NCT00917189

Brief Summary

This study will test a computer-based treatment for youth with the genetic disorder velocardiofacial syndrome (VCFS) to help them improve skills in memory, attention, and executive functioning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

5.6 years

First QC Date

June 8, 2009

Last Update Submit

October 20, 2016

Conditions

Keywords

VCFSChromosome 22q Deletion SyndromeLearning Disorders

Outcome Measures

Primary Outcomes (1)

  • The California Learning Test and the Visual Span Test

    Measured immediately following the intervention at each phase

Secondary Outcomes (1)

  • Performance on the Apartment Test

    Measured immediately following the intervention at each phase

Study Arms (1)

Computerized Cognitive Skills Training

EXPERIMENTAL

Participants will receive the Challenging Our Minds intervention, delivered in-person in Phase 1 and remotely in Phases 2 and 3.

Behavioral: Challenging Our Minds Program

Interventions

A computerized cognitive intervention that provides training in attention, memory, and executive function

Computerized Cognitive Skills Training

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of velocardiofacial syndrome (VCFS)
  • IQ score between 70 and 90

You may not qualify if:

  • Presence of psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (2)

  • Mariano MA, Tang K, Kurtz M, Kates WR. Examining the durability of a hybrid, remote and computer-based cognitive remediation intervention for adolescents with 22q11.2 deletion syndrome. Early Interv Psychiatry. 2018 Aug;12(4):686-693. doi: 10.1111/eip.12367. Epub 2016 Sep 15.

  • Mariano MA, Tang K, Kurtz M, Kates WR. Cognitive remediation for adolescents with 22q11 deletion syndrome (22q11DS): a preliminary study examining effectiveness, feasibility, and fidelity of a hybrid strategy, remote and computer-based intervention. Schizophr Res. 2015 Aug;166(1-3):283-9. doi: 10.1016/j.schres.2015.05.030. Epub 2015 Jun 1.

MeSH Terms

Conditions

DiGeorge SyndromeLearning Disabilities

Condition Hierarchy (Ancestors)

22q11 Deletion SyndromeCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesLymphatic AbnormalitiesLymphatic DiseasesHemic and Lymphatic DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornHypoparathyroidismParathyroid DiseasesEndocrine System DiseasesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Wendy R. Kates, PhD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 21, 2016

Record last verified: 2016-10

Locations