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Effectiveness of a cognitive-behavioural based group intervention for children with chronic disease
ISRCTN ISRCTN60919570
DOI 10.1186/ISRCTN60919570
ClinicalTrials.gov identifier
EudraCT number
Public title Effectiveness of a cognitive-behavioural based group intervention for children with chronic disease
Scientific title Effectiveness of a cognitive-behavioural based group intervention for children with chronic disease: a multicentre randomised controlled trial
Acronym Samen Op Koers
Serial number at source ZonMw: 80-82435-98-8038
Study hypothesis This project is aimed to study the extent to which the cognitive behavioural-based group intervention Op Koers is effective in increasing or stabilising psychosocial wellbeing in children with a chronic disease. This study will also examine the extent to which parental involvement enhances the effectiveness of Op Koers.

Primary hypothesis:
Children participating in Op Koers will show greater improvement on the outcome measures than children in the waiting list group at post-treatment, 6 and 12 months later. Differences between the groups are expected to be largest with respect to the skills central to the program, such as information seeking, relaxation and positive thinking (Op Koers questionnaire). Effects on cognitive coping skills might be moderate right after the program, based on the effects in a previous pilot study, but are expected to increase at 6 and 12 months after the program due to repeated use of these skills. As a result of increased resilience, the differences on social emotional functioning are also expected to increase.

Secondary hypothesis:
Children with parents who participated in Samen op Koers will show greater improvement on the outcome measures compared to both the Op Koers and waiting list condition post-treatment, 6 and 12 months later. Effects are hypothesised to be similar in direction but stronger than for the Op Koers intervention compared to the waiting-list group.
Lay summary Not provided at time of registration
Ethics approval Medisch Ethische Commissie (Medical Ethical Committee) Academisch Medisch Centrum (AMC) approved on the 21st March 2009 (ref: MEC08/369 #09.17.0515)
Study design Multicentre randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Chronic illness
Participants - inclusion criteria 1. Children and adolescents with a chronic disease
2. Aged 8 - 18 years old, either sex
3. Parents visiting the outpatient clinic of one of the five participating hospitals
Participants - exclusion criteria 1. Children receiving special education are excluded, because intellectual disabilities require an adapted program to overcome their communicative difficulties
2. Families will not be excluded based on ethnicity, but participants should be able to fill in Dutch questionnaires
Anticipated start date 01/11/2009
Anticipated end date 01/12/2011
Status of trial Completed
Patient information material Can be found at: http://www.amc.nl/upload/teksten/ekz/folder%20Samen%20Op%20Koers%20mei%202009.pdf (Dutch only)
Target number of participants 162
Interventions Op Koers is based on techniques proven to be effective in behavioural and cognitive behavioural programs in children with somatic complaints and in children with behaviour and/or anxiety disorders. Four learning goals are central in Op Koers:
1. Information seeking and information giving about the disease ('good to know better' principle)
2. Use of relaxation during stressful situations (using exercises)
3. Enhancement of social competence (group discussions, role playing)
4. Positive thinking (effective use of the Thinking-Feeling-Doing model; replacement of inaccurate thoughts)

The parent intervention 'Samen op Koers' is built on existing cognitive behavioural programs for parents of children with anxiety problems. 'Samen op Koers' fits into the learning goals of Op Koers. The program combines cognitive behavioural strategies with parenting behaviour training, focusing on positive responsiveness and autonomy granting, including:
1. Promoting and supporting children's acquisition of novel self-help skills
2. Labelling and accepting children's emotional responses (rather than criticising them)
3. Allowing children to struggle and learn by trial and error rather than taking over for them
4. Giving choices (rather than making choices for the children)

The primary purpose of the parental module is enhancing treatment effects of the children's program, by teaching parents to encourage their children in using the learned strategies. The secondary goal of Samen op Koers is to encourage parents to take a positive attitude towards granting autonomy to their children, so that children will actually receive the opportunity to exercise their learned skills by themselves. Overall, the parent interventions are intended to enhance availability of parental support as perceived by the children, expected to result in increases in children's perceived self-efficacy and in the implementation of coping skills, related to their disease and treatment, which in turn will improve social-emotional functioning in children with chronic illnesses (CI).

The total duration of treatment is 6 weeks and the total duration of follow-up is one year.
Primary outcome measure(s) Social emotional functioning, measured using the Child Behaviour Check List (CBCL), and the Strengths and Difficulties Questionnaire (SDQ). Assessments will be at baseline, post-treatment and at six months and 12 months follow-up.
Secondary outcome measure(s) Assessments will be at baseline, post-treatment and at six months and 12 months follow-up:
1. Health related quality of life (KIDSREEN/DISABKIDS instruments)
2. Self perception (Self-Perception Profile for Children)
3. Copings skills (Coping Skills Inventory [CSI])
4. Parental stress (NOSIK instrument)
5. Parent-child interaction
6. Perceived vulnerability (Child Vulnerabilty Scale)
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 80-82435-98-8038)
Trial website http://www.opkoersonline.nl
Publications 1. 2011 study design in http://www.ncbi.nlm.nih.gov/pubmed/21756299
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23478870
Contact name Prof  Bob F  Last
  Address Academic Medical Center (AMC)
Emma Children's Hospital
Psychosocial Department
Room G8-224
P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Tel +31 (0)20 566 56 74
  Fax +31 (0)20 609 12 42
  Email b.f.last@amc.nl
Sponsor The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
  Address Postbox 93 245
  City/town The Hague
  Zip/Postcode 2509 AE
  Country Netherlands
  Sponsor website: http://www.zonmw.nl
Date applied 02/10/2009
Last edited 22/05/2013
Date ISRCTN assigned 13/11/2009
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