Abstract
Convergence insufficiency (CI) is a vision disorder that affects approximately 5% of school-aged children and is associated with symptoms and impairments when reading or doing close work. (Borsting, Rouse, Deland, et al., 2003; Borsting, Rouse, Mitchell, et al., 2003; Letourneau & Ducic, 1988; Letourneau, Lapierre, & Lamont, 1979; Rouse et al., 1999; Rouse, Borsting, Mitchell, Cotter, et al., 2009; Rouse, Borsting, Mitchell, Kulp, et al., 2009). Children with CI self-report more somatic (e.g., eyes hurt and headaches), visual (e.g., blur and diplopia), and performance (e.g., loss of concentration, frequent need to re-read, and difficulty remembering what is read) problems compared with children with normal vision (Borsting, Rouse, Mitchell, et al., 2003; Rouse, Borsting, Mitchell, Cotter, et al., 2009). In addition, parents of children with CI have reported a significantly greater level of adverse academic behaviors and worry about school performance when compared with children with normal binocular vision (Rouse, Borsting, Mitchell, Kulp, et al., 2009). The specific adverse academic behaviors reported by parents include difficulty completing schoolwork, avoidance of reading and studying, and inattentiveness during reading.
Recent randomized clinical trials have found that office-based vergence accommodative therapy (OBVAT) is the most effective treatment for reducing somatic, visual, and performance based symptoms and improving clinical signs of CI in children when compared with sham and home-based treatments (Barnhardt et al., 2012; Convergence Insufficiency Treatment Trial [CITT] Study Group, 2008b; Scheiman, Mitchell, Cotter, Cooper, et al., 2005). In addition, improved and successful outcomes after treatment for symptomatic CI in school-aged children were associated with an overall reduction in the frequency of adverse academic behaviors and parental concern associated with reading and schoolwork (Borsting et al., 2012).
Parental report of adverse behaviors related to schoolwork in children with symptomatic CI could have potential implications for the diagnosis of disorders that rely on parent observations of children’s behaviors or emotional problems. For example, recent studies have suggested a possible relationship between CI and ADHD (Borsting, Rouse, & Chu, 2005; Granet, Gomi, Ventura, & Miller-Scholte, 2005; Gronlund, Aring, Landgren, & Hellstrom, 2007; Rouse, Borsting, Mitchell, Kulp, et al., 2009). Borsting et al. (2005) noted that a number of symptoms frequently reported by children with CI (e.g., loss of concentration when reading or reading slowly) and by parents are similar to behaviors that are commonly reported in the inattentive type of ADHD (e.g., failure to complete assignments and trouble concentrating in class; American Psychiatric Association, 1994; Conners, 1997). In addition, a previous study found that children with CI scored higher than a visually normal group on a parent-reported somatic scale (Borsting, Rouse, Deland, & Convergence Insufficiency and Reading Study Group, 1999). These studies have assessed a limited range of behavioral and emotional problems in children with CI. However, the positive results would indicate the need for further investigation of a broader range of behavioral and emotional problems in children with this specific vision anomaly.
As an initial step to address this issue, we conducted a two-part study. First, we assessed a broad range of behavioral and emotional problems in children with CI. Next, we determined whether the successful treatment of CI was associated with a change in adverse behaviors and emotional problems.
Method
This was a multicenter study conducted by the Convergence Insufficiency Treatment Trial–Reading Study (CITT-RS) Group at seven clinical sites (see the appendix). The study investigated parental report of behavioral and emotional factors, along with academic performance in children with CI in preparation for conducting a large multicenter clinical trial investigating possible impact of improving CI on academic, behavioral, and emotional factors in school-aged children. The results of the academic assessment will be reported in a separate paper. This open trial was designed to gather data that would help with determining appropriate assessment tools and typical participant responses needed for a future clinical trial. The respective institutional review boards approved the protocol and Health Insurance Portability and Accountability Act (HIPAA)-compliant informed consent forms. The parent or legal guardian of each participant gave written informed consent, and written assent was obtained from each child.
