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van CCT (UK)

van CCT (UK)

Effectiveness of the (POPP) treatment program in sexually abused preschool girls: a randomized controlled trial

- candidate number23158
- NTR NumberNTR5416
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-okt-2015
- Secondary IDsNL50473.091.14 CMO Regio Arnhem Nijmegen
- Public TitleEffectiveness of the (POPP) treatment program in sexually abused preschool girls: a randomized controlled trial
- Scientific TitleEffectiveness of the Power of Projection in Play (POPP) treatment program in sexually abused preschool girls: a randomized controlled trial
- ACRONYMPOPP treatment for sexually abused preschool girls
- hypothesisPOPP treatment will lead to more PTSD symptom reduction compared to wait list.
- Healt Condition(s) or Problem(s) studiedPosttraumatic stress symptoms
- Inclusion criteriaThe criteria for inclusion are a) increased levels of PTSD symptoms, b) PTSD symptoms related to sexual abuse, and c) the child has reached the developmental level of symbolic play.
- Exclusion criteriaExclusion criteria are a) the absence of parental permission, b) severe psychiatric conditions that require an emergency response (suicidal intent, psychotic symptoms, or severe dissociations), c) the most recent episode of sexual abuse occurred more than 12 months before referral to the study, and d) lack of a long-term caretaker or severe family problems (lack of stability for the ongoing six months).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2015
- planned closingdate1-apr-2018
- Target number of participants40
- InterventionsThe POPP treatment program is based on Trauma Focused-Cognitive Behavior Therapy (TF-CBT) techniques, with a newly described central position for projection and healing play. Ten treatment sessions (for a maximum of 60 minutes each) are offered, along with parental guidance. Under the waiting list condition, the POPP treatment program starts after three months.
- Primary outcomePTSD symptoms from baseline to post-intervention. The change in PTSD symptoms between the experimental and control group is compared at post-intervention.
- Secondary outcomeSecondary outcomes are: Anxiety, Depression, Anger/Aggression, Dissociation, Sexual Concerns and General behavioral problems
- TimepointsThe assessments will be conducted at baseline (T1), three months later at post-intervention (post-immediate POPP treatment, or at the end of waiting list: T2), and six months later (follow-up of immediate POPP treatment or post-treatment in the waiting list condition: T3)
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIES Lisette Kerssemakers
- Sponsor/Initiator GGZ Oost Brabant
- Funding
(Source(s) of Monetary or Material Support)
GGZ Oost Brabant
- Publicationsn/a
- Brief summaryThe main objectives of the present study are: assessing the effectiveness of the POPP-treatment program in girls aged 3-6 years with posttraumatic stress reactions following sexual abuse
- Main changes (audit trail)
- RECORD22-okt-2015 - 29-okt-2015

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