NCT01652651

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 30, 2012

Status Verified

June 1, 2012

Enrollment Period

2.9 years

First QC Date

June 17, 2012

Last Update Submit

July 25, 2012

Conditions

Keywords

Learning Disorders

Outcome Measures

Primary Outcomes (1)

  • 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Attention Problems, Delinquent Rule-Breaking Behavior, Social Problems, Somatic Complaints, Thought Problems, Withdrawn, Externalizing, Internalizing, Total Problems, plus DSM-oriented scales.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)

Secondary Outcomes (1)

  • Change in The standardized Brain Resource cognition assessment, ''IntegNeuro,'' (Clark et al., 2006).

    base line (time 0) and end of treatment (3 month)

Study Arms (1)

Psychological Intervention

EXPERIMENTAL
Behavioral: I Can Succeed ICS

Interventions

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).

Psychological Intervention

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Suicidal ideation and psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children Medical Center of Israel

Petah Tikva, 49202, Israel

RECRUITING

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Daphne Kopelman-Rubin, Ph.D

    Schneider's Children Medical Center of Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne Kopelman-Rubin, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2012

First Posted

July 30, 2012

Study Start

May 1, 2009

Primary Completion

April 1, 2012

Study Completion

December 1, 2013

Last Updated

July 30, 2012

Record last verified: 2012-06

Locations