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Clinical Trials/NCT03559712
NCT03559712UnknownNot Applicable

Effectiveness of Collaborative Tele-Mental Health Services for ADHD in Primary Care: A Randomized Trial in Dubai (ECTSAP- Dubai Trial)

Al Jalila Children's Specialty Hospital2 sites in 1 country122 target enrollmentStarted: June 7, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
122
Locations
2
Primary Endpoint
NIHCQ Vanderbilt assessment scale (Parent)

Study Overview

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. 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. To enhance parent and child satisfaction with the ADHD assessment and treatment process in Dubai.

Detailed Description

Potential Significance:

There are presently very limited clinical resources for children with ADHD, a prevalent disorder associated with significant functional impairments across different domains. Given the large number of affected children and their families, and the lack of readily available resources, very long wait-lists exist delaying access to healthcare. This is especially important given that ADHD occurs during a critical period of child development. Despite that effective treatments for ADHD do exist, it is quite challenging to deliver timely interventions to children with ADHD. This study aims to assess the efficacy of an innovative collaborative care approach that significantly improves access to evidence based health services and builds capacity in the community. Given that public healthcare services in Dubai are open to all emirates in the UAE and that some specialized services are lacking in other emirates, such a program that utilizes a virtual platform will facilitate healthcare access to this group of children in remote areas. After providing evidence for its feasibility and efficacy, this approach is likely to then be implemented across Dubai's Health Authority and to become a model that can be implemented nationally and regionally.

This study will significantly enhance the capacity of primary care physicians in Dubai, UAE to provide clinical care for children with common mental health conditions, namely ADHD. Enhancing the capacity of the Primary care sector to assess and treat this disorder in collaboration with the center of excellence at Al Jalila Children's is expected to improve access to clinical care while assuring optimal care is provided.

Moreover, it will improve the expertise of the center of excellence in child mental health at Al Jalila children's through clinical and research collaboration with Boston Children's Hospital. This study might open the doors for future collaborations with international institute such Boston Children's which will result in improved pediatric care at Al Jalila Children's. After providing evidence for its feasibility and efficacy, this approach is likely to then be implemented across Dubai's Health Authority and to become a model that can be implemented nationally and regionally.

Methods:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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.

Arms & Interventions

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.

Intervention: Collaborative care, Telemental health (Other)

Control

No Intervention

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

Outcomes

Primary Outcomes

NIHCQ Vanderbilt assessment scale (Parent)

Time Frame: At baseline, 3-month follow-up and 6-month follow-up

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Ammar AlBanna

Head of Child and Adolescent Mental Health Center of Excellence, Consultant Child and Adolescent Psychiatrist

Al Jalila Children's Specialty Hospital

Study Sites (2)

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