SCOPE for improvement of direct care in early childhood: A Social COmmunication Programme supported by E-health for early identification and intervention of social communication problems possibly associated with autism in primary care

Autism Spectrum Disorders (ASD) are recognized rather late in the Netherlands,
as elsewhere, which delays adequate early intervention. Growing scientific
evidence indicates that early intervention improves long-term outcomes and
reduces negative consequences such as comorbid problems, negative impact on
families and high societal costs. The Social COmmunication Programme supported
by E-health (SCOPE) aims to improve quality and efficiency of care, to
accelerate procedures and to optimize collaboration between the
youth-healthcare (JGZ) and the specialized mental healthcare (S-GGZ), so that
timely detection of ASD followed by an early start of adequate intervention
will be made possible.
SCOPE includes (1) raising awareness via an online platform for parents and
professionals, (2) training and consultation for primary care providers, and
(3) a short home-based early intervention named BEER (Blended E-health for
children at Early Risk). BEER is a parent training will be offered to parents
of children (12-30 months) who are screened positive (and are therefore at risk
for ASD) in regular well-baby clinic visits. The training will be offered
before a full diagnostic assessment program has been performed. In this
submission, we will only focus on the third goal of SCOPE.

Primary Objective:
The main objective of this study is to investigate the effectiveness of BEAR (a
parent training combining e-learning and home visits) compared to care-as-usual
(CAU) in young children (12-30 months) who are at risk of developing ASD, in a
cluster randomized controlled trial.

The primary research question is:
1) What is the effectiveness of BEAR compared to CAU in terms of change in
joint engagement in the parent child interaction, directly after the treatment
at 8 weeks, and at follow-up at 24 weeks?

Secondary research questions are:
2) What is the effectiveness of BEAR, compared to CAU, in terms of the
social-communicative development of the child?
3) What is the effectiveness of BEAR, compared to CAU, in parental intervention
skills and parental well-being?
4) What is the effectiveness of BEAR, compared to CAU, in terms of parental
satisfaction about care?
5) What is the effectiveness of BEAR, compared to CAU, in time between first
concerns of ASD and start of intervention?

First, we will conduct a pilot study. In this pilot study, two well-baby clinic
locations in Nijmegen (in Dukenburg and Oud-west) and two-well baby clinic
locations in the province of Utrecht (in Oudewater and Houten) will be
included. In this pilot study, we aim to test the feasibility of the proposed
research design in a small sample (N=10).

The actual design of the study is a cluster randomized controlled trial (RCT)
starting in the Nijmegen area with clusters defined by a number of well-baby
clinic locations in the city of Nijmegen and surrounding areas, affiliated with
GGD Gelderland Zuid. It is expected that we will, as a next step in the study,
also include well-baby clinics from the province of Utrecht.

The BEAR parent training is a blended e-health intervention offered to children
(12-30 months) who are considered to be at risk for ASD based on screen
positive results on the CoSoS (*3) or based on clinical judgement, and their
parents. The intervention consists of 7 home visits and 5 e-learning sessions
and will be delivered by a JGZ-professional, under supervision of a
(S)GGZ-professional. During the first and the last visit, the
(S)GGZ-professional will accompany the JGZ-professional. For a specific outline
of BEAR see Table 2 on p. 19 of the research protocol.

To our knowledge, the SCOPE program and BEAR. are not associated with any risk
for the patient. Burden is estimated as low (see p. 36)