Attention Deficit Hyperactivity DisorderNCT01176136
Organizational Skills Interventions for Children With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Homework, Organization, and Planning Skills (HOPS) Intervention in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed childhood disorders, with prevalence rates estimated at 8% (Froehlich et al. 2007). Several of the primary symptoms of ADHD relate to problems with temporal and materials organization (i.e. Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Homework, Organization, and Planning Skills (HOPS) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 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 11 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Middle school age adolescents (grades 6-8) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a diagnosis of ADHD.
Who cannot join
- Cognitive Functioning: Full scale IQ score of less than 75.
- Exclusionary Psychiatric Conditions: Students who meet diagnostic criteria for Bipolar Disorder, psychotic disorder, pervasive developmental disorders, substance dependence, or obsessive-compulsive disorder be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
About this study
Official title: Organizational Skills Interventions for Children With ADHD
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed childhood disorders, with prevalence rates estimated at 8% (Froehlich et al. 2007). Several of the primary symptoms of ADHD relate to problems with temporal and materials organization (i.e. often has difficulty organizing tasks and activities, often loses things, is often forgetful, and often fails to finish school-work, chores, or duties; APA, 2000). In the school setting, problems with organization manifest as forgetting to complete or losing homework assignments, difficulties planning for the completion of long-term projects and studying for tests, and problems keeping class materials organized. These organizational difficulties become particularly problematic in middle school and can result in considerable academic impairment (Evans, Serpell, \& White, 2005). Children with ADHD underachieve academically and are more likely than their peers to receive failing grades, be retained and to drop out of school (Barkley, Fischer, Edelbrock, \& Smallish, 1990).
Given the relationship between temporal and materials organization and poor school performance, it is clear there is a need for interventions to address these difficulties. We recently sought to address this need by completing a small randomized trial of an organizational skills intervention for children with ADHD (Langberg, Epstein, Urbanowicz, Simon, \& Graham, (2008). The intervention was highly effective in improving materials organization and homework management and resulted in significant improvements in homework problems and grade point average. These results demonstrate the considerable promise of organizational skills interventions for children with ADHD. However, the Langberg et al. intervention was implemented as an after-school program operated by research staff with minimal involvement from school personnel. In order to promote the widespread adoption of interventions that address the organizational skills deficits of children with ADHD, the intervention must be feasible for school counselors and psychologists to implement within the time constraints of a typical school day. Accordingly, the primary goal of this study is to adapt and refine the existing intervention protocol (Langberg et al., 2008) to create a product that is highly acceptable to parents, children, teachers, school counselors and school psychologists and is feasible for school personnel to implement during the school day.
Read more
In Phase I of the proposed research, middle school counselors, psychologists, teachers, middle school students with ADHD and their parents will consult with the intervention developers to modify the after-school treatment protocol for in-school implementation. An intervention protocol will be developed. The intervention will be piloted with ten children in order to identify barriers to implementation. Measures of treatment fidelity, skills acquisition, and satisfaction will be completed. These data will inform additional modifications of the protocol and further improve feasibility/acceptability of the intervention procedures.
In Phase II of the study, school counselors/psychologists from at least four separate school districts will implement the protocol developed in Phase I. Using a waitlist control design, sixty children with ADHD in grades 6, 7, and 8 will receive the intervention. Organizational skills, grade point average, and academic impairment will be evaluated at baseline, post intervention and at 8-week follow-up. After implementing the intervention, all participants (i.e., teachers, counselors, psychologists, children and parents) will participate in a series of focus groups and will complete intervention satisfaction questionnaires. These data will inform final revisions to the intervention protocol. The resulting product will be an intervention that targets organizational skills in children with ADHD that has potential for widespread school-based dissemination. The final intervention protocol and effect size estimates from the proposed research will lay the foundation for an IES Goal III test of efficacy.
The specific aims of the project are as follows:
- Utilize the existing organizational skills intervention protocol (Langberg et al. in press), focus group and case study data to develop an empirically and clinically informed manualized temporal and materials organization intervention for middle school children with ADHD aimed at reducing academic impairment (Phase I).
- Refine and finalize the intervention protocol through a waitlist control trial (N=60) in a minimum of four diverse school districts, collection of clinical outcomes and completion of follow-up focus groups to assess satisfaction, feasibility, and acceptability (Phase II).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Homework, Organization, and Planning Skills (HOPS) Intervention
- Keywords
- ADHD, School-Based, Organizational Skills, Homework, Time Management
- 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.
Homework, Organization, and Planning Skills (HOPS) InterventionBehavioural
HOPS is a 16 session school-based intervention. School counselors and psychologists deliver the intervention during the school day. Each session lasts 20 minutes. Initially, sessions are 2 times per week and the entire HOPS intervention is completed in 11 weeks. The study uses a waitlist control design. HOPS intervention participants (Arm 1) receive the intervention in the fall quarter of the school year and Treatment As Usual participants (Arm 2) receive the intervention in the spring quarter.
| Study group | Role | What they receive |
|---|---|---|
| HOPS Intervention | Experimental | Middle school age children who receive the Homework, Organization, and Planning Skills (HOPS) intervention. Receives: Behavioral: Homework, Organization, and Planning Skills (HOPS) Intervention |
| Treatment As Usual | No intervention | Middle school age children randomly assigned to receive treatment-as-usual services available through the school and community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homework Problems Checklist
Parent completed measure that assesses homework completion difficulties and homework management difficulties.
Measured: 8 months post-baseline
Secondary outcomes (1)
Children's Organizational Skills Scales (COSS)
Parent, child, and teacher completed measure that evaluates organization and time-management/planning skills.
