None listed
Conditions
Brief summary
Parent-child interactions comprise one of the most profoundly influential experiences in a child’s development, and the quality of these interactions during early infancy in particular can have a lasting impact on neurodevelopment. This randomised controlled trial is a two-arm (Treatment vs Control), single blind (assessor) randomised controlled trial to test the efficacy of a new intervention designed to promote parent sensitivity and responsiveness to their newborns with a family liability for Autism Spectrum Disorder. We hypothesise that the newborn intervention will decrease parental directiveness and increase parental sensitivity during parent-infant interactions when measured when the baby is 9 months of age, and decreases the severity of autistic symptoms, and improve a range of child development outcomes, when measured when the baby is 2 years of age.
Interventions
The Communicating and Understanding your Baby (CUB) intervention was developed by the study team using existing knowledge of typical and atypical social communication development, human and non-human primate studies of early life predictors of later social communication skills, and evidence based strategies for promoting early social engagement in the infant. The theoretical premise of the CUB program is that a responsive communication partner who is sensitive to a baby’s developmental stage and abilities provides the optimal environment to nurture the social and communication development of the baby. Similar to the iBASIS-VIPP therapy framework, CUB employs a ‘carer-mediated’ delivery mechanism and the use of video feedback to coach parents to understand the social and communication cues of their baby, and to respond in ways that have been shown to promote further communication. The therapy program involves one antenatal session in the third pregnancy trimester, and 10 postnatal sessions from when the infant is 4 weeks to 8 months of age. The antenatal session is a single psychoeducation group seminar (3 hours in length), hosted in a community clinic, with an ideal group size of 4 - 6 sets of parents. The group is led by a facilitator, who introduces the therapy rationale and requirements, demonstrates the range of a newborn’s skills and capacities, illustrates how influential parents are to babies’ social and communication development; and prepares parents to learn their baby’s communication behaviours from birth. A range of videos are used to highlight these key points. The postnatal sessions commence when the infant is 4 weeks of age, and there are 7 core sessions up to when the baby is 5 months of age. Each session is approximately 1 hour in length, and will be delivered by either child health nurses or speech pathologists. The sessions commence at fortnightly intervals (4 weeks to 10 weeks) but then progress to monthly intervals (3 months to 5 months). Each core session focuses on a single theme, based on the developmental stage of the baby. The first core session involves the delivery of the Newborn Behavioural Observation (NBO) system, a structured set of activities designed to help the clinician and parent to observe the baby’s unique behavioural capacities. The NBO consists of 18 activities designed to direct the caregiver’s attention toward the infant’s behaviours. The items include observations of the infant's capacity to habituate to light and sound, the quality of motor tone and activity level, the capacity for self regulation, and the infant's visual, auditory, and social-interactive capacities. There is currently low-quality evidence that the NBO improves sensitive and contingent responding of parents during infant interactions. Core sessions 2 to 7 all follow a similar structure, consisting of an initial review of the baby’s development since the previous session, the filming of a video of the parent and baby interacting, review of the video with the parent, and a summary discussion of the session. The video recordings of parent-baby interactions are built around everyday activities for newborns (e.g., feeding, settling, nappy changes and dressing) and infants (singing nursery rhymes, playing with toys, and sharing books). The program allows a high degree of flexibility when identifying filming contexts, particularly in the early postnatal sessions. The filming context is jointly agreed by the parent and clinician, and appropriate to the baby’s state of alertness and the baby’s needs at the time. The clinician video records the parent interacting with their baby. During filming, the clinician observes the dyad and, being mindful of the session theme, identifies key messages to be communicated during the video review. The clinician then watches the video through themself, prior to reviewing the video with parents, while the parent attends to the baby. The parent and clinician then review the video in its entirety, with the clinician pausing the video to highlight key moments of the interaction. A range of video feedback techniques are used by the clinician to help the parent reflect on his/her interactions with the baby, the responses of the baby to the interaction, and how they might tailor their own behaviours to optimise the interactions. Following the completion of the core sessions when the baby is 5 months of age, there are three focused sessions at monthly intervals which serve to reinforce key interaction strategies important for the individual dyad, as well as target any areas of infant social communication development where there may be an identified concern or difficulty. The sessions are structured similarly to the core sessions. Trial therapists will complete a four-day training course, delivered by the developers of the intervention, which will include theoretical background, clinical observations, and practical opportunities. Trial therapists will receive fortnightly supervision by the lead clinician for the trial (MR), who will also coordinate across-site therapist meetings. All interventions sessions will be videotaped, and a random selection of 5% of videotapes will be independently rated for fidelity using a scale developed for this trial. Compliance in the ‘treatment’ condition will be monitored via a case report form completed by the clinician at each therapy session.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion criteria for the trial are: (a) Pregnant woman (eligible inclusion answer = Yes) (b) Carrying a singleton pregnancy (eligible inclusion answer = Yes); (c) Carrying a foetus with a relatively ‘high’ or ‘moderate’ likelihood of developing ASD based on the following criteria (eligible answer = Yes): • High likelihood: The foetus has a biological mother, biological father, or full sibling with a clinical diagnosis of ASD. The diagnosis of the ‘proband’ (index case with the autism diagnosis) is confirmed by a copy of the diagnostic report. • Moderate likelihood: The foetus has a biological mother, biological father or full sibling with ADHD or intellectual disability (with no known cause), OR a biological grandparent, biological uncle/aunt, half sibling with autism. The diagnosis of the ‘proband’ (index case with the autism, ADHD or intellectual disability diagnosis) is confirmed by a copy of the diagnostic report. (d) To the best of their knowledge, the primary carer and offspring are intending to remain in the Perth or Melbourne metropolitan area for the next two and a half years (eligible inclusion answer = Yes); and (e) English is the main language spoken at home (eligible inclusion answer = Yes).
Exclusion criteria
Exclusion criteria for the trial are: (a) The foetus/offspring has been diagnosed with a serious medical condition requiring ongoing care, as determined by the study team (exclusion answer = yes). (b) The proband has a known genetic mutation associated with their clinical diagnosis (e.g., tuberous sclerosis complex, PTEN mutation etc.) that isn’t typically inherited (exclusion answer = yes). (c) The primary carer has a serious mental or physical health condition requiring ongoing care, as determined by the study team (exclusion answer = yes).