NCT01133847: ICARD

Reading ICARD: Interventions for Children With Attention and Reading Disorders

Completed Phase 4 Results posted Last updated 27 February 2017

What this trial tests

Phase 4 trial testing Methylphenidate in Attention Deficit Hyperactivity Disorder in 222 participants. Completed in 1 June 2015.

Timeline

1 November 2010

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	222
Start date	1 November 2010
Primary completion	1 June 2015
Estimated completion	1 June 2015
Sites	2 locations across United States

Drugs / interventions tested

• Methylphenidate (methylphenidate) — full drug profile →
• Intensive reading instruction
• Parent Training
• Mixed Salt Amphetamine — full drug profile →
• Atomoxetine (ATOMOXETINE) — full drug profile →
• Guanfacine (GUANFACINE) — full drug profile →

Conditions studied

• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
• Reading Disabilities — all drugs for Reading Disabilities →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 7 to 12, any sex, with Attention Deficit Hyperactivity Disorder or Reading Disabilities. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention
  Time frame: 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).
• Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity
  Time frame: 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).
• Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention
  Time frame: 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).
• Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity
  Time frame: 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).
• Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest
  Time frame: 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.
• Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest
  Time frame: 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.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Effects of ADHD Treatment and Reading Intervention on the Fluency and Comprehension of Children with ADHD and Word Reading Difficulties: A Randomized Clinical Trial.
   Denton CA, Tamm L, Schatschneider C, Epstein JN. · · 2020 · cited 9× · PMID 32982141 · DOI 10.1080/10888438.2019.1640704
2. Amphetamines in child medicine: a review of ClinicalTrials.gov.
   Alalalmeh SO, Hegazi OE, Shahwan M, Alshehri FS, et al · · 2023 · cited 1× · PMID 37854716 · DOI 10.3389/fphar.2023.1280562
3. Trajectories of Response to Treatments in Children with ADHD and Word Reading Difficulties.
   Dvorsky M, Tamm L, Denton CA, Epstein JN, et al · · 2021 · PMID 33772416 · DOI 10.1007/s10802-021-00815-y