Risk and Resilience Factors in Learning Disabilities Population

Learning Disorders Clinical Trial

Official title:

The Contribution of Risk and Resilience Factors in Learning Disabilities Population to Academic and Emotional Development

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01652651
• Other study ID #: 5383
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2012
• Last updated: July 25, 2012
• Start date: May 2009
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: Rabin Medical Center
• Contact: Daphne Kopelman-Rubin, Ph.D
• Phone: +972-9-9549497
• Email: daphnekr[@]idc.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 15 Years

Eligibility

Inclusion Criteria:

• Learning Disorder diagnosis

• Normal range IQ

• Regular class attendance

Exclusion Criteria:

• Suicidal ideation and psychosis

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Learning Disorders

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).

Locations

Country	Name	City	State
Israel	Schneider Children Medical Center of Israel	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	base line (time 0) and end of treatment (3 month)	No
Secondary	Change in The standardized Brain Resource cognition assessment, ''IntegNeuro,'' (Clark et al., 2006).	A computerized standardized assessment of Executive Functions and Continuous Performance Test	base line (time 0) and end of treatment (3 month)	No