None listed
Conditions
Brief summary
Autism Spectrum Disorder (ASD) is a lifelong developmental disorder that typically emerges over the earliest years of life. 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 show early signs of ASD. While there is emerging evidence for the effiicacy of these interventions, there remains several challenges in their broader community implementation. Amongst the most significant challenges is that the efficacy of many programs depends on considerable therapy time with trained clinicians. This time requirement, and associated substantial financial expense, means that a significant proportion of families are unable to access these programs. To enhance the translational potential of very early interventions into the public health system, we have developed a more cost-effective model of therapy that is delivered in groups. We aim to test the efficacy of this parent-mediated group therapy in a randomised controlled trial (RCT) as compared to current best practice (i.e., treatment as usual). Participants (n = 80) will be infants (aged between 7 months to 14 months, 31 days) showing early social communication delays. Consenting families will be randomised into receiving either the parent-mediated group therapy (n = 40) or treatment as usual (n = 40). Families in the 'experimental' group will receive between 7-9 sessions with a speech pathologist or psychologist (1 individual session pre-group, 5 weekly group sessions, 1 individual session post-group, plus the option of 2 additional individual booster sessions, if indicated). Families in the ‘treatment as usual’ group will receive current treatment protocol offered within the community, which may comprise a parent information seminar, the provision of reading materials on infant development, or any indicated services such as speech and language therapy, occupational therapy, or physiotherapy. Infants in both groups will be assessed at baseline (i.e., prior to being randomised to an intervention arm) and at immediate treatment endpoint (time-locked to six months after their baseline assessment).
Interventions
This parent-mediated group intervention focuses on enriching social and communication exchanges between an infant and their caregiver. The intervention is delivered by a Research Therapist (i.e., speech pathologist or clinical psychologist), and comprises between 7 and 9 sessions: an initial one-on-one session (1-2 hours) that takes place in the family home two weeks before the group therapy commences, five weekly group-based sessions (2-hours per session), and a follow-up one-on-one booster ses
This parent-mediated group intervention focuses on enriching social and communication exchanges between an infant and their caregiver. The intervention is delivered by a Research Therapist (i.e., speech pathologist or clinical psychologist), and comprises between 7 and 9 sessions: an initial one-on-one session (1-2 hours) that takes place in the family home two weeks before the group therapy commences, five weekly group-based sessions (2-hours per session), and a follow-up one-on-one booster session (1-2 hours) occurring within a home setting four weeks after the final group therapy session. There is also the option of up to two additional individual booster sessions (at 4-weekly intervals), if required. Group sessions are delivered in a small-group setting (caregivers only) with four to six families per group. Group sessions are attended by parents only. The group intervention uses videotapes of the parent and infant engaging in everyday interactions, which form the basis of a video feedback discussion. The videos included in each session are a mixture of 'stock' videos of parents not involved in the group, and videos of parents involved in the group (recorded during the preceding week). 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 communicative bids by infants; (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 focuses on enhancing parental observation, attributing communicative intent to infant behaviours that may be difficult to interpret, and facilitating responses that will build infant interaction. The group-based sessions also offer parent-to-parent support, for which there is empirical evidence of the benefits of this type of peer support for families with children with developmental difficulties. As with the Treatment as Usual group, we will also quantify and qualify any contact the families have with other health professionals through a monthly diary completed by parents.
Sponsors
Telethon Kids 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
7 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
Infants will be offered participation in this trial if they: (a) Are between 7 months, 0 days and 14 months, 31 days of age (corrected for those infants born <37 weeks gestation); (b) Endorsement of three or more of the ‘key items’ on the 8-month (for infants 7mo, 0 days – 10mo, 31 days) or 12-month (for infants 11mo, 0 days – 14mo, 31 days) SACS-R. (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.
Exclusion criteria
Participants will be excluded from the study if they meet any 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 area for the next 12 months. (c) Any active court proceedings or special care arrangements (e.g., children in care of the state or situations where there is not a consistent, long-term caregiver) that may impact on participation in the study
Outcome results
None listed