Participants
Children and adolescents ages 9 to 17 years with symptomatic CI were recruited at participating CITT clinical centers. All children were screened for cognitive ability with the Kaufman Brief Intelligence Test–II, with an inclusion criteria of IQ > 80 (Kaufman & Kaufman, 2004). Additional eligibility criteria were proficiency in English and an absence of substance abuse (parental report). Children with a history of developmental disability that would interfere with the ability to obtain valid test results (examiner discretion) were excluded. See Table 1 for a comprehensive list of inclusion and exclusion criteria.
Eligibility and Exclusion Criteria for Children With Convergence Insufficiency (CI).
The diagnosis of CI was made following a comprehensive eye examination. Children with visual acuity of 20/25 or worse, significant uncorrected refractive error, and significant ocular pathology were excluded. The diagnostic criteria for CI were an exodeviation at near at least 4 prism diopters greater than at far, a receded near point of convergence (NPC) break (6 cm or greater), insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard’s criterion [PFV less than twice the near phoria; Sheard, 1930] or minimum PFV of ≤15Δ base-out blur or break), and a Convergence Insufficiency Symptom Score (CISS) of 16 or higher (CITT Study Group, 2008a, 2008b; Scheiman, Cotter, Rouse, Mitchell, et al., 2005; Scheiman, Mitchell, Cotter, Kulp, et al., 2005). The CISS is a 15-item survey that quantifies the frequency and severity of somatic, visual, and performance based symptoms using a 5-point scale of never (0), infrequently or just a little (1), sometimes (2), fairly often (3), or always (4) (Table 2; Borsting, Rouse, Deland, et al., 2003; CITT Study Group, 2008a, 2008b; Rouse, Borsting, Mitchell, Cotter, et al., 2009; Scheiman, Cotter, Rouse, Mitchell, et al., 2005; Scheiman, Mitchell, Cotter, Kulp, et al., 2005). Scores on the CISS range from 0 to 60. Two measures of accommodation, Donder’s push-up and accommodative facility for the right eye, were also included in the evaluation because of the high association between CI and accommodative anomalies (Borsting, Rouse, Deland, et al., 2003; Rouse et al., 1999; Scheiman & Wick, 2002).
Convergence Insufficiency Symptom Survey (CISS).
Note. Numbers in each cell are the percentage of responses at the pre-treatment visit.
Procedures (Pre-Treatment: Comparison With Normal Scores)
Parental report of behavioral and emotional problems in children with CI was measured, prior to treatment, using the Conners 3 ADHD Index and the Child Behavior Checklist (CBCL). The Conners 3 ADHD Index and the CBCL were administered according to standard clinical administration procedures (Achenbach, 1991; Conners, 2009). The Conners 3 ADHD Index is a 10-item scale designed to identify children who are at increased risk of ADHD. A parent rates each behavior on a 4-point scale: not true at all (0), just a little true (1), pretty much true (2), and very much true (3).
The CBCL is a 120-item scale that assesses competencies, adaptive functioning, and behavioral, emotional, and social problems in children from 6 to 18 years of age. The respondents rate each behavior or symptom on a 3-point scale: not true (0), somewhat or sometimes true (1), or very true or often true (2). Results from the CBCL are divided into three competency scales (social, activities, and school), eight empirically based symptom or problem scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule breaking behavior, and aggressive behavior), and two global scores derived from the empirically based scales (internalizing and externalizing problems; Achenbach, 1991). The CBCL competency scales are scored such that lower scores indicate more problems whereas on the empirically based and global scales, higher scores indicate more problems.
Pre- to Post-Treatment
In the next part of the study, we determined whether changes in the behavioral and emotional problems occurred following treatment of CI. Children who completed the pre-treatment assessment were offered the option of enrolling in OBVAT for 16 weeks of treatment. This treatment involved weekly 60-min office visits that included specific therapy procedures to stimulate the vergence and accommodative systems. At each weekly visit, the patient performed four to five procedures with constant supervision and guidance from the therapist. There were no diagnostic tests performed during these sessions. The therapist followed a detailed and specific protocol from the CITT Manual of Procedures (accessed at http://optometry.osu.edu/research/CITT/4363.cfm); this document describes each procedure, amount of time used, expected performance, and criteria for ending the procedure and advancing to a more difficult level. At the end of each office visit, home reinforcement therapy was assigned for 15 min per day for 5 days a week and the child completed a home therapy log sheet to record how much therapy was completed.
