UnknownNot Applicable

A School-Based Intervention to Improve Social Functioning

Denmark32 participantsStarted 2016-03-01

Plain-language summary

Evaluating interventions for children/adolescents with Attention Deficit Hyperactivity Disorder (ADHD) is a field that offers many challenges. Even though psychotherapeutic treatment for ADHD is recommended as the first choice in many countries(1), the evidence base for this is inconsistent and outcome specific (2). For instance, parent training may not have significant effects on the core Symptoms of ADHD (3). However, trials suggest that it facilitates skills in other areas. One area where it is of potential value is social functioning (4). The randomized controlled trial (RCT)described here will test the therapeutic value of a package of psychological interventions designed to target social functioning for children and adolescents with ADHD. It will be conducted in a special school environment designed specifically for children with severe behavioral problems. Therefore, routine provision is already substantial. As a result, it was not possible to include a "no intervention group" (control group) for ethical reasons. Therefore, the value of social skills intervention was examined by comparing different "doses" of the routine intervention by testing a usual provision (UP) group against an enriched/need-based (ENP) form of provision.

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children from 6 to 18 years old. * ADHD diagnosis from a psychiatric institution. * Diagnosis F.90.1 - Hyperkinetic behavioral disorder (ICD10), or history of behavioral problems in multiple settings (School, Home, leisure time). * Parents/caregivers with no reported mental illness or severe addictions. Exclusion Criteria: * Pre-existing diagnosis of ASD. * Intellectual disability with an IQ \< 70 WISC. * Pre-existing diagnosis of anxiety and/or depression.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total score Adaptive Behavior Assesment System (ABASII)

Timeframe: 0-12 month

Total score Social Responsiveness Scale (SRS)

Timeframe: 0-12 month

Trial details

NCT IDNCT03313349

SponsorBehandlingsskolerne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-01

Contact for this trial

Bo H Jacobsen, Pschologist

0045 28872670 boh@behandlingsskolerne.dk

View on ClinicalTrials.gov More ADHD - Combined Type trials