Clinical trial NCT01704885: A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer
Official title: A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Any Cancer Diagnosis
Keywords: Childhood Cancer
Sibling Play intervention
Sibling Behavioral Intervention
Siblings of Cancer Patients
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 5
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to determine whether a brief (three 20-30 minute session) cognitive-behavioral play intervention will improve coping skills and adjustment for siblings of children diagnosed with cancer.

Detailed description: 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?").

Eligibility criteria: 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:

-

Primary outcomes:
measure: Number of children with increase in coping skills after intervention
timeFrame: 4 weeks
measure: Number of children with better psychological adjustment following intervention
timeFrame: 4 weeks
measure: Number of parents with decreased parenting stress following intervention
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Karla Fehr, M.A.
role: PRINCIPAL_INVESTIGATOR
References: