Intervention within the British Autism Study of Infant Siblings (iBASIS)

• Register: ISRCTN
• Last refreshed on: 30 October 2017
• Main ID: ISRCTN87373263
• Date of registration: 10/11/2011
• Prospective Registration: No
• Primary sponsor: University of Manchester (UK)
• Public title: Intervention within the British Autism Study of Infant Siblings (iBASIS)
• Scientific title: Intervention within the British Autism Study of Infant Siblings (iBASIS): a pilot single-blinded randomised controlled trial
• Date of first enrolment: 01/05/2011
• Target sample size: 50
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN87373263
• Study type: Interventional
• Study design: Pilot single-blinded randomised controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Jonathan Green

Key inclusion & exclusion criteria

Inclusion criteria: 1. Families live within therapist travel distance
2. Aged between 0 and 9 months at the time of referral
3. Have older sibling diagnosed with an autism spectrum disorder (ASD)
4. English spoken at home
Exclusion criteria: 1. Child does not meet BASIS and iBASIS criteria
2. Known genetic or cognitive impairment
3. More than one infant

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Autism Spectrum Conditions
Mental and Behavioural Disorders
Autism

Intervention(s)

Two parallel groups: intervention and non-intervention. Research assessments will be made independently and blind to treatment status.

The iBASIS intervention would take place in families' homes and would involve visits from a trained therapist. The iBASIS programme lasts 5 months: there are 10 sessions in total - 1hr each. The first six sessions will be weekly at the famiy's home. The following four will be separated by three weeks.

Each session will involve the therapist making a video recording of the parent and infant interacting and playing in a natural setting at home for a period of about 6 minutes. The therapist and parent will watch the video recordings together and parents will receive detailed feedback from the therapist about features of the interaction.

We look at how opportunities for communication could be enhanced. We also agree how parents might be able to explore more and practice the things we discuss in between these sessions; and the programme aims that parents will be able to do about 30 minutes of such 'practice' daily.

During each session the therapist will explain clearly what the parent will be doing and parents will be able to ask questions at any time.

Primary Outcome(s)

Autism Observation Scale for Infancy (AOSI): a validated instrument designed to measure developmental atypicality. It has shown predictive validity to later diagnosis of autism.

Secondary Outcome(s)

1. Coding of parent-child interaction: Global and micro measures of the parent-infant interaction coded from a free-play session. The coding aims to assess the impact of the i-BASIS intervention on parental sensitive responsiveness and dyadic mutuality.
2. Neurophyisological and brain biomarkers: The infant will complete a range of assessments including their response to social stimuli and gaze patterns
3. Qualitative analysis of parent intervention to address subjective impact of intervention

Secondary ID(s)

7267

Source(s) of Monetary Support

Autistica (UK) protocol ref: 7267, The Waterloo Foundation (UK) ref: 770-1025