Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Bob F Last
ORCID ID
Contact details
Academic Medical Center (AMC)
Emma Children's Hospital
Psychosocial Department
Room G8-224
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 56 74
b.f.last@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZonMw: 80-82435-98-8038
Study information
Scientific title
Effectiveness of a cognitive-behavioural based group intervention for children with chronic disease: a multicentre randomised controlled trial
Acronym
Samen Op Koers
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at: http://www.amc.nl/upload/teksten/ekz/folder%20Samen%20Op%20Koers%20mei%202009.pdf (Dutch only)
Condition
Chronic illness
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 measures
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)
Overall trial start date
01/11/2009
Overall trial end date
01/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
162
Participant 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
Recruitment start date
01/11/2009
Recruitment end date
01/12/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
Postbox 93 245
The Hague
2509 AE
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 80-82435-98-8038)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Study design
Scholten L, Willemen AM, Grootenhuis MA, Maurice-Stam H, Schuengel C, Last BF, A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial., BMC Pediatr, 2011, 11, 65, doi: 10.1186/1471-2431-11-65.
-
Results
Scholten L, Willemen AM, Last BF, Maurice-Stam H, van Dijk EM, Ensink E, Zandbelt N, van der Hoop-Mooij A, Schuengel C, Grootenhuis MA, Efficacy of psychosocial group intervention for children with chronic illness and their parents., Pediatrics, 2013, 131, 4, e1196-203, doi: 10.1542/peds.2012-2222.