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Attention Deficit Disorder With HyperactivityCATTSNCT00830700

Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study

A study testing CATMH intervention in people with Attention Deficit Disorder With Hyperactivity, run by Seattle Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

While telemental health (TMH) programs are increasing nationally to address the inequity of access to psychiatric services, there are few reports of their efficacy, particularly with children. The current proposal will complete the second stage of our program development. Read more about this study

Who is it for?
Ages 5 to 12 years
What is being tested?
CATMH intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
223 participants
Where
1 siteUnited States
Study dates
Sep 2009to Feb 2013
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 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • is 5.5 - 12 years of age
  • resides at home with parents/relatives
  • has a dx of ADHD (CBCL DSM-oriented elevation or previous diagnosis of ADHD; C-DISC diagnosis)
  • attends school 80% of time or more (including home-schooled children)
  • speaks English or Spanish and parent speaks English or Spanish

Who cannot join

  • child has a diagnosis of: CD, OCD, psychosis, BPD, Autism, mental retardation, major medical illness
  • resident parent has a drug use problem

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Seattle Children's Hospital

    Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Telemental Health to Improve Mental Health Care and Outcomes for Children in Underserved Areas

While telemental health (TMH) programs are increasing nationally to address the inequity of access to psychiatric services, there are few reports of their efficacy, particularly with children. The current proposal will complete the second stage of our program development. In the first stage, we established the feasibility of a TMH service and its acceptability to families and PCPs. In the second stage of program development we will conduct a randomized clinical trial (RCT) that will determine whether it is possible to use technological advances to: 1) improve clinical outcomes for children with ADHD over outcomes achieved in usual PC; and 2) adhere to an EBT protocol implemented through TMH. Future studies will examine whether other types of complicated psychiatric disorders and EBTs are amenable to delivery via TMH.

The overall goal of this study is to determine whether an evidence-based model of care can be faithfully implemented when delivered using TMH to children with ADHD living in rural areas and can improve outcomes over treatment as usual (TAU) in PC. ADHD is an excellent focus for assessment of TMH, as PCPs encounter this disorder frequently, EBT guidelines are available, pharmacotherapy is the core treatment and is easily delivered in PC through videoconferencing, and stabilization may be readily achieved for most youth.

Being tested
CATMH intervention
Keywords
ADHD, telemental health, TMH, telepsychiatry, rural mental health services for children
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.

  • CATMH interventionOther

    Also called Childrens' Telemental Health Service

    This intervention is comprised of 6-tandem-sessions of pharmacotherapy and a behavioral intervention conducted over 4-5 months. The telepsychiatrist makes prescribing decisions during the intervention following consensus guidelines for ADHD treatment. The telepsychiatrist also provides education about how neurobiological deficits of ADHD relate to observed behavioral learning and difficulties. After the 6th session, the PCP resumes care of the patient. The behavioral intervention component is delivered by therapists at each participating clinic. The therapists are trained and supervised remotely by a telepsychologist . The 6-session behavioral intervention consists of approaches to managing children's behaviors and coordination with schools and other community agencies to advocate for the child.

Study groups in NCT00830700
Study groupRoleWhat they receive
CATMH interventionExperimentalChild telemental health service delivery intervention
Receives: Other: CATMH intervention
augmented TAU/PCPNo interventionAugmented treatment as usual with primary care physician

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess whether using a telemental health service delivery model effects improvement in children diagnosed with ADHD including decreased symptoms of inattention, hyperactivity, opposition and defiance and improved adaptive functioning.

    Measured: baseline, 4-, 10-, 19-, and 25-weeks

Secondary outcomes (3)

  1. Assess whether using a telemental health service delivery model improves the well-being of caregivers of children diagnosed with ADHD.

    Measured: baseline, 4-, 10-, 19- and 25-weeks

  2. Assess the ability of a telemental health service delivery model to improve treatment adherence in families of children with ADHD.

    Measured: baseline, 4-, 10-, 19- and 25-weeks

  3. Assess how reliably an evidence-based treatment protocol for the treatment of children with ADHD can be implemented within a brief telemental health service.

    Measured: baseline, 4-, 10-, 19-, and 25-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00830700
Sponsor's protocol ID
12537
Other IDs
R01MH081997 NIMH, R01MH081997
Acronym
CATTS
Status last verified
Feb 2014
First submitted
27 Jan 2009
Last updated
11 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Rockhill CM, Carlisle LL, Qu P, Vander Stoep A, French W, Zhou C, Myers K. Primary Care Management of Children with Attention-Deficit/Hyperactivity Disorder Appears More Assertive Following Brief Psychiatric Intervention Compared with Single Session Consultation. J Child Adolesc Psychopharmacol. 2020 Jun;30(5):285-292. doi: 10.1089/cap.2020.0013. Epub 2020 Mar 11.

    PubMed 32167784

  • Vander Stoep A, McCarty CA, Zhou C, Rockhill CM, Schoenfelder EN, Myers K. The Children's Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes. J Abnorm Child Psychol. 2017 Jan;45(1):27-43. doi: 10.1007/s10802-016-0155-7.

    PubMed 27117555

  • Rockhill CM, Tse YJ, Fesinmeyer MD, Garcia J, Myers K. Telepsychiatrists' Medication Treatment Strategies in the Children's Attention-Deficit/Hyperactivity Disorder Telemental Health Treatment Study. J Child Adolesc Psychopharmacol. 2016 Oct;26(8):662-671. doi: 10.1089/cap.2015.0017. Epub 2015 Aug 10.

    PubMed 26258927

  • 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.

    PubMed 25791143

  • Rockhill C, Violette H, Vander Stoep A, Grover S, Myers K. Caregivers' distress: youth with attention-deficit/hyperactivity disorder and comorbid disorders assessed via telemental health. J Child Adolesc Psychopharmacol. 2013 Aug;23(6):379-85. doi: 10.1089/cap.2013.0019.

    PubMed 23952184

  • 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 23952183

  • Vander Stoep A, Myers K. Methodology for conducting the children's attention-deficit hyperactivity disorder telemental health treatment study in multiple underserved communities. Clin Trials. 2013;10(6):949-58. doi: 10.1177/1740774513494880. Epub 2013 Jul 29.

    PubMed 23897950

Questions about this trial

What is this clinical trial studying?

A study testing CATMH intervention in people with Attention Deficit Disorder With Hyperactivity, run by Seattle Children's Hospital at 1 site in United States.

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 5 inclusion and 2 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: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess whether using a telemental health service delivery model effects improvement in children diagnosed with ADHD including decreased symptoms of inattention, hyperactivity, opposition and defiance and improved adaptive functioning. (time frame: baseline, 4-, 10-, 19-, and 25-weeks). 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 NCT00830700, which also lists 7 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 11 Feb 2014.

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