Know Cancer

or
forgot password

A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer: A Pilot Study


Phase 0
4 Years
10 Years
Open (Enrolling)
Both
Any Cancer Diagnosis

Thank you

Trial Information

A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer: A Pilot Study


Aim 1: Assess baseline adjustment, coping, pretend play, parenting stress, and family
interactions.

- Hypothesis 1a: Children with siblings diagnosed with cancer will have lower levels of
adjustment, coping skills, and pretend play compared to previous sample norms.

- Hypothesis 1b: The child's adjustment will be mediated by factors related to their
involvement in the sibling's medical care, such as parent's level of communication
regarding their sibling's illness, frequent isolation from the family and other social
support, time since their sibling's diagnosis, and parenting stress. -Hypothesis 1c:
Parents of children diagnosed with cancer will report higher levels of parenting stress
compared to previous sample norms.

Aim 2: Assess outcome of three play intervention sessions focusing on increasing coping and
adjustment.

- Hypothesis 2a: Compared to the active control, children in the play intervention group
will have increased coping skills after intervention.

- Hypothesis 2b: Compared to the active control, children in the play intervention group
will have better psychological adjustment following intervention.

- Hypothesis 2c: Parents of children in the play intervention group will report decreased
parenting stress following the intervention.

Once parents consent to participate and their child provides assent, they and their child
will complete the baseline questionnaires and measures. Immediately following completion of
the baseline measures, the child will be randomly assigned to either the play intervention
or active control group.Children will also be asked to rate their mood at the beginning of
each play session. The outcome parent and child questionnaires will be administered again at
a session approximately one week after the third play session, for a total of four play
sessions each spaced approximately one week apart. Children will also be asked to rate their
satisfaction with the treatment at the outcome session (e.g., "How much did you like being a
part of this study?").


Inclusion Criteria:



- Families who have had children diagnosed with any type of cancer in the past year.

- At least one sibling between the ages of 4 and 10 years old

- Patients will be targeted 1-2 months after diagnosis, but could be included in the
study up to 12 months following diagnosis.

Exclusion Criteria:

-

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Number of children with increase in coping skills after intervention

Outcome Description:

Compared to the active control, children in the play intervention group will have increased coping skills after intervention.

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Karla Fehr, M.A.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University

Authority:

United States: Institutional Review Board

Study ID:

CASE4Z11

NCT ID:

NCT01704885

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Any Cancer Diagnosis
  • Childhood Cancer
  • Sibling Play intervention
  • Sibling Behavioral Intervention
  • Siblings of Cancer Patients

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065