ADHD - Combined Type Clinical Trial
Official title:
A School-Based Intervention to Improve Social Functioning in Children and Adolescents With ADHD: A Pragmatic Randomized Controlled Trial Comparing Standard and Enriched Provision.
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | September 1, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Behandlingsskolerne | Vanløse | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Behandlingsskolerne |
Denmark,
Barkley RA, Fischer M. The unique contribution of emotional impulsiveness to impairment in major life activities in hyperactive children as adults. J Am Acad Child Adolesc Psychiatry. 2010 May;49(5):503-13. — View Citation
Daley D, van der Oord S, Ferrin M, Danckaerts M, Doepfner M, Cortese S, Sonuga-Barke EJ; European ADHD Guidelines Group. Behavioral interventions in attention-deficit/hyperactivity disorder: a meta-analysis of randomized controlled trials across multiple outcome domains. J Am Acad Child Adolesc Psychiatry. 2014 Aug;53(8):835-47, 847.e1-5. doi: 10.1016/j.jaac.2014.05.013. Epub 2014 Jun 26. Review. — View Citation
DuPaul, G. J., Power, T. J., Anastopoulos, A. D., & Reid, R. (1998). ADHD Rating Scale-IV: Checklists, Norms, and Clinical Interpretation. New York: Guilford.
Gol D, Jarus T. Effect of a social skills training group on everyday activities of children with attention-deficit-hyperactivity disorder. Dev Med Child Neurol. 2005 Aug;47(8):539-45. — View Citation
Harrison, P.L., & Oakland, T. (2003), Adaptive Behavior Assessment System - Second Edition, San Antonio, TX: The Psychological Corporation)
Jensen PS, Hinshaw SP, Kraemer HC, Lenora N, Newcorn JH, Abikoff HB, March JS, Arnold LE, Cantwell DP, Conners CK, Elliott GR, Greenhill LL, Hechtman L, Hoza B, Pelham WE, Severe JB, Swanson JM, Wells KC, Wigal T, Vitiello B. ADHD comorbidity findings from the MTA study: comparing comorbid subgroups. J Am Acad Child Adolesc Psychiatry. 2001 Feb;40(2):147-58. — View Citation
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. — View Citation
MTA Cooporativ Group (1999) The Multimodal Treatment of Attention Deficit Hyperactivity Disorder Study, funded by National Institute of Mental Health. JAMA Psychiatry.
Niclasen J, Teasdale TW, Andersen AM, Skovgaard AM, Elberling H, Obel C. Psychometric properties of the Danish Strength and Difficulties Questionnaire: the SDQ assessed for more than 70,000 raters in four different cohorts. PLoS One. 2012;7(2):e32025. doi: 10.1371/journal.pone.0032025. Epub 2012 Feb 27. — View Citation
Sonuga-Barke EJ, Brandeis D, Cortese S, Daley D, Ferrin M, Holtmann M, Stevenson J, Danckaerts M, van der Oord S, Döpfner M, Dittmann RW, Simonoff E, Zuddas A, Banaschewski T, Buitelaar J, Coghill D, Hollis C, Konofal E, Lecendreux M, Wong IC, Sergeant J; European ADHD Guidelines Group. Nonpharmacological interventions for ADHD: systematic review and meta-analyses of randomized controlled trials of dietary and psychological treatments. Am J Psychiatry. 2013 Mar;170(3):275-89. doi: 10.1176/appi.ajp.2012.12070991. Review. — View Citation
van den Hoofdakker BJ, van der Veen-Mulders L, Sytema S, Emmelkamp PM, Minderaa RB, Nauta MH. Effectiveness of behavioral parent training for children with ADHD in routine clinical practice: a randomized controlled study. J Am Acad Child Adolesc Psychiatry. 2007 Oct;46(10):1263-71. — View Citation
Wigham S, McConachie H, Tandos J, Le Couteur AS; Gateshead Millennium Study core team. The reliability and validity of the Social Responsiveness Scale in a UK general child population. Res Dev Disabil. 2012 May-Jun;33(3):944-50. doi: 10.1016/j.ridd.2011.12.017. Epub 2012 Jan 25. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total score Adaptive Behavior Assesment System (ABASII) | Primary outcome will be an aggregate score on social and adaptive functioning from the assessment using ABASII (Adaptive Behavior Assessment System). The score is shown as "General Adaptive Composite" (GAC) on a scale from 60 to 140. The Mean area of GAC is found on the scale between a score 90 and 109. A GAC score from 100-140 is indicating a functionning level ranging from "better than mean" to "extremely high". A GAC score from 90-60 is indicating a functioning level ranging from "below mean" to " extremly low". |
0-12 month | |
Primary | Total score Social Responsiveness Scale (SRS) | Primary outcome will be an aggregate score on social functioning from the assessment using SRS (Social Responsiveness Scale). The score is shown as "T-Score" on a scale from 30 to 90. A T-Score below 60 indicates normal functioning in social responsiveness. A T-score between 60 and 75 indicates difficulties in a mild to moderate level. A T-Score higher than 75 indicates severe difficulties. |
0-12 month | |
Secondary | Subscale scores Strength and Difficulties Questionnaire (SDQ) on "behavioral difficulties", "getting along with other children" and "hyperactivity and concentration difficulties". | Secondary outcome will be using subscale scores of strength and difficulties using SDQ (Strength and Difficulties Qustionnaire). The SDQ has 25 items on an ordinal scale: Not true Partly true True Each Item is scored in a range from 0-10 indicating the level of difficulties. |
0-12 month | |
Secondary | Total score Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) | Secondary outcome will be a an aggregate score of ADHD symptoms and conduct disorder using ADHD-RS (Attention Deficit Hyperactivity Disorder Rating Scale). ADHD-RS has 26 items on an ordinal scale: Rarely/Never Sometimes Often Very often The score is ranging from 0- 78 indicating the level of difficulties. |
0-12 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06465641 -
Methylphenidate in KBG Syndrome: N-of-1 Series
|
Phase 4 | |
Not yet recruiting |
NCT06081348 -
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
|
Phase 2 | |
Completed |
NCT04799886 -
Attitudes Associated to Prescription of ADHD Drugs Among Child and Adolescent Psychiatrists in Region Skåne.
|
||
Completed |
NCT04511169 -
MyADHD-digital Training for Adults With ADHD
|
N/A | |
Completed |
NCT05452954 -
Psychosocial ADHD Interventions - Brief Parent Training
|
N/A | |
Completed |
NCT01727414 -
Attention Deficit Disorder Medication Response Study
|
Phase 4 | |
Active, not recruiting |
NCT05930912 -
Psychiatric Orders in Psychoanalytic Treatment of ASD
|
||
Recruiting |
NCT05924594 -
Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301
|
Phase 3 | |
Recruiting |
NCT04781972 -
Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
|
Phase 4 | |
Active, not recruiting |
NCT05286762 -
Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301
|
Phase 3 | |
Not yet recruiting |
NCT06235177 -
Psychoneuromentalism Disorder: A Medical Condition That Affects People With Psychological Impairments From Health Issues
|
Early Phase 1 | |
Recruiting |
NCT04504890 -
Ocular-vestibular Biomarker Identification for ADHD
|
||
Recruiting |
NCT06299189 -
A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care
|
N/A | |
Recruiting |
NCT04729439 -
Technology-Enhanced Executive Functioning Intervention for ADHD
|
Phase 1 | |
Completed |
NCT03335748 -
the Cogmed Program for Youths With ADHD
|
N/A | |
Completed |
NCT05631626 -
Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.
|
Phase 3 |