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TRICCS: Targeting Inattention in Childhood Cancer Survivors

8 Years
16 Years
Not Enrolling
Childhood Cancer

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Trial Information

TRICCS: Targeting Inattention in Childhood Cancer Survivors

After obtaining written informed consent (parent) and assent (child), screening procedures
will include administration of an abbreviated intellectual test battery, a working memory
battery, and a computerized attention measure to the survivor (see specific Measures below).
Our goal is to enroll 24 (12 ALL, 12 brain tumor) participants in the intervention phase of
this prospective pilot study. To reach this goal, we anticipate needing to screen
approximately 50 survivors, though enrollment will end when, or continue until, 24 eligible
participants are identified and randomized to the intervention phase. Parents will complete
questionnaire measures regarding their child's adaptive, behavioral, emotional, and
attentional functioning. Follow-up interviewing will be conducted to clarify any potential
problems identified on the questionnaires. The entire screening procedure is estimated to
take approximately 90 minutes for the survivor and 30-45 minutes for parents. To maximize
efficiency, two study personnel will work with families - one will complete testing with the
child, while the other will complete questionnaires and follow-up interviewing with the
parent. The design will be a double-blind, placebo-controlled trial in which half of the
participants will be randomized to the intervention condition and half will receive a
comparison computer program. Specifically, participants assigned to the comparison
(placebo) condition will complete a modified version of the CT at home. The treatment and
comparison CT programs begin identically, at the lowest difficulty level. Those in the
treatment condition will complete activities of increasing difficulty over the intervention
period. Those in the placebo condition, in contrast, will complete the same basic tasks
during each session of the intervention, regardless of performance. In this way, a true
estimate can be obtained of the efficacy of the treatment program.

Inclusion Criteria:

1. A T-score greater than the 75th percentile on either the Cognitive
Problems/Inattention or the DSM-IV Inattention subscales of the Conners' Parent
Rating Scale

2. One or more standard deviations below the mean on the Attention or Working Memory
Indices of the WRAML 2 [56] or Attention or Working Memory Indices that are one or
more standard deviations below the participant's estimated IQ. These criteria are
similar to those used in a trial of methylphenidate with survivors of childhood

Exclusion Criteria:

1. Estimated IQ ≤ 70

2. A motor, visual, or auditory handicap that prevents computer use

3. A diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant
Disorder, depression, autism, or Pervasive Developmental Disorder

4. Insufficient fluency in English. Participants who are currently taking stimulant
medications (stable dose for at least 30 days) for attentional difficulties, but who
meet inclusion criteria listed below will be allowed to participate.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:


Outcome Time Frame:

2 months and 3 months

Safety Issue:


Principal Investigator

Kristi Hardy, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:




Start Date:

December 2007

Completion Date:

November 2012

Related Keywords:

  • Childhood Cancer
  • Pediatric
  • Brain Tumor
  • Acute Lymphoblastic Leukemia
  • Inattention
  • Childhood cancer survivors



Duke University Medical Center Preston Robert Tisch Brain Tumor Center Durham, North Carolina  27710