Interventions for Children With Attention and Reading Disorders

Browse trials for

• Dyslexia 124
• Attention Deficit Disorder with Hyperactivity 1,514

Dyslexia

124 studies on the registry are indexed under Dyslexia; 27 are open to participants now.

This study's enrollment of 222 is above the median of 76 across 106 interventional studies indexed under Dyslexia.

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Study arms

• Experimental
  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.

  Behavioral: Intensive reading instruction

• Experimental
  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.

  Drug: Methylphenidate · Behavioral: Parent Training · Drug: Mixed Salt Amphetamine · Drug: Atomoxetine · Drug: Guanfacine

• Experimental
  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.

  Drug: Methylphenidate · Behavioral: Intensive reading instruction · Behavioral: Parent Training · Drug: Mixed Salt Amphetamine · Drug: Atomoxetine · Drug: Guanfacine

Interventions

• DrugMethylphenidate

  Appropriate dosage to be individually determined; daily for 16 weeks

  Also known as: Concerta Extended Release, Ritalin

• BehavioralIntensive reading instruction

  Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.

• BehavioralParent Training

  Nine sessions on parenting a child with ADHD

• DrugMixed 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

  Also known as: Adderall Extended Release (XR)

• DrugAtomoxetine

  Appropriate dosage to be individually determined; daily for 16 weeks

  Also known as: Strattera

• DrugGuanfacine

  Appropriate dosage to be individually determined; daily for 16 weeks

  Also known as: Intuniv

Primary outcomes

1. Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention

   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).

   Time frame: 16 weeks (end of Active Treatment phase), and follow-up

2. Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity

   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).

   Time frame: 16 weeks (end of Active Treatment phase), and follow-up

3. Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention

   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).

   Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

4. Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity

   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).

   Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

5. Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest

   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.

   Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

6. Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest

   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.

   Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

Secondary outcomes

1. Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest

   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.

   Time frame: Week 16, End of Active Treatment Phase

2. Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)

   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).

   Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

3. Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency

   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.

   Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

4. Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency

   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.

   Time frame: Week 16 (End of Active Treatment Phase) and Follow-Up

5. Test of Silent Reading Fluency and Comprehension (TOSREC)

   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.

   Time frame: Week 16, End of Active Treatment Phase

Baseline characteristics

Publications

• Dvorsky M, Tamm L, Denton CA, Epstein JN, Schatschneider C. Trajectories of Response to Treatments in Children with ADHD and Word Reading Difficulties. Res Child Adolesc Psychopathol. 2021 Aug;49(8):1015-1030. doi: 10.1007/s10802-021-00815-y. Epub 2021 Mar 26. PubMed 33772416 ↗