Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
When a child is diagnosed with cancer, this entails a crisis for the parents, a traumatic situation that can cause both immediate and long-term psychological stress. Therapy programmes offered to parents during the year following the cancer diagnosis may help them to manage the psychological stresses associated with the child’s illness and treatment. Our aim is to study whether crisis therapy intervention conducted by experienced professionals can help parents cope with their child’s illness, reducing levels of traumatic stress caused by the diagnosis and treatment. We shall also study the possible influence of various socio-demographic factors (parents’ age, sex, education, child’s cancer type) on the findings.

Who can participate?
Parents of a child recently diagnosed with cancer at the childhood cancer centre at Astrid Lindgren Children’s Hospital in Stockholm.

What does the study involve?
Parents are randomly allocated to an intervention group or a control group. At the beginning of the study period, all parents are asked to fill in a questionnaire in order to gauge the levels of distress they may be experiencing in relation to their child’s recently diagnosed illness. They will be asked to fill in same questionnaire once the intervention programme is over, to see whether distress levels have changed since the first occasion when distress was assessed. Parents in the intervention group are offered face to face, 90 minute sessions with the intervention staff. Participation begins shortly after the child’s diagnosis and the programme will be concluded within 12 months. Parents in the control group will not take part in the study intervention, only in the assessments of distress. For both groups, assessments of distress take place at similar points in time from the child’s diagnosis.

What are the possible benefits and risks of participating?
The study focuses on a sensitive period - the first year following a child’s cancer – so addressing parents’ thoughts and feelings associated with the experience may be accompanied by discomfort and emotional pain. At the same time, evidence shows that therapy can be helpful when facing emotional pain and stress, providing parents with support and strength in coping with their child’s illness.

Where is the study run from?
Karolinska Institutet (Sweden).

When is study starting and how long is it expected to run for?
The study ran from October 2000 to March 2005.

Who is funding the study?
The study is funded by The Swedish Childhood Cancer Foundation and The Cancer and Traffic Injury Foundation, Sweden.

Who is the main contact?
Assoc. Professor Krister K Boman

Trial website

Contact information



Primary contact

Prof Krister K Boman


Contact details

Karolinska Institutet
Department of Women’s and Children’s Health
Childhood Cancer Research Unit
Astrid Lindgren Children’s Hospital Q6:05

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Crisis intervention for parents of children with newly diagnosed cancer: development, implementation and assessment of efficacy of a model for treatment of distress and traumatic stress symptoms in a randomised controlled trial where post-intervention distress symptom levels of cases are compared with those of controls receiving standard treatment as usual


Study hypothesis

1. Is participation in the crisis intervention for parents of children with newly diagnosed cancer associated with less severe psychological symptoms measured post-intervention compared to outcomes of controls receiving only treatment as usual (TAU)?
2. Is the decrease in distress/stress greater among parents offered CIP-CC (Crisis Intervention Program for parents with Children with newly diagnosed Cancer) compared to TAU.
3. How do CIP-CC participants experience and evaluate the CIP-CC?

We hypothesised that participants in the intervention would display less severe symptoms post-intervention than parents receiving TAU

Ethics approval

The Karolinska Institute Ethics Committee, Stockholm, 21/10/1999, ref: dnr 99-240

Study design

Single-centre randomised clinical open-label trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Post-traumatic stress, anxiety, depression


CIP-CC program: manual-guided, structured and time-limited psychological crisis intervention. Duration: 12 months

Control: treatment as usual, consisting of standard routine psychosocial attention of the treatment unit.

Total duration of follow-up: approximately 13 months

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. Illness-specific distress and generic symptoms of anxiety and depression assesed using the standardised 'Parental Psychosocial Distress in Cancer' (PPD-C) - a 125 item self-report instrument
2. Traumatic and post-traumatic stress assessed using the standardised 'Impact of Events Scale - revised' (IES-R) - a 22-item self-report instrument

Assessed at baseline and follow-up.

Secondary outcome measures

For intervention participants:
1. The Client Satisfaction Questionnaire (CSQ-8) to assess participants unitary general satisfaction
2. Evaluation of efficacy and feasibility of the CIP-CC program

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Parents of a child with a recent primary cancer diagnosis (i.e. newly diagnosed)
2. The child registered at the study treatment center

Participant type


Age group




Target number of participants

Approximately 350

Participant exclusion criteria

1. Child registered for treatment of a relapse
2. Child suffering from a known 100% fatal malignancy
3. Child in a palliative treatment stage
4. Parent does not speak Swedish

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Karolinska Institutet

Sponsor information


Swedish Childhood Cancer Foundation (Sweden)

Sponsor details

PO box 5408

Sponsor type




Funder type


Funder name

Swedish Childhood Cancer Foundation (Sweden), ref: PROJ98/006

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Swedish Cancer and Traffic Injury Fund (Sweden), ref: C 20002

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes