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Interventions for Children With Attention and Reading Disorders (ICARD)

27. února 2017 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

222

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45206
        • Cincinnati Children's Hospital Medical Center
    • Texas
      • Houston, Texas, Spojené státy, 77030
        • University of Texas Health Science Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

7 let až 12 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. 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.
  2. Have at least 4 symptoms of inattention rated "Often" or "Very Often" on the teacher version of the SNAP-IV.
  3. 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
  4. Attend a participating school in Grades 2-5
  5. Have at least one parent or guardian who understands English well enough to participate in the behavioral parent training intervention.
  6. 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:

  1. Any documented or suspected bipolar disorder, severe psychosis, or other severe emotional disturbance, developmental disability, or autism.
  2. Receipt of primary school reading instruction in a language other than English.
  3. A history or presence of cardiovascular problems that would contraindicate stimulant treatment.
  4. Chronic vocal tics.
  5. 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: Intensive reading instruction
Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.
Experimentální: 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.
Lék: Methylphenidate
Appropriate dosage to be individually determined; daily for 16 weeks
Ostatní jména:
  • Ritalin
  • Concerta Extended Release
Behaviorální: Parent Training
Nine sessions on parenting a child with ADHD
Lék: Mixed Salt Amphetamine
Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta
Ostatní jména:
  • Adderall Extended Release (XR)
Lék: Atomoxetine
Appropriate dosage to be individually determined; daily for 16 weeks
Ostatní jména:
  • Strattera
Lék: Guanfacine
Appropriate dosage to be individually determined; daily for 16 weeks
Ostatní jména:
  • Intuniv
Experimentální: 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.
Behaviorální: Intensive reading instruction
Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.
Lék: Methylphenidate
Appropriate dosage to be individually determined; daily for 16 weeks
Ostatní jména:
  • Ritalin
  • Concerta Extended Release
Behaviorální: Parent Training
Nine sessions on parenting a child with ADHD
Lék: Mixed Salt Amphetamine
Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta
Ostatní jména:
  • Adderall Extended Release (XR)
Lék: Atomoxetine
Appropriate dosage to be individually determined; daily for 16 weeks
Ostatní jména:
  • Strattera
Lék: Guanfacine
Appropriate dosage to be individually determined; daily for 16 weeks
Ostatní jména:
  • Intuniv

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The University of Texas Health Science Center, Houston

Spolupracovníci

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital Medical Center, Cincinnati

Vyšetřovatelé

  • Vrchní vyšetřovatel: Carolyn A Denton, Ph.D., The University of Texas Health Science Center, Houston

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2010

Primární dokončení (Aktuální)

1. června 2015

Dokončení studie (Aktuální)

1. června 2015

Termíny zápisu do studia

První předloženo

26. května 2010

První předloženo, které splnilo kritéria kontroly kvality

28. května 2010

První zveřejněno (Odhad)

31. května 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. dubna 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. února 2017

Naposledy ověřeno

1. února 2017

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HSC-MS-09-0531
  • R01HD060617 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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