An early intervention program is coordinated multi-disciplinary care that involves combinations of traditional therapies such as physical, occupational and/or speech therapy, psychological counseling for families, nursing care, and physical or social stimulation for children from infancy to 3 years of age who have developmental delays or have a high potential for developmental delay. The duration of therapy may last for months or years depending on the deficits of the child and the needs of the family. Clear documentation of the efficacy of these treatment programs remains to be determined.

According to the Education of the Handicapped Act Amendments, federal legislation requires that each child recognized as having a disability that interferes with learning from infancy to age 3 have a written plan of service, an IFSP, (Individual Family Service Plan). An IFSP includes specific early intervention services that the family and child will receive and a projection of their duration. The law requires each state to create its own definition of developmental delay as a basis for determining eligibility of services. Services are provided not only for children with developmental delays, but also for those with biological conditions that may predispose to a delay. Additionally, states may provide services to children who may be at risk of developing developmental delays attributable to environmental factors. All states have established early intervention programs for children from birth to 3 years.

Rodgers and Paxton (2014) noted that depressive and eating disorder symptoms are highly co-morbid. To date, however, little is known regarding the efficacy of existing programs in decreasing concurrent eating disorder and depressive symptoms. These investigators conducted a systematic review of selective and indicated controlled prevention and early intervention programs that assessed both eating disorder and depressive symptoms. They identified a total of 26 studies. The large majority of identified interventions (92 %) were successful in decreasing eating disorder symptoms. However fewer than half (42 %) were successful in decreasing both eating disorder and depressive symptoms. Intervention and participant characteristics did not predict success in decreasing depressive symptoms. The authors concluded that indicated prevention and early intervention programs targeting eating disorder symptoms are limited in their success in decreasing concurrent depressive symptoms. They stated that further efforts to develop more efficient interventions that are successful in decreasing both eating disorder and depressive symptoms are needed.

Yavuz et al (2015) stated that obesity is a growing problem even in very young childhood, resulting in high costs for individuals and society. As a response, numerous obesity prevention and intervention programs have been developed. Previous research has shown that early intervention programs are more effective when parents are involved, but the effectiveness of specific aspects of programs with parental involvement has not been investigated. This meta-analysis examined the features related to the effectiveness of different types of obesity intervention programs involving parents and targeting young children (0 to 6 years of age). The Web of Science, PubMed, PsycInfo, CINAHL, and ERIC databases were searched for childhood obesity prevention and intervention programs involving parents. Data were analyzed using the Comprehensive Meta-analysis (CMA) software. A total of 50 studies with effect sizes measured at short-term follow-up (within 3 months from the end of the intervention) and 26 studies with effect sizes measured at long-term follow-up (all reported in a total of 49 publications) were identified. The combined effect size of interventions was small but significant at short-term follow-up (d = 0.08, p < 0.01). The results suggested the presence of a potential publication bias in studies providing results at long-term follow-up, with a non-significant adjusted effect size (d = 0.02), which indicated that obesity interventions were not effective at long-term follow-up. Multi-variate meta-regression analyses showed that interventions were more effective when including either interactive sessions or educational materials as opposed to those including both interactive sessions and non-interactive educational materials. No other moderators regarding sample characteristics, study design, or methodological quality were significant. The authors concluded that interventions targeting young children that require parental involvement are effective at short-term follow-up, specifically when interventions include 1 mode of intervention rather than 2; however, results were not retained in the long run.

