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Risk and Resilience Factors in Learning Disabilities Population

Primary Purpose

Learning Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
I Can Succeed ICS
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Learning Disorders focused on measuring Learning Disorders

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Suicidal ideation and psychosis

Sites / Locations

  • Schneider Children Medical Center of IsraelRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychological Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in Child Behavior Checklist (CBCL) (Achenbach, 1991).
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Attention Problems, Delinquent Rule-Breaking Behavior, Social Problems, Somatic Complaints, Thought Problems, Withdrawn, Externalizing, Internalizing, Total Problems, plus DSM-oriented scales.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).
A computerized standardized assessment of Executive Functions and Continuous Performance Test

Full Information

First Posted
June 17, 2012
Last Updated
July 25, 2012
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01652651
Brief Title
Risk and Resilience Factors in Learning Disabilities Population
Official Title
The Contribution of Risk and Resilience Factors in Learning Disabilities Population to Academic and Emotional Development
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Learning Disorders
Keywords
Learning Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychological Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
I Can Succeed ICS
Intervention Description
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 Measure Information:
Title
Change in Child Behavior Checklist (CBCL) (Achenbach, 1991).
Description
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.
Time Frame
base line (time 0) and end of treatment (3 month)
Secondary Outcome Measure Information:
Title
Change in The standardized Brain Resource cognition assessment, ''IntegNeuro,'' (Clark et al., 2006).
Description
A computerized standardized assessment of Executive Functions and Continuous Performance Test
Time Frame
base line (time 0) and end of treatment (3 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Learning Disorder diagnosis Normal range IQ Regular class attendance Exclusion Criteria: Suicidal ideation and psychosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne Kopelman-Rubin, Ph.D
Phone
+972-9-9549497
Email
daphnekr@idc.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphne Kopelman-Rubin, Ph.D
Organizational Affiliation
Schneider's Children Medical Center of Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children Medical Center of Israel
City
Petah Tikva
ZIP/Postal Code
49202
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daphne Kopelman-Rubin, Ph.D
Phone
+972-9-9549497
Email
Daphnekr@idc.ac.il

12. IPD Sharing Statement

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Risk and Resilience Factors in Learning Disabilities Population

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