NCT03559712

Brief Summary

Aim and objectives: In this study, our goal is to assess the effectiveness of a collaborative tele-mental health approach for treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) presenting to primary healthcare centers in Dubai. Our primary aim is: To determine if collaborative tele-mental health program improves the clinical and functional outcomes for children with Attention-deficit/hyperactivity disorder (ADHD) in Dubai Secondary aims:

  1. 1.To improve the ability of primary health-care providers to diagnose and treat pediatric ADHD, leading to enhanced community capacity, improving patient access and ensuring sustainability.
  2. 2.To enhance parent and child satisfaction with the ADHD assessment and treatment process in Dubai.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

June 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

May 24, 2018

Last Update Submit

June 19, 2018

Conditions

ADHDTelemental Health

Keywords

Attention Deficit Hyperactivity DisorderCollaborative CareTelemedecineTelemental Health

Outcome Measures

Primary Outcomes (1)

  • NIHCQ Vanderbilt assessment scale (Parent)

    Change in Total Symptom Score for ADHD symptoms in Vanderbilt parent informant form and follow-up forms (at 3 and 6-months follow-up)

    At baseline, 3-month follow-up and 6-month follow-up

Study Arms (2)

Telemedicine

EXPERIMENTAL

Participants in this arm will be treated by the trained primary health care physicians in the primary health care centers, who will be having weekly supervisions with the specialists for case management.

Other: Collaborative care, Telemental health

Control

NO INTERVENTION

Participants in this arm will experience treatment as usual, which means referral to a specialist.

Interventions

Collaborative care, Telemental healthOTHER

Children who are referred to the collaborative tele-mental health care arm, Arm (1), will be given a follow-up appointment with the physician at the same primary care center who have successfully completed the pre-trial didactic program designed by Drs. Albanna and Hamoda. The trained child health physician will conduct assessments, treat and manage the patient. All while having weekly clinical supervision with the specialist.

Telemedicine

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children ages 6-12 years
  • Children who meet DSM-5 criteria for ADHD as determined by both clinical assessment and the Vanderbilt ADHD scales.

You may not qualify if:

  • Active clinically significant medical illness (e.g. cardiac and seizure disorders).
  • Family history of early onset cardiac disease.
  • Autism spectrum disorder or clinically significant developmental delay.
  • Intellectual disability (IQ of 70 and below, or diagnosis of intellectual disability).
  • Active primary psychiatric illness other than ADHD (e.g. mood disorder, anxiety disorder, psychotic disorder, tic disorder).
  • Previous ADHD diagnosis and treatment.
  • Currently taking psychiatric medications for any indication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dubai Health Authority

Dubai, 4545, United Arab Emirates

RECRUITING

Al Jalila Children's Specialty Hospital

Dubai, United Arab Emirates

NOT YET RECRUITING

Related Publications (5)

  • Eapen V, Mabrouk AA, Zoubeidi T, et al. (2009) Epidemiological Study of Attention Deficit Hyperactivity Disorder Among School Children in the United Arab Emirates. HAMDAN MEDICAL JOURNAL, 2(3):119-127-127. doi:10.2174/1996327000902030119

    BACKGROUND

  • Myers K, Vander Stoep A, Lobdell C. Feasibility of conducting a randomized controlled trial of telemental health with children diagnosed with attention-deficit/hyperactivity disorder in underserved communities. J Child Adolesc Psychopharmacol. 2013 Aug;23(6):372-8. doi: 10.1089/cap.2013.0020.

    PMID: 23952183BACKGROUND

  • Myers K, Vander Stoep A, Zhou C, McCarty CA, Katon W. Effectiveness of a telehealth service delivery model for treating attention-deficit/hyperactivity disorder: a community-based randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2015 Apr;54(4):263-74. doi: 10.1016/j.jaac.2015.01.009. Epub 2015 Jan 29.

    PMID: 25791143BACKGROUND

  • Silverstein M, Hironaka LK, Walter HJ, Feinberg E, Sandler J, Pellicer M, Chen N, Cabral H. Collaborative care for children with ADHD symptoms: a randomized comparative effectiveness trial. Pediatrics. 2015 Apr;135(4):e858-67. doi: 10.1542/peds.2014-3221.

    PMID: 25802346BACKGROUND

  • Epstein JN, Langberg JM, Lichtenstein PK, Altaye M, Brinkman WB, House K, Stark LJ. Attention-deficit/hyperactivity disorder outcomes for children treated in community-based pediatric settings. Arch Pediatr Adolesc Med. 2010 Feb;164(2):160-5. doi: 10.1001/archpediatrics.2009.263.

    PMID: 20124145BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Ammar AlBanna, MD FRCPC IFAPA

CONTACT

00971502030000aalbanna@ajch.ae

Karina Soubra, MSc

CONTACT

00971506241550karina.soubra@ajch.ae

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Using a collaborative care approach with the aid of telemedicine to treat children with ADHD
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Child and Adolescent Mental Health Center of Excellence, Consultant Child and Adolescent Psychiatrist

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 18, 2018

Study Start

June 7, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

June 20, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

AE(2)