Sourander et al (2016) examined if an Internet-assisted intervention using whole-population screening that targets the most symptomatic 4-year old children is effective at 6 and 12 months after the start of treatment. This 2-parallel-group randomized clinical trial was performed from October 1, 2011, through November 30, 2013, at a primary health care clinic in Southwest Finland. Data analysis was performed from August 6, 2015, to December 11, 2015. Of a screened population of 4,656 children, 730 met the screening criteria indicating a high level of disruptive behavioral problems. A total of 464 parents of 4-year old children were randomized into the Strongest Families Smart Website (SFSW) intervention group (n = 232) or an education control (EC) group (n = 232). The SFSW intervention, an 11-session Internet-assisted parent training program that included weekly telephone coaching. Main outcome measures included Child Behavior Checklist version for preschool children (CBCL/1.5-5) externalizing scale (primary outcome), other CBCL/1.5-5 scales and subscores, Parenting Scale, Inventory of Callous-Unemotional Traits, and the 21-item Depression, Anxiety, and Stress Scale. All data were analyzed by intention-to-treat and per protocol. The assessments were made before randomization and 6 and 12 months after randomization. Of the children randomized, 287 (61.9 %) were male and 79 (17.1 %) lived in other than a family with 2 biological parents. At 12-month follow-up, improvement in the SFSW intervention group was significantly greater compared with the control group on the following measures: CBCL/1.5-5 externalizing scale (effect size, 0.34; p < 0.001), internalizing scale (effect size, 0.35; p < 0.001), and total scores (effect size, 0.37; p < 0.001); 5 of 7 syndrome scales, including aggression (effect size, 0.36; p < 0.001), sleep (effect size, 0.24; p = 0.002), withdrawal (effect size, 0.25; p = 0.005), anxiety (effect size, 0.26; p = 0.003), and emotional problems (effect size, 0.31; p = 0.001); Inventory of Callous-Unemotional Traits callousness scores (effect size, 0.19; p = 0.03); and self-reported parenting skills (effect size, 0.53; p < 0.001). The authors concluded that the findings of this study revealed the effectiveness and feasibility of an Internet-assisted parent training intervention offered for parents of pre-school children with disruptive behavioral problems screened from the whole population. They stated that the strategy of population-based screening of children at an early age to offering parent training using digital technology and telephone coaching is a promising public health strategy for providing early intervention for a variety of child mental health problems.

Children with Autism Spectrum Disorders

Freitag et al (2012) noted that different early intervention programs, developed predominantly in the United States, for pre-school aged children with ASD have been published. Several systematic review articles including a German Health Technology Assessment on behavioral and skill-based early interventions in children with ASD reported insufficient evidence and a substantial problem of generalisability to the German context. In Germany, approximately 2 to 5 hrs early intervention is supported by social services. Here, these investigators reported the results of a 1 year pre-post pilot study on a developmentally based social pragmatic approach, the Frankfurt Early Intervention program (FFIP). In FFIP, individual 2:1, behaviorally and developmentally based therapy with the child is combined with parent training and training of kindergarten teachers. Treatment frequency is 2 hrs/week. Outcome measures were the VABS II, mental age and the ADOS severity score. Improvements after 1 year were observed for the VABS II socialization scale and the mental age quotient/IQ (medium effect sizes). Results were comparable with several other studies with a similar or slightly higher therapeutic intensity implementing comparable or different early intervention methods or programs. The authors concluded that compared to most high-intensity programs (30 to 40 hrs/week), lower cognitive gains were observed. They stated that results have to be replicated and assessed by a randomized controlled study before any final conclusions can be drawn.

Eapen et al (2013) evaluated the effectiveness of the Early Start Denver Model (ESDM) for preschool-aged children with ASD using a predominantly group-based intervention in a community child care setting. Participants were 26 children (21 males) with ASD with a mean age of 49.6 months. The ESDM, a comprehensive early intervention program that integrates applied behavior analysis with developmental and relationship-based approaches, was delivered by trained therapists during the child's attendance at a child care center for preschool-aged children with ASD. Children received 15 to 20 hours of group-based, and 1 hour of 1-to-1, ESDM intervention per week. The average intervention period was 10 months. Outcome measures were administered pre- and post-intervention, and comprised a developmental assessment

the Mullen Scales of Early Learning (MSEL) and two parent-report questionnaires

the Social Communication Questionnaire (SCQ), and Vineland Adaptive Behaviors Scales, Second Edition (VABS-II). Statistically significant post-intervention improvements were found in children's performance on the visual reception, receptive language and expressive language domains of the MSEL in addition to their overall intellectual functioning, as assessed by standardized developmental quotients. Parents reported significant increases in their child's receptive communication and motor skills on the VABS-II, and a significant decrease in autism-specific features on the SCQ. These effects were of around medium size, and appeared to be in excess of what may have been expected due to maturation. Nonetheless, these results need to be confirmed in a controlled study. The authors concluded that the findings of this study suggested community dissemination of ESDM using predominantly group-based intervention may be an effective intervention. Making ESDM accessible to the wider ASD community in child care settings has the potential for significant clinical and economic benefits. Moreover, they stated that further studies are indicated in this area, including those with younger children, and which incorporate a control group and standardized ASD assessments.

Tonge et al (2014) reviewed recent evidence and other earlier relevant articles regarding early intervention studies for children with ASD. There is a well-established body of empirical evidence for the effectiveness of Early Intensive Behavioral Intervention (EIBI) with young children with ASD. The importance of parent skills training, education and positive behavior support is also a key factor in influencing outcomes. Drug treatment is of short-term benefit for disruptive behavior but long-term outcome and metabolic side-effects have not been studied. The authors concluded that few studies have measured the long-term value and effectiveness of early intervention treatments, and currently there are no articles published on effects into adulthood of such treatments. Such research would indicate whether early intervention results in reduced reliance on health services into adulthood.

