Attention Deficit Disorder With HyperactivityNCT00895908
Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children
A study testing Friendship Group and Academic tutoring in people with Attention Deficit Disorder With Hyperactivity, run by Penn State University.
Trial summary
This study will determine the effectiveness of an intervention for preventing at-risk kindergarten and pre-kindergarten children from developing attention deficit hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Friendship Group and Academic tutoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2009to 30 Apr 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical or subclinical levels of ADHD symptomatology, based upon teacher and parent report
Who cannot join
- Presence of sensorimotor disability, frank neurological disorder, or psychosis
- Estimated Full Scale Intelligence Quotient (FSIQ) less than 70
- Very low levels of English proficiency that preclude completion of the assessment battery
- In a temporary custody situation with uncertain outcome
About this study
Official title: Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills
This study will determine the effectiveness of an intervention for preventing at-risk kindergarten and pre-kindergarten children from developing attention deficit hyperactivity disorder.
Read the detailed description
Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsiveness, and hyperactivity. ADHD is not commonly diagnosed until a child has entered formal schooling and shown academic and behavioral adjustment difficulties, but developmental research suggests that risk factors for developing ADHD are evident earlier. A significant number of children start school with high levels of disorganized and inattentive behaviors, which are symptoms of emerging ADHD. This study will test an intervention aimed at preventing the development of ADHD by identifying those at risk for developing ADHD in kindergarten and pre-kindergarten and teaching them self-regulation skills through socialization. These skills have been associated with school success, and they may reduce the likelihood of children developing ADHD.
Participation in this study will last for 4 months, with a follow-up assessment after 1 year. To enroll, child participants will undergo a screening process that will include assessments by their teachers and parents. Eligible child participants will also be assessed by researchers in a classroom setting. They will then be randomly assigned to receive either a play-based intervention, called the Friendship Group, or an individual pre-academic tutoring intervention. Both groups will meet at school. The Friendship Group, which will focus on strengthening attention and self-regulation through social skills, will involve 30 sessions twice a week for 15 weeks. The tutoring intervention, which will focus on strengthening academic skills, will involve one or two sessions a week for 4 months. Participants will be assessed at three time points: pre-intervention, post-intervention, and after 1 year. Assessments will include teacher ratings and direct testing of child attention, language, and pre-academic skills.
- Being tested
- Friendship Group, Academic tutoring
- Keywords
- ADHD, Psychosocial Intervention, Social Skills Training
- 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.
Friendship GroupBehavioural
Social skills training for 30 sessions, held twice per week over 4 to 5 months
Academic tutoringBehavioural
Tutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months
| Study group | Role | What they receive |
|---|---|---|
| Friendship Group Intervention | Experimental | Participants will receive the "Friendship Groups" intervention. Receives: Behavioral: Friendship Group |
| Individual Tutoring | Active comparator | Participants will receive individual academic tutoring. Receives: Behavioral: Academic tutoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention deficit hyperactivity disorder (ADHD) symptomatology
Measured: Measured pre- and post-treatment and at 12-month follow-up
Secondary outcomes (1)
Social competence
Measured: Measured pre- and post-treatment and at 12-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 posted8 May 2009 (estimated)
- Study start1 Jul 2009
- Primary completion30 Apr 2012
- Study completion30 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of social skill training intervention with active attention control group (academic tutoring)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Karen Bierman, Penn State University
- Investigators
- Karen L. Bierman, PhD, Principal investigator, The Pennsylvannia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895908
- Sponsor's protocol ID
- R34MH085889
- Other IDs
- R34MH085889, DDTR B2-MBT
- Status last verified
- Mar 2017
- First submitted
- 7 May 2009
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills
- ClinicalTrials.gov ID
- NCT00895908
- Acronym / sponsor ID
- R34MH085889
- Keywords
- ADHD, Psychosocial Intervention, Social Skills Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 30 Apr 2012 (actual)
- Study completion
- 30 Apr 2013 (actual)
- First posted
- 8 May 2009 (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.
This study will determine the effectiveness of an intervention for preventing at-risk kindergarten and pre-kindergarten children from developing attention deficit hyperactivity disorder.
Detailed description
Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsiveness, and hyperactivity. ADHD is not commonly diagnosed until a child has entered formal schooling and shown academic and behavioral adjustment difficulties, but developmental research suggests that risk factors for developing ADHD are evident earlier. A significant number of children start school with high levels of disorganized and inattentive behaviors, which are symptoms of emerging ADHD. This study will test an intervention aimed at preventing the development of ADHD by identifying those at risk for developing ADHD in kindergarten and pre-kindergarten and teaching them self-regulation skills through socialization. These skills have been associated with school success, and they may reduce the likelihood of children developing ADHD.
Participation in this study will last for 4 months, with a follow-up assessment after 1 year. To enroll, child participants will undergo a screening process that will include assessments by their teachers and parents. Eligible child participants will also be assessed by researchers in a classroom setting. They will then be randomly assigned to receive either a play-based intervention, called the Friendship Group, or an individual pre-academic tutoring intervention. Both groups will meet at school. The Friendship Group, which will focus on strengthening attention and self-regulation through social skills, will involve 30 sessions twice a week for 15 weeks. The tutoring intervention, which will focus on strengthening academic skills, will involve one or two sessions a week for 4 months. Participants will be assessed at three time points: pre-intervention, post-intervention, and after 1 year. Assessments will include teacher ratings and direct testing of child attention, language, and pre-academic skills.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparison of social skill training intervention with active attention control group (academic tutoring)
| Arm | Type | Receives |
|---|---|---|
| Friendship Group Intervention | Experimental | Behavioral: Friendship GroupParticipants will receive the "Friendship Groups" intervention. |
| Individual Tutoring | Active comparator | Behavioral: Academic tutoringParticipants will receive individual academic tutoring. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical or subclinical levels of ADHD symptomatology, based upon teacher and parent report
Key exclusion criteria (4 listed)
- Presence of sensorimotor disability, frank neurological disorder, or psychosis
- Estimated Full Scale Intelligence Quotient (FSIQ) less than 70
- Very low levels of English proficiency that preclude completion of the assessment battery
- In a temporary custody situation with uncertain outcome
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 |
|---|---|---|
| Friendship GroupSocial skills training for 30 sessions, held twice per week over 4 to 5 months | Behavioural | Friendship Group Intervention |
| Academic tutoringTutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months | Behavioural | Individual Tutoring |
Primary outcome
Attention deficit hyperactivity disorder (ADHD) symptomatology
Time frame: Measured pre- and post-treatment and at 12-month follow-up
1 secondary outcome
Social competence
Time frame: Measured pre- and post-treatment and at 12-month follow-up
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 10 Mar 2017.
- 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.
Karen L. Bierman, PhD principal investigator
The Pennsylvannia State University
Questions about this trial
What is this clinical trial studying?
A study testing Friendship Group and Academic tutoring in people with Attention Deficit Disorder With Hyperactivity, run by Penn State University.
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 4 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Attention deficit hyperactivity disorder (ADHD) symptomatology (time frame: Measured pre- and post-treatment and at 12-month follow-up). 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 10 Mar 2017.