ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk and Resilience Factors in Learning Disabilities Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01652651
Recruitment Status : Unknown
Verified June 2012 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : July 30, 2012
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Learning Disorders Behavioral: I Can Succeed ICS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Contribution of Risk and Resilience Factors in Learning Disabilities Population to Academic and Emotional Development
Study Start Date : May 2009
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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).



Primary Outcome Measures :
  1. Change in Child Behavior Checklist (CBCL) (Achenbach, 1991). [ Time Frame: base line (time 0) and end of treatment (3 month) ]
    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 :
  1. 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) ]
    A computerized standardized assessment of Executive Functions and Continuous Performance Test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Suicidal ideation and psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01652651     History of Changes
Other Study ID Numbers: 5383
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: June 2012

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
Neurodevelopmental Disorders
Mental Disorders