in progress

Final Research Plan

Autism Spectrum Disorder in Young Children: Screening

June 10, 2021

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 autism spectrum disorder (ASD) in children ages 12 to 36 months improve:
    1. Access and timing of ASD evaluation, diagnosis, and intervention?
    2. Developmental, functional, and quality of life outcomes?
  2. What is the accuracy of screening instruments to detect ASD in children ages 12 to 36 months?
  3. What are the harms of screening for ASD in children ages 12 to 36 months and their families?
  4. Do interventions targeting young children with ASD improve developmental, functional, and quality of life outcomes?
    1. To what extent is the timing of intervention initiation (by age and in relation to the establishment of an ASD diagnosis) associated with ASD-related outcomes?
  5. What are the harms of interventions for ASD in young children?

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

  1. What inequities exist related to identifying and treating young children with ASD?
  2. What programs and support systems help facilitate earlier access to ASD-related services (evaluation or intervention) for children who have screened positive for or have otherwise been identified at risk for ASD?
  3. What is the relationship between access and timing of evaluation, diagnosis, and intervention and health outcomes (i.e., child developmental, functional, and quality of life and family/caregiver outcomes)?

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 Report. Criteria are overarching as well as specific to each of the key questions (KQs).

  Include Exclude
Population KQs 1–3: Children ages 12 to 36 months

KQs 4, 5: Children who screened positive for or were diagnosed with ASD who began an intervention at younger than age 6 years (<72 months)
KQs 1–3: Studies limited to infants younger than age 12 months

Studies limited to children with known language or communication delays, with known familial history of ASD, and for whom concerns of ASD have been raised by their parents or a clinician

KQs 4–5: Studies limited to interventions initiated among older children (age 6 years or older), adolescents, or adults

Studies limited to children with autism and another neurodevelopmental disorder or condition, sleep disorder, feeding problem, or medical or genetic condition
Setting KQs 1–3: Primary care settings and primary care–referable settings, childcare, and other educational settings

KQs 4, 5: Clinical, educational, early intervention, or home settings
Screening KQs 1, 3: Screening among unselected samples of children

KQ 2: Screening instruments designed specifically to detect ASD or general developmental screening instruments
KQs 1, 3: Screening of preselected (including prospectively followed) or referred populations

KQ 2: Genetic or biomarker screening or imaging
Interventions Behavioral and communication interventions, including developmental approaches, naturalistic developmental behavioral interventions, augmentative and alternative communication therapy, occupational therapy, speech therapy, parent training, and social skills training with or without other interventions. Interventions limited to:
  • Dietary approaches
  • Medication
  • Complementary and alternative medicine
Comparators KQs 1, 3: No screening or usual care

KQ 2: Diagnosis of ASD through clinical assessment or medical record review

KQs 4, 5: No intervention/waitlist, usual care, standard treatment, or minimal intervention
KQs 4, 5: Active ASD intervention (i.e., a study comparing two or more active ASD interventions without a true control group)
Outcomes KQ 1a: Timing of and age at referral, evaluation, diagnosis, and access to intervention

KQs 1b, 4: Developmental and functional outcomes including autism symptom severity; adaptive behavior; cognitive ability and intelligence; communication and language skills; social competence; daily living skills; problem behavior; academic placement/achievement; child quality of life or subjective well-being; caregiver stress, quality of life, or well-being

KQ 2: Raw cell values (true positive, true negative, false positive, false negative), sensitivity, specificity, positive and negative predictive values

KQ 3: Harms of ASD screening (e.g., stigma, family distress, false reassurance, opportunity cost)

KQ 5: Harms of intervention (e.g., deterioration or worsening in adaptive behavior or autism symptom severity, caregiver distress, diminished child quality of life, adverse psychological symptoms)

Outcomes will be grouped into the following time points: immediately postintervention, 1 to 5 months postintervention, 6 to 11 months, postintervention, 12 to 23 months, postintervention, 24 to 35 months, postintervention, and longer term

Study design KQs 1, 3–5: Randomized clinical trials; nonrandomized and quasiexperimental designs; retrospective and prospective cohort designs

KQ 2: Cross-sectional study; retrospective and prospective cohort designs
KQs 1, 3–5: Case-control studies; single case reports or single case design

KQ 2: Case-control studies, single case design
Study geography Studies that primarily take place in countries categorized as “Very High” on the 2019 Human Development Index (as defined by the United Nations Development Programme) Studies that primarily take place in countries not categorized as “Very High” on the 2019 Human Development Index
Publication language English Any language other than English
Publication date 2000 to present  
Publication type Peer-reviewed article or report Dissertation, thesis, or editorial/commentary
Quality rating Fair- or good-quality studies Poor-quality studies

A draft Research Plan was posted on the USPSTF website for public comment from February 25 to March 24, 2021. In response to public comment, the USPSTF clarified that for KQs 1 and 3, studies that evaluated any autism screening program (including those paired with developmental screening and surveillance) would be included and that studies limited to children with known risk factors for autism or for whom concerns had been raised would be excluded. While children at risk for autism may be especially important to screen, the USPSTF is interested in the benefits and harms of screening among unselected children. The USPSTF also added age of diagnosis as an outcome for KQ 1a. For KQ 2, the USPSTF clarified that studies that use medical records to identify diagnoses of autism would be included. For KQs 4 and 5, studies that evaluate interventions among children who screened positive for autism as well as those with an autism diagnosis will be included. Additionally, the term “ASD-specific” was removed from the description of included interventions for KQs 4 and 5. Studies of appropriate interventions among children who screened positive for autism or who were diagnosed with autism will be included, provided the study meets all other inclusion criteria. In addition, studies of occupational and speech therapy will be included if they are specifically targeted at children meeting the population inclusion criteria. Finally, the USPSTF clarified that studies limited to children with autism and another neurodevelopmental, medical, or genetic condition would be excluded. The USPSTF also made other minor clarifying changes.