The study «Whitehouse AJO, Varcin KJ, Pillar S ym. Effect of ...»1 investigated the effects of early intervention on small children showing early signs of autism. The intervention iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP) uses video feedback techniques to increase caregiver awareness of their infant’s individual social communication and guide specific caregiver responses to build infant social engagement and interaction. The intervention involved 10 sessions delivered in family homes by a trained therapist over a 5-month period. Caregiver-infant interactions were videotaped during each session, which provided the basis for video feedback discussion. Core aspects of the iBASIS-VIPP intervention included (1) a focus on the social-communicative aspects of each parent-infant dyad, (2) viewing of videotaped interaction excerpts that provided positive examples of infant behaviors and responsive caregiver interactions, and (3) therapist framing of observations, assistance with caregiver self-reflection, and focus on change in the caregiver’s communicative responses to the infant. Caregivers were asked to undertake daily home practice using targeted skills when interacting with their infant.
Assessments were conducted at baseline, 6 months after baseline (treatment end point), 12 months after baseline, and 24 months after baseline.
Families were referred by community clinicians and invited to participate if (1) the infant was between age 9 months and less than 15 months (corrected for prematurity) at eligibility screening, (2) the infant displayed at least 3 of 5 specified behaviors indicating a high likelihood of ASD as defined by the Social Attention and Communication Surveillance–Revised (SACS-R) 12-month checklist.
Infants were randomized to receive either the iBASIS-VIPP intervention plus usual community care or usual community care only with a computer algorithm. Usual community care comprised services recommended by health professionals within the local community, including a range of allied health services, comprehensive autism interventions, or no services. Fifty infants received the intervention and 53 infants were in the control group.
Outcome measures: The primary outcome was ASD symptom severity over time. The Autism Observation Scale for Infants (AOSI) was used to measure early behavioral signs associated with ASD and the Autism Diagnostic Observation Schedule, second edition (ADOS-2) was used at the 12-month and 24-month postbaseline assessments to measure ASD behaviors measured at the beginning and at the end of the intervention.
Secondary outcome measures at 24 months after the intervention were 1) clinical evaluation by two independent clinicians who were experienced in ASD diagnosis and blinded to group allocation using the Diagnostic and Statistical Manual of Mental Disorders criteria. The diagnostical categories were analyzed as 3 groups: clinical ASD (representing definite ASD), atypical development (representing possible ASD or other developmental concerns), and typical development (representing no developmental concerns). 2) The Manchester Assessment of Caregiver-Infant Interaction (MACI), which is a global rating measure of a 6-minute parent/caregiver and infant play session and 3) the Mullen Scales of Early Learning, a standardized assessment of developmental abilities, The Vineland Adaptive Behavior Scales, The MacArthur Communicative Development Inventories and Parenting Sense of Competence (PSOC) scale.
Results: There was a growing treatment effect (reduced ASD symptom severity, primary outcome) favoring the iBASIS-VIPP group from treatment end point to the 12-month postbaseline assessment, which was largely maintained at the 24-month postbaseline assessment. The combined treatment effect estimate across time points was statistically significant (ABC, −5.53; 95% CI, −∞ to −0.28; P = .04).
Concerning the clinical evaluation, between-group comparisons found that the iBASIS-VIPP group had lower odds of meeting DSM-5 criterion than the usual care group (odds ratio [OR], 0.21; 95% CI, 0-0.94; P = .04). A logistic regression analysis incorporating covariates identified reduced odds of meeting DSM-5 criteria A1 among the iBASIS-VIPP group (deficits in social-emotional reciprocity: OR, 0.35; 95% CI, 0-0.82; P = .02), B1 (stereotyped or repetitive movements: OR, 0.29; 95% CI, 0-0.73; P = .02), and B4 (unusual sensory interests: OR, 0.13; 95% CI, 0-0.53; P = .02). No difference between groups was found in the 3-level diagnostic classification (ASD, atypical development, and typical development). However, logistic regression analysis of the binary clinical diagnosis outcome (ASD vs no ASD) incorporating covariates identified reduced odds of ASD classification in the iBASIS-VIPP group (3 of 45 participants [6.7%]) compared with the usual care group (9 of 44 participants [20.5%]; OR, 0.18; 95% CI, 0-0.68; P = .02). The number needed to treat to reduce an ASD classification was 7.2 participants.
With regard to parent-child interaction, the initial effect of the iBASIS-VIPP intervention on increasing scores on the MACI caregiver sensitive responsiveness subscale began to attenuate at the 24-month postbaseline assessment. The combined treatment effect was statistically significant (ABC, 5.02; 95% CI, 0.02 to ∞). There was no treatment effect on the MACI subscales of caregiver nondirectiveness (ABC, 3.59; 95% CI, −1.80 to ∞), infant attentiveness (ABC, 2.09; 95% CI, −3.35 to ∞), and infant positive affect (ABC, −2.86; 95% CI, −8.30 to ∞).
Mullen Scales of Early Learning subscales was observed, but the combined effect estimates were nonsignificant for the receptive language (ABC, 4.00; 95% CI, −1.01 to ∞), expressive language (ABC, 1.55; 95% CI, −3.31 to ∞), visual reception (ABC, 3.20; 95% CI, −1.94 to ∞), and fine motor (ABC, 3.75; 95% CI, −0.89 to ∞) subscales. A similar pattern favoring the iBASIS-VIPP group (but with CIs crossing the null) was observed for VABS-II measures of functional communication (ABC, 6.21; 95% CI, −0.09 to ∞) and functional socialization (ABC, 6.26; 95% CI, −0.20 to ∞) skills. The iBASIS-VIPP group had greater improvement on the nonblinded caregiver-reported MacArthur Communicative Development Inventories subscales measuring expressive vocabulary (ABC, 8.21; 95% CI, 2.15 to ∞), receptive vocabulary (ABC, 8.10; 95% CI, 1.60 to ∞), and gestures (ABC, 6.56; 95% CI, 1.17 to ∞). There was no effect of treatment group on the efficacy (ABC, −1.62; 95% CI, −6.83 to ∞), interest (ABC, 0.18; 95% CI, −5.17 to ∞), and satisfaction (ABC, 0.53; 95% CI, −4.81 to ∞) subscales of the PSOC.
To conclude, the study found a statistically significant decrease in ASD symptoms severity among those participating the intervention compared to control group. The risk of ASD diagnosis also decreased in the intervention group compared to the control group during the follow-up time. Many outcome measures indicated no statistically significant association between the intervention group and the study group.
Comment: This is a single study of a preemptive intervention with rather small study groups, thus the findings should be considered preliminary and further studies are needeed to confirm the findings.