ADHDECTSAPNCT03559712
Effectiveness of Collaborative Tele-Mental Health Services for ADHD in Primary Care
A study testing Collaborative care, Telemental health in people with ADHD and Telemental Health, run by Al Jalila Children's Specialty Hospital at 2 sites in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD, Telemental Health
- What is being tested?
- Collaborative care, Telemental health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 7 Jun 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 6-12 years
- Children who meet DSM-5 criteria for ADHD as determined by both clinical assessment and the Vanderbilt ADHD scales.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites, 2 recruiting
- Recruiting
Dubai Health Authority
Dubai, 4545
Fatma AlOlama, Dr, 00971554569777, fmalolama@dha.gov.ae
Elize Thottumkal, elizegt@dha.gov.ae
- Not yet recruiting
Al Jalila Children's Specialty Hospital
Dubai
Ammar AlBanna, 00971502030000 ext. 00971502030000, aalbanna@ajch.ae
Karina Soubra, 00971506241550, karina.soubra@ajch.ae
About this study
Official title: Effectiveness of Collaborative Tele-Mental Health Services for ADHD in Primary Care: A Randomized Trial in Dubai (ECTSAP- Dubai Trial)
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.
Read more
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:
- 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.
- To enhance parent and child satisfaction with the ADHD assessment and treatment process in Dubai.
Read the 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:
An individually randomized controlled trial with 2 equal groups will be conducted. Children aged 6-12 years who are referred to their primary care provider for an ADHD assessment and meet inclusion criteria will be randomized to intervention and control arms.
The intervention will consist of treatment of children with ADHD by physicians trained by study staff on the assessment and treatment of ADHD. This training will be delivered over two stages:
In stage (1), prior to any clinical interaction with patients, physicians will attend an on-site clinical training that includes didactic teaching on ADHD including reviewing clinical guidelines and hands-on assessment and treatment of children with ADHD presenting to the tertiary care hospital (minimum of 35 hours). Drs. Albanna and Hamoda will deliver this training. Participants will be expected to successfully complete two PDM exam stations (Phenomenology, Diagnosis and Management). These PDM stations will be developed by AA and HH and will not include real patients. This educational intervention will be delivered prior to any interaction between pediatricians and patients, and only those pediatricians that successfully complete the course will participate in the collaborative-care arm of the study.
In stage (2) of the training program, an ongoing module will be developed by Drs. Albanna and Hamoda using a virtual-classroom setup. This will include monthly live online presentations presented by Drs. Albanna and Hamoda as well as invited guest speakers for select topic, that Drs. Albanna and Hamoda will moderate. This intends to discuss advanced topics and challenges that may be facing the clinicians involved in the study. The research coordinator will assure that the technical setup is prepared for the seminars. There will be a total of 8 presentations, and the duration will be 1 and half hours for each presentation. The topics will focus on various advanced aspects of managing ADHD in primary healthcare. Pre-presentation reading material will be emailed to the attendees along with details regarding the time and topic of the presentation. They will be asked to log-on 15 minutes prior and the last 30 minutes will be dedicated to discussions and questions relevant to the topic. Every presentation will be followed by 10 MCQs prepared by the presenter. Participants will also have weekly supervision meetings via video-conferencing. Randomization will occur when children with suspected ADHD present to PHCs participating in this study. Children will be randomly referred to one of these two study arms:
Arm (1): Children in this arm will received a collaborative mental health model of care by physicians who underwent the training above. Children and their families will be assessed and managed by these physicians, at the same primary care center they present at, using international guidelines. In line with the collaborative care model, physicians in this arm will have weekly supervision meetings via video-conferencing with specialists from the study team. Case management will be provided via trained allied professional or nurse. Case management will entail assuring that patients present on time for scheduled assessment and follow-ups and that questionnaires are completed and handed on time.
Arm (2): The children randomized to control arm will receive treatment as usual. This primarily consists of referral to specialized mental health services at Al Jalila Children's. They will receive assessment and management by specialists in this tertiary care center.
- Conditions
- ADHD, Telemental Health
- Being tested
- Collaborative care, Telemental health
- Keywords
- Attention Deficit Hyperactivity Disorder, Collaborative Care, Telemedecine, Telemental Health
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collaborative care, Telemental health |
| Control | No intervention | Participants in this arm will experience treatment as usual, which means referral to a specialist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At baseline, 3-month follow-up and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start7 Jun 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a collaborative care approach with the aid of telemedicine to treat children with ADHD
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Jalila Children's Specialty Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Dubai Health Authority
- Responsible party
- Principal investigator, Dr. Ammar AlBanna, Al Jalila Children's Specialty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559712
- Sponsor's protocol ID
- 027562-746845-0105
- Acronym
- ECTSAP
- Status last verified
- Jun 2018
- First submitted
- 24 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 23952183Myers 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.
