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Risk and Resilience Factors in Learning Disabilities Population

This study is currently recruiting participants.
Verified June 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01652651
First received: June 17, 2012
Last updated: July 25, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to report preliminary outcomes of executive function and psychopathology symptoms of a manual-based psychological intervention for adolescents diagnosed with learning disorders- I can succeed (ICS).


Condition Intervention
Learning Disorders
 Behavioral: I Can Succeed ICS

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Contribution of Risk and Resilience Factors in Learning Disabilities Population to Academic and Emotional Development

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Change in Child Behavior Checklist (CBCL) (Achenbach, 1991). [ Time Frame: base line (time 0) and end of treatment (3 month) ] [ Designated as safety issue: No ]
    The Child Behavior Checklist (CBCL) is a device by which parents and teachers rate a child's problem behaviors and competencies. It consists of 112 behavioral items (and 1 open-ended item) scored on a 3-step response scale from Not true (0) to Very true or Often true (2). Subscales include Aggressive Behavior, Anxious/Depressed, Attention Problems, Delinquent Rule-Breaking Behavior, Social Problems, Somatic Complaints, Thought Problems, Withdrawn, Externalizing, Internalizing, Total Problems, plus DSM-oriented scales.


Secondary Outcome Measures:
  • Change in The standardized Brain Resource cognition assessment, ''IntegNeuro,'' (Clark et al., 2006). [ Time Frame: base line (time 0) and end of treatment (3 month) ] [ Designated as safety issue: No ]
    A computerized standardized assessment of Executive Functions and Continuous Performance Test


Estimated Enrollment: 70
Study Start Date: May 2009
Estimated Study Completion Date: December 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychological Intervention Behavioral: I Can Succeed ICS
ICS is a manual-based psychological intervention aimed to address both emotional and academic-executive functions aspects of LD.It consists of acute phase (13 once a week sessions) and follow-up phase (6 sessions over 18 months). ICS focuses on developing intrapersonal skills (e.g. self awareness, goal setting, organizational skills), interpersonal skills (e.g. communication, problem solving)and school/community skills (i.e. strengthening the family-school relationship) (Kopelman-Rubin et al., 2011).

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Learning Disorder diagnosis
  • Normal range IQ
  • Regular class attendance

Exclusion Criteria:

  • Suicidal ideation and psychosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652651

Contacts
Contact: Daphne Kopelman-Rubin, Ph.D +972-9-9549497 daphnekr@idc.ac.il

Locations
Israel
Schneider Children Medical Center of Israel Recruiting
Petah Tikva, Israel, 49202
Contact: Daphne Kopelman-Rubin, Ph.D     +972-9-9549497     Daphnekr@idc.ac.il    
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Daphne Kopelman-Rubin, Ph.D Schneider's Children Medical Center of Israel
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01652651     History of Changes
Other Study ID Numbers: 5383
Study First Received: June 17, 2012
Last Updated: July 25, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
Learning Disorders

Additional relevant MeSH terms:
Learning Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013