After completing 16 weeks of OBVAT, children were prescribed a maintenance therapy program to be performed at home for 8 weeks before returning for a primary outcome visit at Week 24. This therapy consisted of one gross convergence technique and one vergence technique. We did not record the adherence to this phase of the home therapy treatment. A more detailed description of OBVAT and maintenance therapy has been published previously (CITT Study Group, 2008b).
At the end of maintenance therapy, the Conners 3 ADHD Index and the CBCL were completed by the parent of each child with CI. Enrollment windows were designed to insure that the child was attending school at the pre-treatment visit and had not been out of school for more than 2 weeks at the 24-week outcome visit.
Data Analysis
All analyses were performed using SAS Version 9.2 (Cary, North Carolina). To analyze the behavioral and emotional responses prior to treatment in children with CI, a Wilcoxon sign rank test (the non-parametric equivalent to a paired t test) was used to compare the mean of the Conners 3 ADHD Index and the scales of the CBCL to their published normative value. Raw scores for the Conners 3 ADHD Index and CBCL were converted to z-scores (Zi = (Xi – M)/SD for i = 1 to n with M and SD based on participant’s age and gender) to express the deviation from the normative group in standard deviation units according to procedures recommended in the manual (Achenbach, 1991; Conners, 2009). Our analysis with z-scores used the same formula as Cohen’s d for determining effect size and clinical significance (see below). In the text, we refer to this value as “d.” To analyze the impact of treatment on behavioral and emotional status in children with CI, the mean change from baseline to Week 24 was divided by the standard deviation of the measure at baseline to calculate the effect size. This calculation provides a Cohen’s d effect size value for changes observed after treatment. Wilcoxon sign rank analyses were performed comparing the mean improvement after treatment in each measure with zero to assess for statistical significance. A Bonferroni adjustment was made to account for the multiple statistical tests. As such, an alpha level of .0036 (.05 / 14) was used to assess statistical significance for the pre-treatment and the pre- to post-treatment results. Children who did not complete the post-treatment evaluation were excluded from these analyses.
To characterize the magnitude of the observed responses from pre- to post-treatment and their clinical significance, we used the Cohen’s d effect sizes (Cohen, 1988; Verkleij et al., 2011) The following classifications were used to quantify the observed effect sizes: small effect 0.2 ≤ d < 0.5, medium effect 0.5 ≤ d < 0.8, and large effect d ≥ 0.8.
For pre-treatment scales with a mean d score greater than one, a post hoc assessment of treatment effect was performed using only those children scoring 1.0 standard deviation above the mean. This allowed us to investigate changes in treatment in children who had the highest scores at baseline.
Results
Pre-Treatment Data: Comparison With Normal Scores
From January 2009 to February 2010, 53 symptomatic children with CI enrolled in the study and completed baseline testing. The mean age (SD) of the children with CI at baseline was 11.5 (2.27); 57% were female, 49% were White, 43% were African American, and 30% reported Hispanic or Latino ethnicity. At baseline, the mean (SD) clinical findings were exodeviation of 2.1Δ (2.7) at distance and 10.0Δ (4.3) at near; NPC break of 13.7 cm (8.0); and PFV break at near of 10.7Δ (3.9); and a CISS score of 28.9 (9.0). The frequency of individual item endorsement on the CISS is listed in Table 2. A parent-reported diagnosis of ADHD was reported for 8 (15%) children but only 2 were currently being treated with a stimulant.
Prior to treatment, the mean (SD) d score for the Conners 3 ADHD Index was 1.27 (1.81) and was significantly different from the population norms (p < .0001). The d scores ranged from −0.66 to 6.21 with 16 scoring at 1.5 standard deviation or higher. To investigate the individual responses on the Conners 3 ADHD Index, we divided the index into inattentive items (six items) and hyperactive/impulsive items (four items) based on classification described in the manual (Conners, 2009). We assigned numerical values 0 (not true at all), 1 (just a little true), 2 (pretty much true), and 3 (very much true) to the response scale and compared the mean response with the inattentive and hyperactive/impulsive items for the Conners 3 ADHD Index. The item mean for the six inattention items was 1.17 (SD = 0.77), and the item mean for the hyperactive items was 0.74 (SD = 0.66). Compared with hyperactive items, inattention items were endorsed with significantly greater severity using a Wilcoxon sign rank test (p < .0001).
