- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01133847
Interventions for Children With Attention and Reading Disorders (ICARD)
Reading ICARD: Interventions for Children With Attention and Reading Disorders
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45206
- Cincinnati Children's Hospital Medical Center
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- University of Texas Health Science Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Meet criteria for ADHD, Combined Type or ADHD, Predominantly Inattentive Type based on the Diagnostic Interview Schedule for Children, 4.0 (DISC) parent interview, Teacher baseline Swanson Nolan and Pelham Rating Scale (SNAP) endorses additional non-overlapping Inattentive symptoms with the parent DISC, which when combined with the parent ratings result in endorsement of 6 or more symptoms required for diagnosis by the Diagnostic and Statistical Manual.
- Have at least 4 symptoms of inattention rated "Often" or "Very Often" on the teacher version of the SNAP-IV.
- Have a standard score of 90 or lower on either the Woodcock-Johnson III Tests of Achievement Letter-Word Identification or Word Attack Subtests, or on the Basic Reading Skills Cluster
- Attend a participating school in Grades 2-5
- Have at least one parent or guardian who understands English well enough to participate in the behavioral parent training intervention.
- Have a Full Scale OR Non-Verbal Intelligence Quotient (IQ) estimate higher than 70 based on the IQ Composite and Non-Verbal IQ estimate of the Kaufman Brief Intelligence Test (KBIT-2).
Exclusion Criteria:
- Any documented or suspected bipolar disorder, severe psychosis, or other severe emotional disturbance, developmental disability, or autism.
- Receipt of primary school reading instruction in a language other than English.
- A history or presence of cardiovascular problems that would contraindicate stimulant treatment.
- Chronic vocal tics.
- Children will be excluded if they are taking a concomitant medication that has the potential to significantly affect their ADHD symptoms, that would be contraindicated to take along with the study medication, or if they have not been on a stable dose of a psychotropic medication long enough to fully assess the clinical outcome or tolerability.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Intensive Reading Instruction
Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 weeks.
The instructional approach includes an individualized combination of published programs targeting word reading and decoding; reading fluency; and reading comprehension.
|
Individualized phonologically-based instruction delivered 4 days per week for 45 min.
per day by a highly trained tutor.
|
Eksperimentel: ADHD Intervention
Carefully-managed medication and behavioral parent training.
Medication treatment begins with a four-week titration period, beginning with a trial of methylphenidate.
If benefit is insufficient or side effects are intolerable, the physician may initiate a trial of mixed salt amphetamine, followed by either Atomoxetine or Guanfacine.
When the optimum medication and dosage is determined the child returns for monthly medication maintenance visits until the end of the 16-week intervention period.
Parent training consists of nine group sessions provided by a psychologist addressing ADHD and its treatment, principals of behavior modification, and evidence-supported practices for managing behavior.
|
Appropriate dosage to be individually determined; daily for 16 weeks
Andre navne:
Nine sessions on parenting a child with ADHD
Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta
Andre navne:
Appropriate dosage to be individually determined; daily for 16 weeks
Andre navne:
Appropriate dosage to be individually determined; daily for 16 weeks
Andre navne:
|
Eksperimentel: Combined ADHD and Reading Instruction
All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 weeks. Carefully-managed medication and behavioral parent training. Medication treatment begins with a trial of methylphenidate. If benefit is insufficient or side effects are intolerable, the physician may initiate a trial of mixed salt amphetamine, followed by either Atomoxetine or Guanfacine. When the optimum medication and dosage is determined the child returns for monthly medication maintenance visits until the end of the 16-week intervention period. Parent training consists of nine group sessions on parenting a child with ADHD. |
Individualized phonologically-based instruction delivered 4 days per week for 45 min.
per day by a highly trained tutor.
Appropriate dosage to be individually determined; daily for 16 weeks
Andre navne:
Nine sessions on parenting a child with ADHD
Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta
Andre navne:
Appropriate dosage to be individually determined; daily for 16 weeks
Andre navne:
Appropriate dosage to be individually determined; daily for 16 weeks
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
Tidsramme: 16 weeks (end of Active Treatment phase), and follow-up
|
Rating Scale of ADHD symptomology completed by parents and teachers.
Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much).
The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).
|
16 weeks (end of Active Treatment phase), and follow-up
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
Tidsramme: 16 weeks (end of Active Treatment phase), and follow-up
|
Rating Scale of ADHD symptomology completed by parents and teachers.
Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much).
The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).
|
16 weeks (end of Active Treatment phase), and follow-up
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
Tidsramme: Week 16 (End of Active Treatment Phase) and Follow-Up
|
Rating Scale of ADHD symptomology completed by parents and teachers.
Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much).
The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).
|
Week 16 (End of Active Treatment Phase) and Follow-Up
|
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
Tidsramme: Week 16 (End of Active Treatment Phase) and Follow-Up
|
Rating Scale of ADHD symptomology completed by parents and teachers.
Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much).
The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).
|
Week 16 (End of Active Treatment Phase) and Follow-Up
|
Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
Tidsramme: Week 16 (End of Active Treatment Phase) and Follow-Up
|
The WIAT-III is an individually-administered test of academic achievement.
In the Word Reading subtest students read a list of increasingly difficult words.
Scores reported here are standardized scores with a mean of 100 and standard deviation of 15.
|
Week 16 (End of Active Treatment Phase) and Follow-Up
|
Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
Tidsramme: Week 16 (End of Active Treatment Phase) and Follow-Up
|
The WIAT-III is an individually-administered test of academic achievement.
In the Pseudoword Decoding subtest students read a list of increasingly difficult nonsense words as a test of their ability to use phonics to decode unknown words.
Scores reported here are standardized scores with a mean of 100 and standard deviation of 15.
Higher scores represent a better outcome.
|
Week 16 (End of Active Treatment Phase) and Follow-Up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest
Tidsramme: Week 16, End of Active Treatment Phase
|
The WIAT-III is an individually-administered test of academic achievement.
This subtest involves reading sentences and longer passages and then answering a set of literal and inferential comprehension questions about the text.
Scores reported here are standardized scores with a mean of 100 and standard deviation of 15.
Higher scores represent a better outcome.
|
Week 16, End of Active Treatment Phase
|
Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)
Tidsramme: Week 16 (End of Active Treatment Phase) and Follow-Up
|
DIBELS ORF measures oral reading fluency in connected text.
Students are presented with a passage on their grade level to read orally, and the score is the number of words of the passage read correctly in a one-minute period.
Students in this study read two passages at each test administration, and the mean score for the two passages was the dependent variable analyzed.
A research synthesis of studies reporting psychometric properties for DIBELS ORF determined that reliability coefficients in these studies exceeded .80 and that the measure demonstrated moderate to high concurrent and predictive validity across studies (Goffreda & DiPerna, 2010).
|
Week 16 (End of Active Treatment Phase) and Follow-Up
|
Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency
Tidsramme: Week 16 (End of Active Treatment Phase) and Follow-Up
|
The TOWRE Sight Word Efficiency subtest measures fluency of reading words in lists.
The raw score is the number of words or nonwords identified correctly in 45 seconds.
Standard scores with a mean of 100 and standard deviaion of 15 are reported here.
Higher scores represent a better outcome.
|
Week 16 (End of Active Treatment Phase) and Follow-Up
|
Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency
Tidsramme: Week 16 (End of Active Treatment Phase) and Follow-Up
|
The TOWRE Phonemic Decoding Efficiency measures the student's fluent decoding of nonsense words that follow the spelling rules of the English language.
The raw score is the number of nonwords identified correctly in 45 seconds.
Standardized scores with a mean of 100 and standard deviaion of 15 are reported here.
Higher scores represent a better outcome.
|
Week 16 (End of Active Treatment Phase) and Follow-Up
|
Test of Silent Reading Fluency and Comprehension (TOSREC)
Tidsramme: Week 16, End of Active Treatment Phase
|
The TOSREC measures sentence-level comprehension and silent reading fluency.
It is a sentence verification task; children are presented with a list of sentences and must tell whether they are true or false.
Items are based on common knowledge (e.g., All apples are blue).
