A manualised preventive counselling program for children of parents with cancer
| ISRCTN | ISRCTN34770541 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34770541 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/12/2009
- Registration date
- 16/12/2009
- Last edited
- 31/05/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Birgit Moeller
Scientific
Scientific
University Medical Centre Hamburg-Eppendorf
Centre of Psychosocial Medicine
Department of Child and Adolescent Psychiatry and Psychotherapy
Martinistrasse 52
Hamburg
20246
Germany
| Phone | +49 (0)40 7410 52243 |
|---|---|
| bmoeller@uke.de |
Study information
| Study design | Single centre randomised waiting list controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | A randomised controlled trial of a manualised preventive counselling program for children of parents with cancer |
| Study acronym | RCT COSIP |
| Study objectives | 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(s) | Ethics Committee of the Medical Association of Hamburg gave approval on October 15, 2009; (ref: PV3322) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 07/12/2009 |
| Completion date | 30/03/2011 |
| Reason abandoned (if study stopped) | Participant recruitment issues |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 140 families |
| Key inclusion criteria | 1. Wishing/seeking support 2. At least one parent has cancer 3. At least one child between 0-21 years |
| Key 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) |
| Date of first enrolment | 07/12/2009 |
| Date of final enrolment | 30/03/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
University Medical Centre Hamburg-Eppendorf
Hamburg
20246
Germany
20246
Germany
Sponsor information
German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany)
Charity
Charity
Buschstr. 32
Bonn
53113
Germany
| Phone | +49 (0)228 729900 |
|---|---|
| deutsche@krebshilfe.de | |
| Website | http://www.krebshilfe.de |
"ROR" |
https://ror.org/01wxdd722 |
Funders
Funder type
Charity
German Cancer Aid (Deutsche Krebshilfe) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
