Interventions for Children With Attention and Reading Disorders (ICARD)
2017. február 27. frissítette: Carolyn Denton, The University of Texas Health Science Center, Houston
Reading ICARD: Interventions for Children With Attention and Reading Disorders
The objective of this randomized clinical trial is to address unanswered questions about the relative effectiveness of treatments for children with both Attention Deficit Hyperactivity Disorder (ADHD) and significant reading difficulties (RD).
The study evaluates attentional and word reading outcomes for students with both conditions when provided with either (a) ADHD treatment alone, (b) RD treatment alone, or (c) the combination of ADHD and RD treatment.
A tanulmány áttekintése
Állapot
Befejezve
Részletes leírás
The objective of this randomized clinical trial is to address unanswered questions about the relative effectiveness of treatments for children with both Attention Deficit Hyperactivity Disorder (ADHD) and significant reading difficulties (RD).
The study evaluates attentional and word reading outcomes for students with both conditions when provided with either (a) disorder-specific ADHD treatment (carefully managed medication + parent training), (b) disorder-specific RD treatment (intensive, individualized reading instruction), or (c) the combination of ADHD and RD treatment.
The study aims to address the relative benefits of providing either disorder-specific ADHD or RD treatment alone and providing the combined treatment.
The investigators hypothesize that the combined treatment approach will result in better outcomes in terms of both word reading/decoding and a reduction in ADHD symptoms than either of the disorder-specific treatments alone.
Treatment will last for 16 weeks, with assessment prior to and following treatment and some measures collected regularly throughout the intervention periods.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
222
Fázis
- 4. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Ohio
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Cincinnati, Ohio, Egyesült Államok, 45206
- Cincinnati Children's Hospital Medical Center
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Texas
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Houston, Texas, Egyesült Államok, 77030
- University of Texas Health Science Center
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
7 év (Gyermek)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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.
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Individualized phonologically-based instruction delivered 4 days per week for 45 min.
per day by a highly trained tutor.
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Kísérleti: 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.
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Appropriate dosage to be individually determined; daily for 16 weeks
Más nevek:
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
Más nevek:
Appropriate dosage to be individually determined; daily for 16 weeks
Más nevek:
Appropriate dosage to be individually determined; daily for 16 weeks
Más nevek:
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Kísérleti: 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
Más nevek:
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
Más nevek:
Appropriate dosage to be individually determined; daily for 16 weeks
Más nevek:
Appropriate dosage to be individually determined; daily for 16 weeks
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
Időkeret: 16 weeks (end of Active Treatment phase), and follow-up
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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).
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16 weeks (end of Active Treatment phase), and follow-up
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Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
Időkeret: 16 weeks (end of Active Treatment phase), and follow-up
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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).
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16 weeks (end of Active Treatment phase), and follow-up
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Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
Időkeret: Week 16 (End of Active Treatment Phase) and Follow-Up
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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).
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Week 16 (End of Active Treatment Phase) and Follow-Up
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Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
Időkeret: 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).
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Week 16 (End of Active Treatment Phase) and Follow-Up
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Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
Időkeret: Week 16 (End of Active Treatment Phase) and Follow-Up
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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.
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Week 16 (End of Active Treatment Phase) and Follow-Up
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Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
Időkeret: Week 16 (End of Active Treatment Phase) and Follow-Up
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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.
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Week 16 (End of Active Treatment Phase) and Follow-Up
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest
Időkeret: Week 16, End of Active Treatment Phase
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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.
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Week 16, End of Active Treatment Phase
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Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)
Időkeret: Week 16 (End of Active Treatment Phase) and Follow-Up
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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).
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Week 16 (End of Active Treatment Phase) and Follow-Up
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Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency
Időkeret: Week 16 (End of Active Treatment Phase) and Follow-Up
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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.
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Week 16 (End of Active Treatment Phase) and Follow-Up
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Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency
Időkeret: Week 16 (End of Active Treatment Phase) and Follow-Up
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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.
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Week 16 (End of Active Treatment Phase) and Follow-Up
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Test of Silent Reading Fluency and Comprehension (TOSREC)
Időkeret: Week 16, End of Active Treatment Phase
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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.
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Week 16, End of Active Treatment Phase
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Együttműködők
Nyomozók
- Kutatásvezető: Carolyn A Denton, Ph.D., The University of Texas Health Science Center, Houston
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2010. november 1.
Elsődleges befejezés (Tényleges)
2015. június 1.
A tanulmány befejezése (Tényleges)
2015. június 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2010. május 26.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2010. május 28.
Első közzététel (Becslés)
2010. május 31.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2017. április 11.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2017. február 27.
Utolsó ellenőrzés
2017. február 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Mentális zavarok
- Idegrendszeri betegségek
- Neurológiai megnyilvánulások
- Neuroviselkedési megnyilvánulások
- Figyelemhiány és zavaró viselkedési zavarok
- Neurofejlődési zavarok
- Nyelvi zavarok
- Kommunikációs zavarok
- Tanulási nehézségek
- Figyelemhiányos zavar hiperaktivitással
- Diszlexia
- A gyógyszerek élettani hatásai
- Adrenerg szerek
- Neurotranszmitter szerek
- A farmakológiai hatás molekuláris mechanizmusai
- Vérnyomáscsökkentő szerek
- Autonóm ügynökök
- Perifériás idegrendszeri szerek
- Adrenerg alfa-2 receptor agonisták
- Adrenerg alfa-agonisták
- Adrenerg agonisták
- Neurotranszmitter felvétel gátlók
- Membrán transzport modulátorok
- Dopamin szerek
- Dopaminfelvétel gátlók
- Központi idegrendszeri stimulánsok
- Szimpatomimetikumok
- Adrenerg felvétel gátlók
- Metilfenidát
- Atomoxetin-hidroklorid
- Amfetamin
- Adderall
- Guanfacin
Egyéb vizsgálati azonosító számok
- HSC-MS-09-0531
- R01HD060617 (Az Egyesült Államok NIH támogatása/szerződése)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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