Caron and colleagues (2017) noted that for young children with ASD, one of the choice interventions is Early Intensive Behavioral Intervention (EIBI). Over the past 10 years, its effectiveness has been abundantly evaluated based on various parameters, including the intensity and duration of the intervention. Despite major advances in effectiveness evaluation, data concerning the implementation of the intervention are often described briefly, and the active ingredients of the intervention are but rarely linked to the documented effects. This study aimed at reviewing with a systematic method, the studies pertaining to EIBI provided to children with ASD over the past 10 years (2005 to 2015) and at documenting the program implementation components described in the studies, based on Dane and Schneider's (1998) model in accordance with PRISMA guidelines. The results showed that, although the variables related to intervention dosage and protocol were relatively well-described, the authors did not always consider them in the effects analysis. Furthermore, the majority of the studies did not report information on intervention participation, differentiation or quality. The authors concluded that data concerning the implementation of the intervention were partially described in the articles retained. In this regard, a better description of the intervention provided and a more systematic evaluation of its implementation appeared necessary to detect the subtle differences in the effects of the intervention.

Studer and associates (2017) stated that there is a major gap between the US and most European countries regarding the implementation of EIBI for children with autism. These investigators reported on the current status of EIBI in Switzerland and on the effectiveness of EIBI under clinical conditions in a Swiss pilot project. This study combined a narrative report of the care system for children with autism in Switzerland and an initial evaluation of EIBI as implemented in the Department of Child and Adolescent Psychiatry, University of Zurich. The current situation of the implementation of EIBI for children with autism in Switzerland is characterized by marked deficits in its acceptance. Major reasons include insufficient governmental approval and lacking legal and financial support. In addition, ignorance among health care providers and educational professionals has contributed to this situation precluding that children with autism receive the most beneficial assistance. The authors had initiated and been working in an intervention center offering EIBI for 10 years and reported on their experience with the implementation of EIBI. Based on their clinical practice, they documented that EIBI also works efficiently under ordinary mental health service conditions. The authors concluded that EIBI needs to be implemented more intensively in Switzerland. Moreover, they stated that although the effects of EIBI as implemented in Zurich are promising, the results are not as pronounced as under controlled research conditions.

School-Age Outcomes of Early Intervention for Preterm Infants and Their Parents

In a randomized controlled trial (RCT), Spittle and colleagues (2016) examined the child and parental outcomes at school age of a home-based early preventative care program for infants born very preterm and their caregivers. At term-equivalent age, 120 infants born at a gestational age of less than 30 weeks were randomly allocated to intervention (n = 61) or standard care (n = 59) groups. The intervention included 9 home visits over the first year of life focusing on infant development, parental mental health, and the parent-infant relationship. At 8 years corrected age, children's cognitive, behavioral, and motor functioning and parental mental health were assessed. Analysis was by intention-to-treat. A total of 100 children, including 13 sets of twins, attended follow-up (85 % follow-up of survivors). Children in the intervention group were less likely to have mathematics difficulties (odds ratio [OR], 0.42; 95 % confidence interval [CI]: 0.18 to 0.98; p = 0.045) than children in the standard care group, but there was no evidence of an effect on other developmental outcomes. Parents in the intervention group reported fewer symptoms of depression (mean difference [MD], -2.7; 95 % CI: -4.0 to -1.4; p < 0.001) and had reduced odds for mild-t- severe depression (OR, 0.14; 95 % CI: 0.03 to 0.68; p = 0.0152) than parents in the standard care group. The authors concluded that an early preventive care program for very preterm infants and their parents had minimal long-term effects on child neurodevelopmental outcomes at the 8-year follow-up, whereas primary caregivers in the intervention group reported less depression.

