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Working mechanisms in cognitive behaviour therapy for child anxiety disorders


- candidate number23987
- NTR NumberNTR5753
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-feb-2016
- Secondary IDsZonMw 729101010 
- Public TitleWorking mechanisms in cognitive behaviour therapy for child anxiety disorders
- Scientific TitleWorking mechanisms in cognitive behaviour therapy for child anxiety disorders
- ACRONYM
- hypothesisThe following working mechanisms are explored in this study: 1. Child factors (gender, age, comorbidity)
2. Parental factors (psychopathology, support, involvement)
3. Therapist factors (education, experience, alliance)
4. Therapy ingredients (feedback, CBT modules)

In addition, it will be examined which child needs basic or specialized mental health care (based on the Dutch system)
- Healt Condition(s) or Problem(s) studiedAnxiety disorders in youth, Cognitive behavior therapy
- Inclusion criteriaChildren, aged 8-18, with anxiety problems and who are in need for treatment (all anxiety disorders are included)
- Exclusion criteriaChildren and parents who are not proficient in the Dutch language
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2014
- planned closingdate1-jun-2017
- Target number of participants130
- InterventionsCognitive behavioural therapy (CBT): modular version of individual CBT: Discussing + Doing = Daring (Bögels, 2008). Therapy consists of 8 modules and the therapist is free to choose which modules he or she will apply. An exception is made for the first session, this has to be psychoeducation, and the last session of therapy has to be a summary and prevention of relapse. Main ingredients of the modules are: psycho-education, cognitive restructuring, mindfulness, exposure, coping, behavior experiments, prevention of relapse, and parent guidance.

Feedback informed treatment
All children receive CBT as described above. When therapy starts, children are divided into two groups: feedback or non-feedback. In the feedback group, therapists receive feedback from the measures that parents and children fill out after every session: treatment satisfaction, daily functioning, and anxiety symptoms. Therapists are asked to discuss this feedback with the child in the next session. Children in the non-feedback group also fill out these measures, but their answers are not send to the therapist.
- Primary outcomeTo examine effectiveness, primary outcomes are:
1. Decrease in anxiety disorders (SCID junior)
2. Decrease in anxiety symptoms (SCARED-71)

To investigate whether feedback improves child therapist alliance, the primary outcome is:
3. Therapist child alliance (WAI, WAI-O)
- Secondary outcome1. Parents internalizing symptoms (ASR)
2. Child behavioural problems (Brief Problem Monitor)
- TimepointsFor all participants, four assessments are conducted: Pre intervention, Halfway intervention, Post intervention, Follow up (after 10 weeks).

Next to these four assessments, all participants fill out a short questionnaire after each session.
- Trial web sitewww.denkendoendurven.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Liesbeth Telman
- CONTACT for SCIENTIFIC QUERIES Bonny Steensel, van
- Sponsor/Initiator University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsTelman, L., Van Steensel, B., Maric, M., & Bögels, S. (2015). Denken, doen, durven. Kind & Adolescent Praktijk, 14(3), 39-41.
- Brief summaryRationale: Anxiety disorders are common youth psychiatric disorders, and cognitive behavioural therapy (CBT) is the most efficacious treatment for anxiety disorders in children. Nevertheless, about one third of the children is not anxiety free after treatment. This study aims to examine the working mechanisms in child anxiety treatment. In particular, the influence of the therapist-child alliance on the efficacy of child CBT will be examined. This study is an innovative study into the effects of therapist feedback in child CBT.

Method: 130 Children and adolescents referred to mental health clinics are treated with a new version of the CBT manual “Discussing + Doing = Daring”, incorporating cognitive therapy, behavioral therapy, and mindfulness. Children are randomly assigned to either the ‘therapist feedback group’ or the control group (without therapist feedback). At pre-, mid-, post-, and 10 weeks follow-up treatment, children and parents complete a questionnaire measuring the child’s anxiety symptoms and child- therapist alliance. On a session-to- session basis, children and parents assess their treatment satisfaction, child daily functioning, and child anxiety symptoms. Feedback on these last three topics was provided to the therapists in the feedback group.

Implications: Data will be analyzed using innovative statistical techniques (i.e. multilevel modeling, mediation models). Results will contribute to a better understanding of the working mechanisms in child anxiety treatment. For example, if some factors have a positive or negative influence on treatment efficacy, the treatment could be adapted to specific target groups or to specific elements. Clinical implications will be discussed regarding the influence of the therapist-child alliance on CBT and whether assessing and using therapist feedback on a session-to- session base is useful.
- Main changes (audit trail)
- RECORD18-feb-2016 - 28-jun-2016


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