A School-Based Intervention to Improve Social Functioning

NCT03313349 | Unknown DMC

• 1 other identifier: Borojonoad
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ADHD - Combined Type

Keywords

ADHD, Behavioral Problems, Children and Adolescents

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Subscale scores Strength and Difficulties Questionnaire (SDQ) on "behavioral difficulties", "getting along with other children" and "hyperactivity and concentration difficulties".

  0-12 month

• Total score Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)

  0-12 month

Study Arms (2)

Usual Provision (UP)

OTHER

Usual Provision Psychotherapy: 1. cognitive therapy 2.family intervention

Behavioral: Psychotherapy: 1. cognitive therapy 2.family intervention

Enhanced/Need-Based Provision (ENP)

OTHER

Enhanced/need-based Provision Psychotherapy: 1.cognitive therapy 2.family intervention

Behavioral: Psychotherapy: 1. cognitive therapy 2.family intervention

Interventions

Psychotherapy: 1. cognitive therapy 2.family intervention BEHAVIORAL

Psychotherapy delivered by trained psychologist for the student and the student´s parents

Enhanced/Need-Based Provision (ENP); Usual Provision (UP)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pre-existing diagnosis of ASD.
• Intellectual disability with an IQ \< 70 WISC.
• Pre-existing diagnosis of anxiety and/or depression.

Sponsors & Collaborators

• Behandlingsskolerne: lead

Study Sites (1)

Behandlingsskolerne

Vanløse, Copenhagen, 2720, Denmark

RECRUITING

Related Publications (12)

• 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. doi: 10.1097/00004583-200102000-00009.

  PMID: 11211363 BACKGROUND

• van den Hoofdakker BJ, van der Veen-Mulders L, Sytema S, Emmelkamp PMG, 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):1263-1271. doi: 10.1097/chi.0b013e3181354bc2.

  PMID: 17885567 BACKGROUND

• 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. doi: 10.1097/00004583-201005000-00011.

  PMID: 20431470 BACKGROUND

• 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.

  PMID: 25062591 BACKGROUND

• 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. doi: 10.1017/s0012162205001052.

  PMID: 16108454 BACKGROUND

• DuPaul, G. J., Power, T. J., Anastopoulos, A. D., & Reid, R. (1998). ADHD Rating Scale-IV: Checklists, Norms, and Clinical Interpretation. New York: Guilford.

  BACKGROUND

• Harrison, P.L., & Oakland, T. (2003), Adaptive Behavior Assessment System - Second Edition, San Antonio, TX: The Psychological Corporation)

  BACKGROUND

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche 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. No abstract available.

  PMID: 20332511 BACKGROUND

• MTA Cooporativ Group (1999) The Multimodal Treatment of Attention Deficit Hyperactivity Disorder Study, funded by National Institute of Mental Health. JAMA Psychiatry.

  BACKGROUND

• 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.

  PMID: 22384129 BACKGROUND

• Sonuga-Barke EJ, Brandeis D, Cortese S, Daley D, Ferrin M, Holtmann M, Stevenson J, Danckaerts M, van der Oord S, Dopfner 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.

  PMID: 23360949 BACKGROUND

• 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.

  PMID: 22277583 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Problem Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Henrik Skovlund, Phd

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo H Jacobsen, Pschologist

CONTACT

0045 28872670; boh@behandlingsskolerne.dk

Mads-frederik J Damgaard, Psychologist

CONTACT

0045 22803870; mads-frederik@behandlingsskolerne.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants in the study are allocated to each arm by using randomization system. After determining which of the three school Units the student will attend, the participants are distributed in to one of the two arms at each school (UP \& ENP). It is not possible to fully blind parents and students as they have to give informed consent. Teachers and social workers will be kept blind to allocation as far as possible . They are not directly involved in the treatment measured in this study, even though they play a great part in it. The blindness of the teachers and social workers is important as they will be providing the ratings used in the analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Psychologist

Model Details: Design: A pragmatic RCT designed according to CONSORT guidance (CONSORT, 2010) to compare UP and ENB. Students, attending the schools, were randomly allocated to either UP or ENP according to a one-to-one ratio. Outcome measures (see below) were collected at pre-intervention (T1), post-intervention (T2 - 3 months post randomization) and follow up (T3 - 6 months post randomization). If possible, the a last follow up (T4 - 12 months post randomization).

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: October 18, 2017
• Study Start: March 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)