Learning DisordersNCT01652651
Risk and Resilience Factors in Learning Disabilities Population
A study testing I Can Succeed ICS in people with Learning Disorders, run by Rabin Medical Center at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning Disorders
- What is being tested?
- I Can Succeed ICS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Learning Disorder diagnosis
- Normal range IQ
- Regular class attendance
Who cannot join
- Suicidal ideation and psychosis
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children Medical Center of Israel
Petah Tikva, 49202
Daphne Kopelman-Rubin, Ph.D, +972-9-9549497, Daphnekr@idc.ac.il
About this study
Official title: 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).
- Conditions
- Learning Disorders
- Being tested
- I Can Succeed ICS
- Keywords
- Learning Disorders
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I Can Succeed ICSBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention | Experimental | Not described Receives: Behavioral: I Can Succeed ICS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
A computerized standardized assessment of Executive Functions and Continuous Performance Test
Measured: base line (time 0) and end of treatment (3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startMay 2009
- Primary completionApr 2012
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daphne Kopelman-Rubin, Ph.D, Principal investigator, Schneider's Children Medical Center of Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652651
- Sponsor's protocol ID
- 5383
- Status last verified
- Jun 2012
- First submitted
- 17 Jun 2012
- Last updated
- 30 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Risk and Resilience Factors in Learning Disabilities Population to Academic and Emotional Development
- ClinicalTrials.gov ID
- NCT01652651
- Acronym / sponsor ID
- 5383
- Conditions
- Learning Disorders
- Keywords
- Learning Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention | Experimental | Behavioral: I Can Succeed ICS |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Learning Disorder diagnosis
- Normal range IQ
- Regular class attendance
Key exclusion criteria (1 listed)
- Suicidal ideation and psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I Can Succeed ICSICS 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). | Behavioural | Psychological Intervention |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daphne Kopelman-Rubin, Ph.D principal investigator
Schneider's Children Medical Center of Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I Can Succeed ICS in people with Learning Disorders, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daphne Kopelman-Rubin, Ph.D (+972-9-9549497, daphnekr@idc.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Behavior Checklist (CBCL) (Achenbach, 1991). (time frame: base line (time 0) and end of treatment (3 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.