- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01652651
Risk and Resilience Factors in Learning Disabilities Population
July 25, 2012 updated by: Rabin Medical Center
The Contribution of Risk and Resilience Factors in Learning Disabilities Population to Academic and Emotional Development
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).
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Petah Tikva, Israel, 49202
- Recruiting
- Schneider Children Medical Center of Israel
-
Contact:
- Daphne Kopelman-Rubin, Ph.D
- Phone Number: +972-9-9549497
- Email: Daphnekr@idc.ac.il
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Learning Disorder diagnosis
- Normal range IQ
- Regular class attendance
Exclusion Criteria:
- Suicidal ideation and psychosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychological Intervention
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
base line (time 0) and end of treatment (3 month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
base line (time 0) and end of treatment (3 month)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daphne Kopelman-Rubin, Ph.D, Schneider's Children Medical Center of Israel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
April 1, 2012
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
June 17, 2012
First Submitted That Met QC Criteria
July 25, 2012
First Posted (Estimate)
July 30, 2012
Study Record Updates
Last Update Posted (Estimate)
July 30, 2012
Last Update Submitted That Met QC Criteria
July 25, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5383
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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