The mean (SD) effect sizes for the CBCL at baseline are shown in Table 3. Each score was compared with published normative values where 0 would indicate no difference from the normative population mean. For the competence scales (social, activities, and school), only the school competence scale approached significance and had a medium effect size. Children with symptomatic CI scored significantly higher on the somatic complaints scale with a large effect size (d = 1.36). The aggressive behavior scale and externalizing problems scale were significantly lower than mean values with small effect sizes (d = −0.37 and d = −0.36, respectively). The internalizing problems scale was elevated but did not reach statistical significance.
Descriptive Statistics for t Scores and Effect Size (d Score) Based on the Mean and Standard Deviation From the Normal Sample for Each Subscale Scores of the Child Behavior Checklist at the Pre-Treatment Examination.
Comparing mean with zero using a Wilcoxon sign rank test.
Alpha level of .0036 (.05 / 14) based on Bonferroni adjustment.
Pre- to Post-Changes With Treatment
Of the 53 symptomatic children with CI, 48 consented to OBVAT with 45 completing 16 weeks of OBVAT and 44 returning for the 24-week primary outcome examination (8 weeks after completing OBVAT). The mean age of those completing OBVAT was 11.4 years (range = 9-16 years) and 52% were female. Half of the participants reported their race as White/Caucasian with another 41% reporting African American. Twenty-seven percent of the children were of Hispanic or Latino ethnicity. Parents reported that 5 (11%) of the children had been diagnosed with ADHD but only 1 was currently being treated with a stimulant.
Symptoms and clinical signs of CI improved significantly following treatment (p < .0001 for all measures; Table 4). A significant improvement after treatment was found for the Conners 3 ADHD Index with a medium effect size (d = 0.58) that was significantly different from 0 (p < .0001). The changes with treatment for the CBCL subscales are listed in Table 5. On the CBCL competency scales, school activities nominally improved but did not reach statistical significant after adjusting for multiple tests. Children improved significantly on the anxious/depressed, somatic complaints, and internalizing problems scales. For the anxious/depressed scale, the effect size for improvement was small (d = 0.36). A medium effect size was seen for the internalizing problems scale (d = 0.67), and a large effect size was seen for the somatic complaints scale (d = 1.15).
The Pre- to Post-Treatment Values for the Clinical Signs and Symptoms of CI for Those Who Completed the Treatment and the 24-Week Outcome Visit.
Note. CI = convergence insufficiency; CISS = Convergence Insufficiency Symptom Survey; NPC = near point of convergence; PFV = positive fusional vergence.
Descriptive Statistics for Effect Size of Pre- to Post-Treatment Changes (Week 24 Minus Baseline Divided by Standard Deviation at Baseline) in Each CBCL Subscale.
Comparing mean to zero using a Wilcoxon sign rank test.
Alpha level of .0036 (.05 / 14) based on Bonferroni adjustment.
Additional analyses were performed investigating the effect of treatment of children who scored greater than 1 standard deviation above the mean at the pre-treatment examination. These analyses were limited to the Conners 3 ADHD Index and CBCL somatic complaints scale. Twenty-three children had a Conners 3 ADHD Index score greater than 1 standard deviation above the mean at pre-treatment, and this group experienced a large effect size after treatment (d = 1.47). For the CBCL somatic complaints scale, 25 children scored 1 standard deviation above the mean and also showed a large effect size following treatment (d = 1.89).
Discussion
To our knowledge, this is the first study that assessed a broad range of behavioral and emotional problems in children with symptomatic CI. Before treatment, these children manifest significantly more ADHD-like behaviors than the published norms, as measured by the Conners 3 ADHD Index. On the CBCL, children with symptomatic CI scored significantly higher on the somatic complaints scale. Following treatment for CI, the scores on the Conners 3 ADHD Index and the CBCL internalizing problem scales improved significantly, while the CBCL externalizing problems remained unchanged.
Strengths of the study included an assessment of emotional and behavioral problems in a well-defined sample of children with CI and investigation of the effects of treatment on the Conners 3 ADHD Index and CBCL. Limitations of the study include unmasked examinations, using only parental report for evaluating behaviors and emotional problems, and a lack of a sham treatment group to control for possible placebo effects derived from the treatment ritual (e.g., coming to a clinic for treatment and therapist–child interactions).
