in progress

Final Research Plan

Speech and Language Delay or Disorders in Children Age 5 Years or Younger: Screening

June 09, 2022

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

  1. Does screening for speech and language delay or disorders in children age 5 years or younger improve speech and language outcomes, school performance, function, or quality-of-life outcomes?
  2. What is the accuracy of screening tools to detect speech and language delay or disorders in children age 5 years or younger?
  3. What are the harms of screening for speech and language delay or disorders in children age 5 years or younger?
  4. Do interventions for speech and language delay or disorders in children age 6 years or younger improve speech and language outcomes?
  5. Do interventions for speech and language delay or disorders in children age 6 years or younger improve school performance, function, or quality-of-life outcomes?
  6. What are the harms of interventions for speech and language delay or disorders?

Contextual Questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. Are there disparities in the prevalence of speech and language delay or disorders among specific populations of children? If so, what factors contribute to these disparities?
  2. Are there disparities in the detection of speech and language delay or disorders in clinical practice and referral for diagnostic evaluation among specific populations of children? If so, what factors contribute to these disparities?
  3. Are there disparities in the provision and utilization of treatment for speech and language delay or disorders among specific populations of children? If so, what factors contribute to these disparities?

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the Key Questions.

Category  Include Exclude
Population KQs 1–3: Unselected or explicitly asymptomatic children age 5 years or younger who communicate using any language

KQs 4-6: Children who were diagnosed with a speech and language delay or disorder at age 6 years or younger*

All KQs: A priori specific populations of interest include those defined by age, sex, cultural/linguistic background, and native language
Studies limited to children who were preterm infants (<36 weeks of gestation) or with known conditions associated with speech and language delay or disorders, such as selective mutism, hearing impairment, developmental disorders (e.g., Down syndrome, fragile X syndrome, and autism), craniofacial anomalies, or neurological/neurogenetic disorders
Setting KQs 1–3: Primary care settings and primary care–referable settings, childcare, schools, and other education settings

KQs 4–6: Clinical, educational, early intervention, and home settings
All other settings
Screening All validated tools and procedures applicable for use in primary care–relevant settings, designed to identify a speech and/or language delay or impairment, that meets the following criteria:
  • ≤10 minutes to administer or to be interpreted in a primary care setting
  • >10 minutes if completed by a parent or teacher and interpreted by the clinician
Tools specifically for speech and/or language or general developmental instruments with a separate component for speech and/or language skills are eligible
Instruments not designed for use in children age 5 years or younger, or tools that take >10 minutes to administer or that are not feasible to administer in primary care settings

General developmental screening instruments that do not include a separate component for speech and language skills
Treatment/  Interventions Any interventions designed to improve speech and/or language in children delivered at any age, as long as diagnosis occurs when child is age 6 years or younger; interventions may be delivered in various formats (e.g., individual or group settings, face-to-face, or via telehealth); therapists may be speech-language pathologists or other clinicians, parents, or teachers Interventions delivered to children diagnosed after age 6 years
Comparisons KQs 1, 3: Screened vs. unscreened populations

KQs 2, 3: Screening tools vs. reference standard (diagnostic evaluation by qualified clinical professional)

KQ 4-6: Intervention vs. no intervention (or usual care)

KQs 1, 3: No comparator

KQ 2: Another screening tool

KQs 4–6: No comparator, studies comparing two active interventions (i.e., comparative effectiveness)
Outcomes KQs 1, 4: Speech and language outcomes, including speech domains (e.g., stuttering, fluency, and articulation) and language domains (e.g., expressive language, receptive language, phonology, vocabulary, syntax, and pragmatics)

KQ 1, 5: Measures of academic skills or achievement (e.g., reading comprehension), behavior competence, socioemotional functioning, and quality of life

KQ 2: Measures of screening test accuracy (e.g., sensitivity, specificity, positive and negative predictive value, likelihood ratios, and area under the curve)

KQ 3: Harms of screening, including labeling, stigma, parent anxiety, and other psychosocial harms

KQ 6: Harms of interventions, including overdiagnosis, labeling, stigma, and others
All other outcomes
Study Designs KQs 1, 3, 6: Controlled cohort studies, RCTs, and nonrandomized, controlled trials

KQs 2: Cross-sectional or cohort studies

KQ 4, 5: RCTs

Case-control studies, case reports, case series, or systematic reviews
Country Studies conducted in countries categorized as “Very High” on the Human Development Index, as defined by the United Nations Development Programme Studies conducted in countries not categorized as “Very High” on the Human Development Index
Quality Rating Studies rated fair or good quality Studies rated poor quality
Language of published study English Non-English

* Age criteria for studies of treatment includes children as old as age 6 years given that children who would be screened at age 5 years and referred for treatment may not receive services immediately.

Abbreviations: KQ=key question; RCT=randomized, controlled trial.

The draft Research Plan was posted on the USPSTF website for public comment from January 20, 2022, to February 16, 2022. Several comments focused on the population inclusion and exclusion criteria. In response, the USPSTF added that children who communicate using any language at home are eligible, not just spoken language, and that studies enrolling unselected or asymptomatic populations are eligible. Studies enrolling an unselected population may include children with conditions listed as excluded who have not yet been diagnosed. Finally, several comments asked whether screening questionnaires and interventions limited to speech or language problems only (vs. both) are eligible. The USPSTF added minor edits to make clear that screening and treatment for speech disorders, language disorders, or both are included.