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Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children

7. marts 2017 opdateret af: Karen Bierman, Penn State University

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.

Studieoversigt

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

Interventionel

Tilmelding (Faktiske)

171

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

4 år til 7 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Karen L. Bierman, PhD, The Pennsylvannia State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2009

Primær færdiggørelse (Faktiske)

30. april 2012

Studieafslutning (Faktiske)

30. april 2013

Datoer for studieregistrering

Først indsendt

7. maj 2009

Først indsendt, der opfyldte QC-kriterier

7. maj 2009

Først opslået (Skøn)

8. maj 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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