PubMed 25791143Silverstein 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.
PubMed 25802346Epstein 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.
PubMed 20124145
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Collaborative Tele-Mental Health Services for ADHD in Primary Care: A Randomized Trial in Dubai (ECTSAP- Dubai Trial)
- ClinicalTrials.gov ID
- NCT03559712
- Acronym / sponsor ID
- ECTSAP / 027562-746845-0105
- Conditions
- ADHD, Telemental Health
- Keywords
- Attention Deficit Hyperactivity Disorder, Collaborative Care, Telemedecine, Telemental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Al Jalila Children's Specialty HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Dubai Health Authority
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
An individually randomized controlled trial with 2 equal groups will be conducted. Children aged 6-12 years who are referred to their primary care provider for an ADHD assessment and meet inclusion criteria will be randomized to intervention and control arms.
The intervention will consist of treatment of children with ADHD by physicians trained by study staff on the assessment and treatment of ADHD. This training will be delivered over two stages:
In stage (1), prior to any clinical interaction with patients, physicians will attend an on-site clinical training that includes didactic teaching on ADHD including reviewing clinical guidelines and hands-on assessment and treatment of children with ADHD presenting to the tertiary care hospital (minimum of 35 hours). Drs. Albanna and Hamoda will deliver this training. Participants will be expected to successfully complete two PDM exam stations (Phenomenology, Diagnosis and Management). These PDM stations will be developed by AA and HH and will not include real patients. This educational intervention will be delivered prior to any interaction between pediatricians and patients, and only those pediatricians that successfully complete the course will participate in the collaborative-care arm of the study.
In stage (2) of the training program, an ongoing module will be developed by Drs. Albanna and Hamoda using a virtual-classroom setup. This will include monthly live online presentations presented by Drs. Albanna and Hamoda as well as invited guest speakers for select topic, that Drs. Albanna and Hamoda will moderate. This intends to discuss advanced topics and challenges that may be facing the clinicians involved in the study. The research coordinator will assure that the technical setup is prepared for the seminars. There will be a total of 8 presentations, and the duration will be 1 and half hours for each presentation. The topics will focus on various advanced aspects of managing ADHD in primary healthcare. Pre-presentation reading material will be emailed to the attendees along with details regarding the time and topic of the presentation. They will be asked to log-on 15 minutes prior and the last 30 minutes will be dedicated to discussions and questions relevant to the topic. Every presentation will be followed by 10 MCQs prepared by the presenter. Participants will also have weekly supervision meetings via video-conferencing. Randomization will occur when children with suspected ADHD present to PHCs participating in this study. Children will be randomly referred to one of these two study arms:
Arm (1): Children in this arm will received a collaborative mental health model of care by physicians who underwent the training above. Children and their families will be assessed and managed by these physicians, at the same primary care center they present at, using international guidelines. In line with the collaborative care model, physicians in this arm will have weekly supervision meetings via video-conferencing with specialists from the study team. Case management will be provided via trained allied professional or nurse. Case management will entail assuring that patients present on time for scheduled assessment and follow-ups and that questionnaires are completed and handed on time.
Arm (2): The children randomized to control arm will receive treatment as usual. This primarily consists of referral to specialized mental health services at Al Jalila Children's. They will receive assessment and management by specialists in this tertiary care center.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using a collaborative care approach with the aid of telemedicine to treat children with ADHD
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: Collaborative care, Telemental healthParticipants 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. |
| Control | No intervention | –Participants in this arm will experience treatment as usual, which means referral to a specialist. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children ages 6-12 years
- Children who meet DSM-5 criteria for ADHD as determined by both clinical assessment and the Vanderbilt ADHD scales.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative care, Telemental healthChildren 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. | Other | Telemedicine |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- BackgroundEapen 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: PubMed 23952183Myers 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.
- Background: PubMed 25791143Myers 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.
- Background: PubMed 25802346Silverstein 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.
- Background: PubMed 20124145Epstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative care, Telemental health in people with ADHD and Telemental Health, run by Al Jalila Children's Specialty Hospital at 2 sites in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ammar AlBanna, MD FRCPC IFAPA (00971502030000, aalbanna@ajch.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIHCQ Vanderbilt assessment scale (Parent) (time frame: At baseline, 3-month follow-up and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03559712, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.