A manualised preventive counselling program for children of parents with cancer

ISRCTN ISRCTN34770541
DOI https://doi.org/10.1186/ISRCTN34770541
Protocol serial number N/A
Sponsor German Cancer Aid (Deutsche Krebshilfe e.V.) (Germany)
Funder German Cancer Aid (Deutsche Krebshilfe) (Germany)
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

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

Study information

Primary study designInterventional
Study designSingle centre randomised waiting list controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA randomised controlled trial of a manualised preventive counselling program for children of parents with cancer
Study acronymRCT COSIP
Study objectivesEvaluation 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) studiedChild and adolescent psychotherapy and psychiatry, psycho-oncology
InterventionA 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 typeOther
Primary outcome measure(s)

1. Children’s health-related quality of life with Kid-Screen (8-18 years) rated from children’s and parents’ view.
2. Children’s 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 children’s view

Key secondary outcome measure(s)

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 children’s and adolescents (exposure through children’s 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 children’s and adolescent’s 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’, children’s (over 11 years) and counsellors’ viewpoint

Completion date30/03/2011
Reason abandoned (if study stopped)Participant recruitment issues

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Key inclusion criteria1. Wishing/seeking support
2. At least one parent has cancer
3. At least one child between 0-21 years
Key exclusion criteria1. 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 enrolment07/12/2009
Date of final enrolment30/03/2011

Locations

Countries of recruitment

  • Germany

Study participating centre

University Medical Centre Hamburg-Eppendorf
Hamburg
20246
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes
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