|- candidate number||19597|
|- NTR Number||NTR4836|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-okt-2014|
|- Secondary IDs||NL-49211.091.14 |
|- Public Title||Op Volle Kracht
|- Scientific Title||Op Volle Kracht: An intervention to increase emotional resilience among youth in residential treatment centres|
|- hypothesis||The aim of this study is threefold: (1) to test the effectiveness of OVK in reducing symptoms of depression compared to treatment as usual (TAU), (2) to identify mechanisms that can explain program effects, and (3) to test the effects of OVK on secondary outcomes. It is hypothesized that OVK will be more effective in reducing symptoms of depression in youth than TAU, immediately after the program and at three months follow-up. Regarding the explanatory mechanisms, it is hypothesized that OVK will decrease negative cognitive biases and increase adequate coping styles. Both of these constructs are expected to mediate the hypothesized effect of OVK on symptoms of anxiety and depression. |
Secondary outcomes include anxiety, behavioural problems, and group therapeutic climate.
|- Healt Condition(s) or Problem(s) studied||Depression, Anxiety, Emotional processing|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria:|
• Admitted to residential treatment within youth mental health care, the youth welfare system or care for youth with MID
• Age between 10;0 -16;11 years
• IQ > 60
|- Exclusion criteria||Participation in another clinical intervention study simultaneously
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||27-okt-2014|
|- planned closingdate||30-mei-2015|
|- Target number of participants||182|
|- Interventions||Op Volle Kracht is an CBT-based group intervention to increase emotional resilience among youth with and without mild intellectual disability (MID) in residential treatment settings. |
Adolescents will receive eight 45-minute group-sessions of the OVK-program within a period of 10 weeks. Within the sessions, adolescents are trained in the following cognitive-behavioural skills:
- to recognize and describe their feelings and thoughts
- to detect inaccurate thoughts
- to evaluate the accuracy of inaccurate thoughts
- to challenge inaccurate thoughts by considering alternative interpretations.
The sessions include group talks, individual- and group exercises, and video fragments. After each session, adolescents are assigned a homework task that takes approximately 15 minutes.
Two versions of the program ara available: (1) a program designed for adolesents with average or above-average cognitive capacities (TIQ >90) and age-appropriate social-emotional capacities; and (2) a version for adolescents with mild intellectual disability (TIQ 65-90) and delayed social-emotional development. The content of both versions of the program is the same, however regarding the structure both programs differ on the following points: (1) the MID version contains less verbal and more visual- and practical exercises than the non-MID version; (2) in the MID version adolescents receive more support from social workers (e.g. help in homework, help in detecting inaccurate thoughts and challenging their thoughts) than in the non-MID version; (3) the MID version places a stronger emphasis on behavioural techniques to influence the chain of thought-feeling-behaviour rather than cognitive techniques.
|- Primary outcome||The primary outcome will be depressive symptoms as measured by the Dutch version of the Children’s Depression Inventory (CDI) at T2 and T3. |
|- Secondary outcome||Secondary outcomes include anxiety, behavioural problems and responsiveness of group care workers.
Anxiety will be measured using the Dutch translation of the Spence Children’s Anxiety Scale (SCAS; Spence, 1997) for both parents and adolescents.
Behavioural problems will be assessed using the Strengths and Difficulties Questionnaire (SDQ; Goodman 1997) for both parents and adolescents.
Responsiveness of group care workers will be assessed using the subscale ‘responsiveness’ of the Dutch translation of the Prison Group Climate Inventory (Van der Helm, Stams, & Van der Laan, 2011).
Possible mediators include negative cognitive styles and coping styles. Negative cognitive styles will be measured with the Children’s Negative Cognitive Errors Questionnaire – Revised (CNCEQ-R; Maric, Heyne, van Widenfelt & Westenberg, 2011).
Response style and coping will be measured with the Children’s Response Style Questionnaire (CRSQ).
|- Timepoints||T1: Baseline assessment, approximately 1 month before the start of the program. All adolescents will fill out the CDI before they are informed about the condition they are assigne to.|
T2: 1 week prior to the start of the intervention. Adolescents will fill out the CDI, SCAS, CNCEQ-R, CRSQ, SDQ and PCGI subscale 'Responsiveness'. Parents will fill out the SCAS, CDI-2 parent version, and SDQ.
T3: 1 week after the last session of the intervention. Adolescents and parents will fill out the full battery as described at T2.
T4: Follow-up, three months after the last session of the intervention. Adolescents and parents will fill out the full battery as described at T2.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MSc. M. Weeland|
|- CONTACT for SCIENTIFIC QUERIES||MSc. M. Weeland|
|- Sponsor/Initiator ||Pluryn Research & Development, Radboud University Nijmegen|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Achmea|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||2-okt-2014 - 2-nov-2014|