Measured: 8-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua M Langberg, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176136
- Sponsor's protocol ID
- 2009-0479
- Other IDs
- R305A090305
- Status last verified
- Jul 2013
- First submitted
- 12 Jul 2010
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organizational Skills Interventions for Children With ADHD
- ClinicalTrials.gov ID
- NCT01176136
- Acronym / sponsor ID
- 2009-0479
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, School-Based, Organizational Skills, Homework, Time Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Aug 2010 (estimated)
- 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.
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed childhood disorders, with prevalence rates estimated at 8% (Froehlich et al. 2007). Several of the primary symptoms of ADHD relate to problems with temporal and materials organization (i.e. often has difficulty organizing tasks and activities, often loses things, is often forgetful, and often fails to finish school-work, chores, or duties; APA, 2000). In the school setting, problems with organization manifest as forgetting to complete or losing homework assignments, difficulties planning for the completion of long-term projects and studying for tests, and problems keeping class materials organized. These organizational difficulties become particularly problematic in middle school and can result in considerable academic impairment (Evans, Serpell, \& White, 2005). Children with ADHD underachieve academically and are more likely than their peers to receive failing grades, be retained and to drop out of school (Barkley, Fischer, Edelbrock, \& Smallish, 1990).
Given the relationship between temporal and materials organization and poor school performance, it is clear there is a need for interventions to address these difficulties. We recently sought to address this need by completing a small randomized trial of an organizational skills intervention for children with ADHD (Langberg, Epstein, Urbanowicz, Simon, \& Graham, (2008). The intervention was highly effective in improving materials organization and homework management and resulted in significant improvements in homework problems and grade point average. These results demonstrate the considerable promise of organizational skills interventions for children with ADHD. However, the Langberg et al. intervention was implemented as an after-school program operated by research staff with minimal involvement from school personnel. In order to promote the widespread adoption of interventions that address the organizational skills deficits of children with ADHD, the intervention must be feasible for school counselors and psychologists to implement within the time constraints of a typical school day. Accordingly, the primary goal of this study is to adapt and refine the existing intervention protocol (Langberg et al., 2008) to create a product that is highly acceptable to parents, children, teachers, school counselors and school psychologists and is feasible for school personnel to implement during the school day.
In Phase I of the proposed research, middle school counselors, psychologists, teachers, middle school students with ADHD and their parents will consult with the intervention developers to modify the after-school treatment protocol for in-school implementation. An intervention protocol will be developed. The intervention will be piloted with ten children in order to identify barriers to implementation. Measures of treatment fidelity, skills acquisition, and satisfaction will be completed. These data will inform additional modifications of the protocol and further improve feasibility/acceptability of the intervention procedures.
In Phase II of the study, school counselors/psychologists from at least four separate school districts will implement the protocol developed in Phase I. Using a waitlist control design, sixty children with ADHD in grades 6, 7, and 8 will receive the intervention. Organizational skills, grade point average, and academic impairment will be evaluated at baseline, post intervention and at 8-week follow-up. After implementing the intervention, all participants (i.e., teachers, counselors, psychologists, children and parents) will participate in a series of focus groups and will complete intervention satisfaction questionnaires. These data will inform final revisions to the intervention protocol. The resulting product will be an intervention that targets organizational skills in children with ADHD that has potential for widespread school-based dissemination. The final intervention protocol and effect size estimates from the proposed research will lay the foundation for an IES Goal III test of efficacy.
The specific aims of the project are as follows:
- Utilize the existing organizational skills intervention protocol (Langberg et al. in press), focus group and case study data to develop an empirically and clinically informed manualized temporal and materials organization intervention for middle school children with ADHD aimed at reducing academic impairment (Phase I).
- Refine and finalize the intervention protocol through a waitlist control trial (N=60) in a minimum of four diverse school districts, collection of clinical outcomes and completion of follow-up focus groups to assess satisfaction, feasibility, and acceptability (Phase II).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOPS Intervention | Experimental | Behavioral: Homework, Organization, and Planning Skills (HOPS) InterventionMiddle school age children who receive the Homework, Organization, and Planning Skills (HOPS) intervention. |
| Treatment As Usual | No intervention | –Middle school age children randomly assigned to receive treatment-as-usual services available through the school and community. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Middle school age adolescents (grades 6-8) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a diagnosis of ADHD.
Key exclusion criteria (2 listed)
- Cognitive Functioning: Full scale IQ score of less than 75.
- Exclusionary Psychiatric Conditions: Students who meet diagnostic criteria for Bipolar Disorder, psychotic disorder, pervasive developmental disorders, substance dependence, or obsessive-compulsive disorder be excluded from participation.
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 |
|---|---|---|
| Homework, Organization, and Planning Skills (HOPS) InterventionHOPS is a 16 session school-based intervention. School counselors and psychologists deliver the intervention during the school day. Each session lasts 20 minutes. Initially, sessions are 2 times per week and the entire HOPS intervention is completed in 11 weeks. The study uses a waitlist control design. HOPS intervention participants (Arm 1) receive the intervention in the fall quarter of the school year and Treatment As Usual participants (Arm 2) receive the intervention in the spring quarter. | Behavioural | HOPS Intervention |
Primary outcome
Homework Problems Checklist
Time frame: 8 months post-baseline
Parent completed measure that assesses homework completion difficulties and homework management difficulties.
1 secondary outcome
Children's Organizational Skills Scales (COSS)
Time frame: 8-months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
Related trials for Attention Deficit Hyperactivity Disorder
RecruitingObservational study
National Pregnancy Registry for Psychiatric Medications
Pregnant Women, Psychotropic Drugs
Recruiting
Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
Attention Deficit Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
ADHD
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.
Joshua M Langberg, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homework, Organization, and Planning Skills (HOPS) Intervention in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati 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 1 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 30 Jul 2013. 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?
Homework Problems Checklist (time frame: 8 months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2013.