Early Ontervention for Critically Ill Adults in the Intensive Care Unit

Doiron and colleagues (2018) noted that survivors of critical illness often experience various problems that begin in the intensive care unit (ICU) or present and continue after discharge. These could include muscle weakness, cognitive impairments, psychological difficulties, reduced physical function such as in activities of daily living (ADLs), and decreased quality of life. Early interventions such as mobilizations or active exercise, or both, may diminish the impact of the sequelae of critical illness. Ina Cochrane review, these investigators evaluated the effects of early intervention (mobilization or active exercise), commenced in the ICU, provided to critically ill adults either during or after the mechanical ventilation period, compared with delayed exercise or usual care, on improving physical function or performance, muscle strength and health-related quality of life (QOL). They searched CENTRAL, Medline, Embase, CINAHL, conference proceedings, reference lists of retrieved articles, databases of trial registries; and contacted experts in the field on August 31, 2017. These researchers did not impose restrictions on language or location of publications. They included all RCTs or quasi-RCTs that compared early intervention (mobilization or active exercise, or both), delivered in the ICU, with delayed exercise or usual care delivered to critically ill adults either during or after the mechanical ventilation period in the ICU. Two researchers independently screened titles and abstracts and assessed full-text articles against the inclusion criteria of this review. The authors resolved any disagreement through discussion with a third review author as required. They presented data descriptively using MDs or medians, risk ratios (RRs) and 95 % CIs. A meta-analysis was not possible due to the heterogeneity of the included studies. These researchers assessed the quality of evidence with GRADE. They included 4 RCTs (a total of 690 participants) in this review. Subject were adults who were mechanically ventilated in a general, medical or surgical ICU, with mean or median age in the studies ranging from 56 to 62 years. Admitting diagnoses in 3 of the 4 studies were indicative of critical illness, while subjects in the fourth study had undergone cardiac surgery; 3 studies included range-of-motion (ROM) exercises, bed mobility activities, transfers and ambulation. The fourth study involved only upper limb exercises. Included studies were at high risk of performance bias, as they were not blinded to subjects and personnel, and 2 of 4 did not blind outcome assessors; 3 of 4 studies reported only on those subject who completed the study, with high rates of drop-out. The description of intervention type, dose, intensity and frequency in the standard care control group was poor in 2 of 4 studies; 3 studies (a total of 454 subjects) reported at least 1 measure of physical function; 1 study (104 participants) reported low-quality evidence of beneficial effects in the intervention group on return to independent functional status at hospital discharge (59 % versus 35 %, RR 1.71, 95 % CI: 1.11 to 2.64); the absolute effect was that 246 more people (95 % CI: 38 to 567) per 1,000 would attain independent functional status when provided with early mobilization. The effects on physical functioning were uncertain for a range measures: Barthel Index scores (early mobilization: median 75 control: versus 55, low quality evidence), number of ADLs achieved at ICU (median of 3 versus 0, low quality evidence) or at hospital discharge (median of 6 versus 4, low quality evidence). The effects of early mobilization on physical function measured at ICU discharge were uncertain, as measured by the Acute Care Index of Function (ACIF) (early mobilization mean: 61.1 versus control: 55, MD 6.10, 95 % CI: -11.85 to 24.05, low quality evidence) and the Physical Function ICU Test (PFIT) score (5.6 versus 5.4, MD 0.20, 95 % CI: -0.98 to 1.38, low quality evidence). There was low quality evidence that early mobilization may have little or no effect on physical function measured by the Short Physical Performance Battery score at ICU discharge from 1 study of 184 participants (mean 1.6 in the intervention group versus 1.9 in usual care, MD -0.30, 95 % CI: -1.10 to 0.50), or at hospital discharge (MD 0, 95 % CI: -1.00 to 0.90). The fourth study, which examined post-operative cardiac surgery patients did not measure physical function as an outcome. Adverse events (AEs) were reported across the 4 studies; but these investigators could not combine the data; their certainty in the risk of AEs with either mobilization strategy was low due to the low rate of events; 1 study reported that in the intervention group 1 out of 49 subjects (2 %) experienced oxygen desaturation less than 80 % and 1of 49 (2 %) had accidental dislodgement of the radial catheter. This study also found cessation of therapy due to subject instability occurred in 19 of 498 (4 %) of the intervention sessions. In another study 5 of 101 (5 %) subjects in the intervention group and 5 of 109 (4. 6%) subject in the control group had post-operative pulmonary complications deemed to be unrelated to intervention. A third study found 1 of 150 subjects in the intervention group had an episode of asymptomatic bradycardia, but completed the exercise session; the fourth study reported no AEs. The authors concluded that there was insufficient evidence on the effect of early mobilization of critically ill people in the ICU on physical function or performance, AEs, muscle strength and health-related QOL at this time. The 4 studies awaiting classification, and the 3 ongoing studies may alter the conclusions of the review once these results are available. These researches stated that that there is currently low-quality evidence for the effect of early mobilization of critically ill adults in the ICU due to small sample sizes, lack of blinding of participants and personnel, variation in the interventions and outcomes used to measure their effect and inadequate descriptions of the interventions delivered as usual care in the studies included in this Cochrane Review.

Scope of Policy

This Clinical Policy Bulletin addresses early intervention programs.

Policy Limitations and Exclusions