The raw score is the number of items answered correctly in 3 minutes.
Standardized with a mean of 100 and standard deviation of 15 are reported here.
Higher scores represent a better outcome.
|
Week 16, End of Active Treatment Phase
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Carolyn A Denton, Ph.D., The University of Texas Health Science Center, Houston
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
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
- Psykiske lidelser
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Neuroadfærdsmæssige manifestationer
- Opmærksomhedsunderskud og forstyrrende adfærdsforstyrrelser
- Neuroudviklingsforstyrrelser
- Sprogforstyrrelser
- Kommunikationsforstyrrelser
- Indlæringsvanskeligheder
- Attention Deficit Disorder med hyperaktivitet
- Ordblindhed
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Autonome agenter
- Agenter fra det perifere nervesystem
- Adrenerge alfa-2-receptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Neurotransmitter optagelseshæmmere
- Membrantransportmodulatorer
- Dopaminmidler
- Dopaminoptagelseshæmmere
- Centralnervesystemets stimulanser
- Sympatomimetika
- Adrenerge optagelseshæmmere
- Methylphenidat
- Atomoxetin hydrochlorid
- Amfetamin
- Adderall
- Guanfacine
Andre undersøgelses-id-numre
- HSC-MS-09-0531
- R01HD060617 (U.S. NIH-bevilling/kontrakt)
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 .
Kliniske forsøg med Attention Deficit Hyperactivity Disorder
-
Children's National Research InstituteRekrutteringADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | TILFØJE | ADHD Overvejende uopmærksom type | ADHD - kombineret type | ADHD, overvejende hyperaktiv - impulsiv | Attention-Deficit Disorder i ungdomsårene | Attention-Deficit Hyperactivity...Forenede Stater
-
Ornit CohenUkendtAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder med hyperaktivitet | Attention Deficit Disorder | Attention Deficit Disorders med hyperaktivitet | Attention Deficit Hyperactivity DisordersIsrael
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)RekrutteringAttention-Deficit Hyperactivity DisorderForenede Stater
-
Ironshore Pharmaceuticals and Development, IncAfsluttetAttention-Deficit Hyperactivity DisorderForenede Stater
-
Florida International UniversityAfsluttetAttention-deficit/Hyperactivity DisorderForenede Stater
-
National Taiwan University HospitalUkendtAttention Deficit/Hyperactivity DisorderTaiwan
-
National Taiwan University HospitalAfsluttetAttention-deficit/Hyperactivity DisorderTaiwan
-
Purdue Pharma LPAfsluttetAttention Deficit/Hyperactivity DisorderForenede Stater
-
The Hospital for Sick ChildrenEhave; Ontario Brain InstituteAfsluttetAttention-deficit Hyperactivity DisorderCanada
-
National Taiwan University HospitalAfsluttetAttention-deficit/Hyperactivity Disorder
Kliniske forsøg med Intensive reading instruction
-
University of PennsylvaniaAfsluttetHjerte sygdom | HjertestopForenede Stater
-
Children's Hospital Medical Center, CincinnatiAktiv, ikke rekrutterendeForældre-barn relationer | Sprogudvikling | LæsefærdighedForenede Stater
-
University of California, San DiegoTilmelding efter invitationForhøjet blodtryk | Præhypertension
-
Father Flanagan's Boys' HomeRekrutteringHøretab, sensorineural | Vestibulær lidelseForenede Stater
-
National Cancer Institute (NCI)AfsluttetProstatiske neoplasmer | Prostatakræft | Neoplasmer af prostata | Prostatakræft | Stadie D0 prostatakræftForenede Stater
-
Riphah International UniversityAfsluttet
-
University of South CarolinaUniversidad de Costa Rica; Municipality of Alajuela; Agenda de MujeresAfsluttet
-
Central South UniversityJohns Hopkins Bloomberg School of Public Health; Purdue UniversityAfsluttetRygestop
-
University of AlcalaEuropean University SpainAfsluttetCerebral PareseSpanien
-
Austin Speech LabsUkendtAfasi | SprogForenede Stater