None listed
Conditions
Brief summary
Autism Spectrum Disorder (ASD) is a lifelong developmental disorder affecting more than 1% of people. Social and communication therapies during early childhood are critical for promoting favourable longer-term outcomes in ASD. However, until very recently we have not had interventions tailored towards infants (<14 months of age) who are at increased risk for ASD. iBASIS-VIPP is a parent-mediated intervention in which therapists use video-feedback to help parents adapt to their infants’ interactive styles and promote optimal social and communicative development. Previous research has also shown that the iBASIS-VIPP protocol has preliminary efficacy for improving the developmental outcomes among infants who are at high risk of developing ASD because an older sibling had the condition. The next stage of this research programme is to test the iBASIS-VIPP intervention with infants presenting to a clinical setting with ASD risk-behaviours, such as social and communication delays. The study design is a two-site (Perth, Melbourne), two-arm (‘Treatment as Usual’, ‘iBASIS-VIPP'), single-blind (rater) randomized controlled trial (RCT). We will recruit 132 infants (n = 66 at each site) who are between 9 and 14-months of age and showing ASD-risk behaviours (social and/or communication difficulties). Consenting families will be randomized into receiving either the ‘iBASIS-VIPP Therapy’ (n = 66) or ‘Treatment as Usual’. Families in the ‘iBASIS-VIPP Therapy’ group will receive 10 home-based sessions with a Speech Pathologist or Psychologist over five months, and undertake 30-minutes daily home practice. Families in the ‘Treatment as Usual’ group may receive a parent information seminar, the provision of reading material on infant development, or developmental monitoring, which is the current ‘best practice’ protocol for these infants. Infants in both groups will be re-assessed follow-up points, time-locked to baseline assessments: (1) 6 months post-baseline (i.e., immediately post ‘treatment’ period), (2) 12- months post-baseline, and (3) 24-months post-baseline. The primary outcome will be autistic symptom severity immediately post treatment (measured by the AOSI). Secondary outcomes will be a range of social and communicative behaviours relevant to ASD at each of the three follow-up points.
Interventions
The intervention, called iBASIS-VIPP (Green et al.,, 2013; 2015), focuses on enriching social and communication exchanges between an infant and their caregiver. The manualised intervention will be delivered in family homes by a Research Therapist (Speech Pathologist/Psychologist). One parent will be asked to participate in all of the therapy sessions. They will receive 10 X 1.5-2 hours sessions over five months. During therapy sessions, parent and infant are videotaped during daily interactions
The intervention, called iBASIS-VIPP (Green et al.,, 2013; 2015), focuses on enriching social and communication exchanges between an infant and their caregiver. The manualised intervention will be delivered in family homes by a Research Therapist (Speech Pathologist/Psychologist). One parent will be asked to participate in all of the therapy sessions. They will receive 10 X 1.5-2 hours sessions over five months. During therapy sessions, parent and infant are videotaped during daily interactions. Video feedback provides the opportunity to focus the caregiver’s attention on the infant’s communicative signals and expressions, thereby stimulating skills for observing and empathising with the child. Core methods include:(1) a focus on the communicative aspects of the particular parent-infant dyad; (2) viewing ‘successful’ excerpts from videotaped interactions, providing positive examples of sensitive parenting; and (3) involvement of a trained therapist to frame observations to assist self-reflection, and to focus behavioural change. Intervention content focusses on enhancing parental observation, attributing communicative intent to infant behaviours that may be difficult to interpret, and facilitating responses that will build infant interaction. To this foundation, we have added components that have been tested in our previous ASD intervention studies, focusing on promoting early social communication skills, such as joint attention and turn-taking. Parents will also be asked to undertake 30-mins daily home practice in interacting with their infant using the newly learned skills, and document the quantity of home practice they undertake. As with the Treatment as Usual group, we will also quantify and qualify any contact the families have with other health professionals. References: Green J, Wan M, Guiraud J, Holsgrove S, McNally J, Slonims V, et al. Intervention for infants at risk of developing autism. J Autism Dev Disord. 2013;43(11):2502-14. Green J, Charman T, Pickles A, Wan MW, Slonims V, et al. Parent-mediated intervention versus no intervention for infants at high risk of autism. Lancet Psychiatr. 2(2):133-40.
Sponsors
Telethon Kid's Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
9 Months to 14 Months
Healthy volunteers
Yes
Inclusion criteria
Infants will be offered participation in this trial if they: (a) Are between 9 and 14 months of age; (b) Endorsement of three or more of the ‘key items’ on the 12-month old SACS-R screening questionnaire (Barbaro & Dissanayake, 2010): absent/atypical pointing, waving, imitation, eye contact, response to name. (c) The primary caregiver involved in the trial speaks sufficient English to: (i) understand the requirements of the study, and (ii) is deemed to be able to participate fully in the therapy sessions. Reference: Barbaro J, Dissanayake C. Prospective identification of ASD in infancy and toddlerhood using developmental surveillance. J Dev Behav Pediatr. 2010;31(5):376-85
Exclusion criteria
Participants will be excluded from the study if they meet either of the following characteristics: (a) The infant has a diagnosed comorbidity known to affect neurological and developmental abilities (e.g., preterm birth < 32 weeks, cerebral palsy, Down syndrome, Rett syndrome, other chromosomal abnormality, hearing/visual impairment), and/or (b) The family does not intend to remain living in the Perth/Melbourne areas for the next two years.
Outcome results
None listed