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NCT01133847 · ClinicalTrials.gov registry record · Phase 4

Interventions for Children With Attention and Reading Disorders

A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.

Completed
Registry status
Phase 4
Development phase
222
Enrollment target

NCT01133847: Completed Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.

NCT01133847 is a Phase 4 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 222 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01133847, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center, Houston.

COMPLETED
Registry status
Phase 4
Development phase
222 participants
Enrollment target

Study Summary

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.

Primary Outcome

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).

Interventions

  • DRUG Methylphenidate
  • DRUG Atomoxetine
  • BEHAVIORAL Parent Training
  • BEHAVIORAL Intensive reading instruction
  • DRUG Mixed Salt Amphetamine

Trial Details

FieldValue
Enrollment Target 222 participants
Start Date 2010-11
Est. Completion 2015-06
Phase Phase 4

What the finished NCT01133847 record still lists

NCT01133847 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 5 interventions - of which Methylphenidate is the first listed.

NCT01133847 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01133847 about?

NCT01133847 is a clinical study titled "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 outcome...

What is the current status of trial NCT01133847?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 222 participants. The study started on 2010-11. Estimated completion is 2015-06.

What interventions are being tested in trial NCT01133847?

The interventions under investigation include: Methylphenidate (DRUG), Atomoxetine (DRUG), Parent Training (BEHAVIORAL), Intensive reading instruction (BEHAVIORAL), Mixed Salt Amphetamine (DRUG).

Who is sponsoring clinical trial NCT01133847?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01133847's enrollment target sits among peer trials

222 383rd of 2000 higher than 1,618 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01133847, the US trial registry maintained by the National Library of Medicine. NCT01133847 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.