Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits that interfere with learning, socialization and emotion regulation. Extensive research focused on the animal models of FXS show that targeted pharmacological agents can normalize synaptic connectivity and reverse cognitive and behavioral deficits. This translational work has led to multiple national and international controlled trials in humans with FXS now underway. However, in contrast to the heavy focus on medication treatments, there have been no controlled trials to empirically-validate cognitive or behavioral interventions for FXS. The proposed study, the first non-pharmacological controlled trial for FXS, will evaluate the efficacy of Cogmed, a cognitive training program proven to enhance working memory and executive/frontal function in a variety of clinical populations. Demonstration of effective Cogmed training for FXS would represent a major advance in the field, one that may also generalize to other forms of intellectual disability. Furthermore, it is critical to determine whether the targeted pharmacological treatments can accelerate learning and cognitive development. Thus, the validation of Cogmed for FXS will provide a paradigm for testing hypotheses focused on combined efficacy of medication and cognitive training.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
M.I.N.D. Institute, U.C. Davis
Sacramento, California, United States
Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory
Average of z scores obtained from Block Span and Leiter-R Spatial Working Memory
Time frame: 5-6 weeks
Wechsler Intelligence Scale for Children-IV Digit Span
Time frame: 5-6 weeks
Wechsler Intelligence Scale for Children-IV Digit Span
Time frame: 3 month followup
Kiddie Test of Attentional Performance (KiTAP)
Time frame: 5-6 weeks
Kiddie Test of Attentional Performance (KiTAP)
Time frame: 3 month followup
Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
Time frame: 5-6 weeks
Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
Time frame: 3 month followup
Swanson, Nolan and Pelham (SNAP-IV)
Time frame: 5-6 weeks
Swanson, Nolan and Pelham (SNAP-IV)
Time frame: 3 month followup
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