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van CCT (UK)

van CCT (UK)

Treatment of PTSD in children

- candidate number15807
- NTR NumberNTR4301
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2013
- Secondary IDs*80-82470-98-006-04 & **NL36971.091.11 *ZonMW & **CCMO
- Public TitleTreatment of PTSD in children
- Scientific TitleThe effectiveness of brief Intensive Exposure Therapy (IET) for children with Posttraumatic Stress Disorder (PTSD)
- hypothesisThe present study aims at the improvement of the treatment of children with PTSD by examining the effectiveness of a brief intensive exposure therapy (IET) for children with PTSD using a multiple baseline design (patients are randomly assigned to baseline length).
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD)
- Inclusion criteria(1) Current DSM-IV diagnosis of PTSD established with the PTSD section of the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL)
(2) Age between 7 and 18 years (boys & girls)
- Exclusion criteria(1) Psychosis or delusion disorders (current or in the past)
(2) Suicidality
(3) Mental retardation
(4) Substance abuse or dependence or alcohol abuse or dependence
(5) Insufficient ability to speak and write Dutch
(6) Trauma caused by a caregiver who is part of the current primary care system
(7) Current DSM-IV diagnosis of PTSD of the caregiver established with a structured diagnostic interview (M.I.N.I.) and the PTSD Symptom Scale Self-Report (PSS-SR)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-dec-2012
- planned closingdate20-dec-2014
- Target number of participants10
- InterventionsBrief intensive modified exposure therapy and a trauma-related social support program for family members:
5 days (one week), offered in three blocks of 90 minutes each day and up to three follow up appointments (90 minutes each)
- Primary outcomePTSD symptoms, self-report by child: UCLA PTSD Reaction Index (PTSD-RI)
- Secondary outcomeChild measures
- PTSD symptoms: PTSD section of the K-SADS-PL; UCLA PTSD Reaction Index (PTSD-RI)
- Depressive symptoms: BDI-II
- General functioning: SCARED; PedsQL; GCI; #schooldays
- Dissociative symptoms: dissociation section of the BPD-47
- Social support after the trauma happened
- Disclosure of the traumatic event
- Avoidance: PABQ

Parent measures, about psychopathology of the child
- PTSD symptoms: UCLA PTSD Reaction Index (PTSD-RI)
- General functioning: PedsQL; GCI

Parent measures, about own psychopathology
- General functioning: GCI; OQ-45.2; BDI-II
- PTSD symptoms: PSS-SR (about possible own traumatic events and about the traumatic event of the child)
- Avoidance: PABQ
- TimepointsTime points of primary interest (primary outcome)
Weekly during:
- Baseline length (varying from 4 to 8 weeks before treatment)
- Treatment length (5 weeks)
- Post treatment length (varying from 4 to 8 weeks after treatment)
- Follow up length (during 4 weeks, 3 months after treatment)

Time points secondary outcomes
- before treatment (A0)
- three weeks after baseline (A1)
- three months after baseline (A2)
- and six months after baseline (A3)
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT for SCIENTIFIC QUERIESProf. dr A. Minnen, van
- Sponsor/Initiator Behavioural Science Institute, Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe present study aims to examine the effectiveness of a brief intensive exposure therapy for children with PTSD. The new treatment program makes use of proven effective therapy techniques in processing the trauma and decreasing PTSD symptoms in children, whereas the delivery of the treatment is using a new format: one week of intensive trauma-focused treatment while including a trauma-related social support program for family members.

Country of Recruitment: The Netherlands
- Main changes (audit trail)
- RECORD2-dec-2013 - 5-jun-2017

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