- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00895908
Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children
Reducing ADHD by Promoting Social Collaboration and Self-Regulation Skills
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Clinical or subclinical levels of ADHD symptomatology, based upon teacher and parent report
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Friendship Group Intervention
Participants will receive the "Friendship Groups" intervention.
|
Social skills training for 30 sessions, held twice per week over 4 to 5 months
|
|
Aktiv komparator: Individual Tutoring
Participants will receive individual academic tutoring.
|
Tutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Attention deficit hyperactivity disorder (ADHD) symptomatology
Tidsramme: Measured pre- and post-treatment and at 12-month follow-up
|
Measured pre- and post-treatment and at 12-month follow-up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Social competence
Tidsramme: Measured pre- and post-treatment and at 12-month follow-up
|
Measured pre- and post-treatment and at 12-month follow-up
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Karen L. Bierman, PhD, The Pennsylvannia State University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R34MH085889 (U.S. NIH-bevilling/kontrakt)
- DDTR B2-MBT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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