The higher frequency of ADHD-like behaviors on the Conners 3 ADHD Index found in children with symptomatic CI could be related to a sampling bias. That is, symptomatic children with CI and ADHD-like symptoms might be more likely to pursue eye care than symptomatic CI children without ADHD-like symptoms. In addition, we only relied on parental report and did not get reports from the child’s teacher who maybe a better judge of ADHD symptoms. We cannot rule out sampling bias at this time.
We found concurrent improvement in the clinical signs and symptoms associated with CI and the Conners 3 ADHD index scores following treatment. The changes in the Conners 3 ADHD index scores were the highest in children scoring at 1.0 standard deviation above the mean at baseline. This group showed an effect size of 1.47 following treatment. This pattern of results agrees with previous studies that indicated that symptoms and behaviors related to CI may be similar to some ADHD behaviors and improve with treatment (Barnhardt et al., 2012; Borsting et al., 2012; Borsting et al., 2005; CITT Study Group, 2008b; Rouse, Borsting, Mitchell, Kulp, et al., 2009). The effect size change observed in the children who scored high at baseline was significant and larger than typical placebo effects. However, without conducting a randomized masked trial using ADHD scales, we cannot conclude that treating symptomatic CI would result in a long-lasting reduction in ADHD behaviors.
On the CBCL at baseline, the largest difference from normative values was observed for the somatic category. This was largely affected by the questions about eye problems (67% responded somewhat true or very true) and headaches (59% responded somewhat true or very true). The response of eye problem would be expected from those with symptomatic CI’s and headache is a common patient complaint in children with CI (Borsting, Rouse, Mitchell, et al., 2003). In fact, 57% of the CI children reported headaches sometimes, fairly often, or always when reading and doing close work on the CISS (Table 2). The somatic index on the CBCL also showed the largest effect size following treatment with children scoring high at baseline showing the largest improvements. This is consistent with the improvement in child-reported symptoms on the CISS (Table 4).
The combination of somatic symptoms, particularly headaches and eye problems, and parental concern about academic and inattention could indicate an increased risk of the child having a CI. Because CI is often missed on a school-based vision screening, a referral to an eye care professional may be indicated in such cases. Although we still need further studies to determine whether successful treatment of CI will result in concurrent improvement in attention, we do have sufficient evidence that successful treatment of CI does result in fewer somatic, perceptual, and performance symptoms as reported by the child. Two recent multicenter clinical trials comparing various treatments for school-aged children with CI demonstrated a significant reduction in symptoms related to near work and improvements in clinical signs following successful treatment of CI (CITT Study Group, 2008b; Scheiman, Mitchell, Cotter, Cooper, et al., 2005). From an eye care perspective, the reduction in vision-related symptoms and improvement in clinical signs of CI are the primary reasons for treatment. In addition, a recent study indicated that successful treatment of CI resulted in a lower frequency of adverse academic behaviors as reported by the parent. The results of this study indicate that further investigation of the possible effects of CI treatment on ADHD-like behaviors and other psychopathology is warranted. Our initial hypothesis is that the CI adversely affects attention and this may lead to problem behaviors noticed by parents.
In summary, parents of children with symptomatic CI report a higher frequency of ADHD-like behaviors as measured by the Conners 3 ADHD Index and more somatic problems. In an open trial, attention and internalizing problems improved following treatment with OBVAT. Further investigation into the impact of CI treatment on attention and internalizing problems is warranted.
Footnotes
Appendix
The CITT- RS Group includes the authors and the investigators listed below. Sites are listed in order of number of patients enrolled in the study (shown in parenthesis after site name and location). Personnel are listed as PI for principal investigator, E for examinor, SC for study coordinator, and VT for vision therapist
Authors’ Note
Portions of the study were presented as a poster at the Association of Research in Vision and Ophthalmology in April of 2011 and at the American Academy of Optometry in October of 2010 and 2011.
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Arnold has received research funding and/or advisory board honoraria from Astra-Zeneca, Biomarin, CureMark, Lilly, Novartis, Noven, Roche, Seaside Therapeutics, and Shire, consulting honorarium from Tris Pharma, and travel support from Noven.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded in part by a grant from the College of Optometrist in Vision Development and the Ohio State University College of Optometry Clinical Center.
