Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Birgit Moeller
ORCID ID
Contact details
University Medical Centre Hamburg-Eppendorf
Centre of Psychosocial Medicine
Department of Child and Adolescent Psychiatry and Psychotherapy
Martinistrasse 52
Hamburg
20246
Germany
+49 (0)40 7410 52243
bmoeller@uke.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial of a manualised preventive counselling program for children of parents with cancer
Acronym
RCT COSIP
Study hypothesis
Evaluation of interventions effectiveness compared to waiting list control of a manualised child-focused preventive counselling program for children of parents with cancer.
Ethics approval
Ethics Committee of the Medical Association of Hamburg gave approval on October 15, 2009; (ref: PV3322)
Study design
Single centre randomised waiting list controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Child and adolescent psychotherapy and psychiatry, psycho-oncology
Intervention
A manualised child-focused preventive counselling program consisting of
1. Evaluation of parent(s)
2. Evaluation of child or children
3. A maximum of six individually customised and focused sessions (e.g. further single sessions with one or each child or a parent alone, sessions with family, parents or siblings)
All outcomes will be measured before and after treatment, and at 6 month follow up
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Childrens health-related quality of life with Kid-Screen (8-18 years) rated from childrens and parents view.
2. Childrens behavioural and emotional problems measured with Child Behaviour Checklist (1,5-5/ 6-18 years) rated from parents view and Youth Self Report (11-18 years) rated from childrens view
Secondary outcome measures
1. Parents self-rated anxiety and depression measured with Hospital Anxiety and Depression Scale (HADS)
2. Family Assessment Device (FAD) to measure familial functioning from parents perspective
3. Family Crisis-Oriented Personal Evaluation Scales (F-COPES) to measure familial coping behaviour in crisis situations
4. Freiburg Questionnaire of Coping with Illness (FKV) to measure parental coping with illness
5. Health Survey (SF-8) to measure parental quality of life
6. Strengths and Difficulties Questionnaire (SDQ) to measure childrens and adolescents (exposure through childrens self-rating and additionally parents view
7. Connor-Davidson Resilience Scale (CD-Risc) to measure six different resilience factors
8. Kid-Cope (13-18 years) to measure childrens and adolescents cognitive and behavioural coping with parents cancer disease
9. Ad hoc developed intervention program rating scales to evaluate specific intervention contents and satisfaction with intervention; ratings from parents, childrens (over 11 years) and counsellors viewpoint
Overall trial start date
07/12/2009
Overall trial end date
30/03/2011
Reason abandoned
Participant recruitment issues
Eligibility
Participant inclusion criteria
1. Wishing/seeking support
2. At least one parent has cancer
3. At least one child between 0-21 years
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
140 families
Participant exclusion criteria
1. Neither parent has cancer (e. g. other chronic diseases)
2. No informed consent for study participation (the program is provided without study participation)
3. At least one parent has psychotic symptoms or a psychotic mental disorder (ICD-10 or DSM-IV)
4. Acute endangerment of child to self or others
5. Insufficient German language abilities
6. Insufficient mobility of ill parent (the program is then offered to other family members)
Recruitment start date
07/12/2009
Recruitment end date
30/03/2011
Locations
Countries of recruitment
Germany
Trial participating centre
University Medical Centre Hamburg-Eppendorf
Hamburg
20246
Germany
Sponsor information
Organisation
German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany)
Sponsor details
Buschstr. 32
Bonn
53113
Germany
+49 (0)228 729900
deutsche@krebshilfe.de
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
German Cancer Aid (Deutsche Krebshilfe) (Germany)
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
Results - basic reporting
Publication summary