Mental DisordersPhase 2/3SCT-ABINCT00692081
Social Competence Training for Adolescents With Borderline Intellectual Functioning
A Phase 2/3 study testing Social competence training and Special vocational training in people with Mental Disorders, run by University of Ulm.
Trial summary
Emotional and behavioural problems as well as a lack of social competence are supposed to be common phenomena in adolescents with borderline intellectual functioning, consequently impairing their social and vocational integration. Read more about this study
- Who is it for?
- Ages 16 to 23 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Social competence training and Special vocational training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 16 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 16 - 23 years
- participating in special vocational training program
- elevated scores in a screening measure of behavioral/emotional disorders (CBCL or YSR T>59)
Who cannot join
- major psychiatric disorder (psychosis, major depression, substance abuse)
About this study
Official title: A Randomized Controlled Trial of a Social Competence Group Training for Adolescents With Borderline Intellectual Functioning
Emotional and behavioural problems as well as a lack of social competence are supposed to be common phenomena in adolescents with borderline intellectual functioning, consequently impairing their social and vocational integration. Considering the lack of evaluated group interventions for this population, a cognitive-behavioural training is developed and its effectiveness is examined in a population of students attending special vocational schools.
77 adolescents with borderline intelligence are enrolled participated in the study. They are randomized either to the intervention group, who received 9 group sessions over a period of 3 months additionally to the standard vocational training (Social Competence Training for Adolescents with Borderline Intelligence, SCT-ABI) or to the control group who received only the standard vocational training. Outcome measures at the end of the intervention and at a 6-months follow-up assessment comprise self-reports, caregiver-reports, and behavioural observations of cognitive, emotional, and behavioural factors of social competence.
- Conditions
- Mental Disorders
- Being tested
- Social competence training, Special vocational training
- Keywords
- adolescents, borderline intellectual functioning, social competence training, vocational training, group intervention, cognitive behavioral therapy, Adolescents with borderline intellectual functioning
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social competence trainingBehavioural
8 group sessions multi-modal social competence training, 2-4 hours each, 2 trainers, 6-10 participants
Special vocational trainingBehavioural
as provided in German special centres for vocational training
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 8 group sessions social competence training (CBT) Receives: Behavioral: Social competence training |
| B | Active comparator | special vocational training as usual Receives: Behavioral: Special vocational training |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Investigators
- Lutz Goldbeck, Ph.D., Principal investigator, University Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692081
- Sponsor's protocol ID
- UNIVULM
- Acronym
- SCT-ABI
- Status last verified
- Jun 2008
- First submitted
- 4 Jun 2008
- Last updated
- 6 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Nestler J, Goldbeck L. A pilot study of social competence group training for adolescents with borderline intellectual functioning and emotional and behavioural problems (SCT-ABI). J Intellect Disabil Res. 2011 Feb;55(2):231-41. doi: 10.1111/j.1365-2788.2010.01369.x. Epub 2011 Jan 4.
PubMed 21199047
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Social Competence Group Training for Adolescents With Borderline Intellectual Functioning
- ClinicalTrials.gov ID
- NCT00692081
- Acronym / sponsor ID
- SCT-ABI / UNIVULM
- Conditions
- Mental Disorders
- Keywords
- adolescents, borderline intellectual functioning, social competence training, vocational training, group intervention, cognitive behavioral therapy, Adolescents with borderline intellectual functioning
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- First posted
- 6 Jun 2008 (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.
Emotional and behavioural problems as well as a lack of social competence are supposed to be common phenomena in adolescents with borderline intellectual functioning, consequently impairing their social and vocational integration. Considering the lack of evaluated group interventions for this population, a cognitive-behavioural training is developed and its effectiveness is examined in a population of students attending special vocational schools.
77 adolescents with borderline intelligence are enrolled participated in the study. They are randomized either to the intervention group, who received 9 group sessions over a period of 3 months additionally to the standard vocational training (Social Competence Training for Adolescents with Borderline Intelligence, SCT-ABI) or to the control group who received only the standard vocational training. Outcome measures at the end of the intervention and at a 6-months follow-up assessment comprise self-reports, caregiver-reports, and behavioural observations of cognitive, emotional, and behavioural factors of social competence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Social competence training8 group sessions social competence training (CBT) |
| B | Active comparator | Behavioral: Special vocational trainingspecial vocational training as usual |
Who may qualify
- Ages
- 16 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 16 - 23 years
- participating in special vocational training program
- elevated scores in a screening measure of behavioral/emotional disorders (CBCL or YSR T>59)
Key exclusion criteria (1 listed)
- major psychiatric disorder (psychosis, major depression, substance abuse)
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 |
|---|---|---|
| Social competence training8 group sessions multi-modal social competence training, 2-4 hours each, 2 trainers, 6-10 participants | Behavioural | A |
| Special vocational trainingas provided in German special centres for vocational training | Behavioural | B |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2008.
- Derived from this study: PubMed 21199047Nestler J, Goldbeck L. A pilot study of social competence group training for adolescents with borderline intellectual functioning and emotional and behavioural problems (SCT-ABI). J Intellect Disabil Res. 2011 Feb;55(2):231-41. doi: 10.1111/j.1365-2788.2010.01369.x. Epub 2011 Jan 4.
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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.
Lutz Goldbeck, Ph.D. principal investigator
University Ulm
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Social competence training and Special vocational training in people with Mental Disorders, run by University of Ulm.
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: finished, as of the sponsor's last update on 6 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692081, which also lists 1 linked publication.
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 6 Jun 2008.