child complete a measure of rearing styles for which the
Egna Minnen Betraffende Uppfostran (EMBU; Castro et al., 1993) will be used.
The EMBU consists of 40 items that tap rearing styles that are directly related
to the concept of emotion coaching. With respect to the expected load, the ADIS
interview will take about 45 mintues and the remaining questionnaires will take
another 45 mintues. For parents, completion of the EMBU will take about 10
minutes.
Secondary outcome
not applicable.
Background summary
Depression is one of the most common psychological disorders in children and
adolescents. Prevalence rates vary between 2% and 8% (AACAP, 1998; Birmaher
e.a., 1998; De Wit & Kroesbergen, 1992). Cumulative prevalence rates are about
35% for females and 19% for males at the age of eightteen (Lewinsohn & Clarke,
1999). These numbers plea for the development of effective treatments of
depression in youths. In 2005, the National Institute for Clinical Excellence
(NICE) has produced guidelines with respect to psychological treatments of
depression in children and adolescents (see for a summary Murray &
Cartwright-Hatton, 2006). According to these guidelines, cognitive-behavioral
therapy (CBT), interpersonal psychotherapy, and short-term family therapy are
among the evidence-based treatents, which have proven its effectiviness in
randomized controlled trials for moderate to severe depression in children and
adolescents.
CBT in children and adolescents can be divided into an operant part and a
cognitive part. The operant part of the treatment is inspired by the work of
Lewinsohn et al. (1984) as well as of Martell et al. (2001), and consists of
gradual increase of pleasurable and satisfying events, excercising social
skills, and teaching problem-solving techniques. The content of the cognitive
part is less strictly defined in the literature. In many protocols, negative
automatic thoughts are traced and challenged by the therapist according to the
methods described by Beck et al. (1979). Additionally, elements form rational
emotive therapy (Ellis, 1962) and increasing coping skills are subsumed under
the heading 'cognitive'.
Research aimed at examining the effectiviness of CBT for depression in children
and adolescents has started in the eighties by means of case studies (see for
example Frame et al., 1982; Petti et al., 1980). These case studies were the
first step towards randomised controled studies examining the effectiveness of
CBT in children and adolescents (see for example Reynolds & Coats, 1986; Stark
et al., 1987; Lewinsohn et al., 1990; Lerner & Clum, 1990; Kahn et al., 1990;
Vostanis et al., 1996; Wood et al., 1996). A meta-analsis in which the
aforementioned studies are included showed a medium effect size (d=0.68) in
reducing symptoms of depression in chilren and adolescents and that long-term
effects are favorable (Reneicke et al., 1998). The effectiviness of CBT can be
increased by involving the parents in the treatment.
Study objective
One of the recommendations of NICE for future research is comparing the effects
of various psychological treatments for depression in youths. In particular,
there is a need for studies in which parents are involved in the treatment
(Birmaher et al., 1996; Kaslow & Racusin, 1994). This research proposal is a
pilot study (in preparation to a multi-centre trial), in which individual
cognitive therapy for the child is compared to individual cognitive therapy for
the child added by emotion coaching of the parents (Gottman, 1997). The most
important primary goals of this study are to finetune both treatment protocols
on the basis of experiences from therapists and to compute an effect size of
both treatments in order to be able to conduct a power calculation for the
multi-center trial. In addition, the secundary goal of this study is to
evaluate the reduction in depressive symptoms as well as to evaluate the role
of some important process variables. These evaluations will be done in a
descriptive way (will not be statistically tested) due to the limited numbers
of participants.
Study design
This study is an intervention study in which youths aged between 10 and 17
diagnosed with depressive disorder are randomly allocated to indidivual CBT or
individual CBT with emotion coaching of the parents. Random allocation to each
of the two treatment arms is done after participants have received information
and signed the consent form. As this study examines the added effect of emotion
coaching, and the effectiveness might depend on the age of the child, we choose
to stratify on age. Youths are divided in two groups: 10 to 12 and 13 to 17
years old. Within these strata, randomisation to either of the two treatment
arms occurs. In all participants, a baseline measurement, measurement after
treatment is completed as well as two follow-up measurements will take place.
Intervention
The construction of individual CBT is derived from the treatment protocol used
in adults (Boelens, 2004). The CBT is adapted to the perception of the
environment of children and adolescents. The CBT consists of 12 sessions with
the child in which the first six sessions are devoted to operant techniques
(increase pleasurable activities, exercising social skills), whereas the
remaining six sessions are devoted to cognitive techniques according to the
method of Beck (Beck et al., 1979), in which negative automatic thoughts are
being traced and challenged in a way that suits children and adolescents. In
the protocol, there is also room for tracing and challenging anxious
cognitions. The end of the treatment is focused on the prevention of relapse.
Parents are seen three times during the treament: sessions one, six and twelve
(last session).
For emotion coaching, parents are seen four times apart form their child (in
addition to the three times in the CBT protocol). These four sessions are
devoted to emotion coaching. In the first session, a meta-emotion interview
takes place with the purpose of letting parents become aware of their own
emotions. In the remaining sessions, parents learn how to respond to the
emotions of their child (anxiety, depressed mood, and anger). Whit the approval
of the child and the parents, all sessions are taped so that treatment
adherence can be examined. Every session has homework. Both CBT and emotion
coaching have been carefully checked by a group of well experienced therapist.
Study burden and risks
The burden is minimal and risks are neglectable.
Universiteitssingel 50
6200 MD Maastricht
Nederland
Universiteitssingel 50
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
* Primary diagnosis of major depressive disorder or dysthymic disorder
* Age between 10 - 17
* IQ > 80
* Being able to speak, read and understand the Dutch language
For parents, inclusion will take place when permission is given for their child and the parents themselves to participate in this study and in the case that they will be able to sufficiently speak, read and understand the Dutch language.
Exclusion criteria
* Depression with psychotic features or psychotic decompensation
* Mentally retarded
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 |
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CCMO | NL17507.068.07 |