SAFE, a new therapeutic intervention for families of children with autism: study protocol for a feasibility randomised controlled trial

IntroductionIncidence of autistic traits, mental health problems, stress and poor coping is high among family members of children with autism. These problems are coupled with challenging behaviour among children with autism. Current treatment for these families is disjointed and costly. The need for whole family support is supported by the National Institute for Health and Care Excellence recommendations, developments regarding children’s service provision, research and requests by families of children with autism. Despite evidence that family therapies can provide benefits to these families, efficacy has not been subject to a randomised controlled trial. Systemic Autism-related Family Enabling (SAFE) is a new family therapy intervention designed specifically for families of children with autism. We aim to establish the feasibility of running a fully powered randomised controlled trial to evaluate SAFE.Methods and analysisFamilies of children with autism aged 3–16 years will be invited to participate. Consenting participants will be randomised 2:1 to either SAFE+support as usual or support as usual alone. The proposed primary outcome measure for the main trial will be the Systemic CORE 15. Participants will also complete proposed secondary outcome measures, indexing changes in child behaviour, child-parent attachment, anxiety and depression. Generic health economic outcome measures (EuroQol 5 dimensions and Child Health Utility 9 Dimensions) will also provide data on the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline and 32 weeks post-allocation. Data on ability to identify, recruit, randomise, retain and collect data from families, acceptability of outcome measures, adherence of therapists and families to the intervention, appropriateness of resource use questionnaires and effectiveness of training will be collected for feasibility analysis. Qualitative data will also explore acceptability of SAFE and reasons for declining and withdrawing from the study.Ethics and disseminationThe current trial protocol received ethical approval from the South West-Exeter Research Ethics Committee (Ref: 17/SW/0192). The findings of the trial will be disseminated in collaboration with our Family Consultation Group and other partners. Findings will be shared locally, nationally and internationally through events, conferences and published papers.Trial registration numberISCTRN83964946 (Pre-results) IRAS 213527</jats:sec

SAFE, a new therapeutic intervention for families of children with autism: a randomised controlled feasibility trial

ObjectivesTo establish the feasibility of a definitive randomised controlled trial of Systemic Autism-related Family Enabling (SAFE), an intervention for families of children with autism.DesignA randomised, controlled, multicentred feasibility study.SettingParticipants were identified from three National Health Service (NHS) diagnosing centres in Plymouth and Cornwall and a community pathway.Participants34 families of a child with a diagnosis of autism severity level 1 or 2 between 3 and 16 years. Four families were lost to follow-up.InterventionsSAFE is a manualised five-session family therapy-based intervention delivered over 16 weeks and designed for families of children with autism. SAFE involves families attending five 3-hour sessions led by systemic practitioners.Primary and secondary outcome measuresThe proposed primary outcome measure was the Systemic CORE 15 (SCORE-15). Proposed secondary outcome measures: Patient Health Questionnaire-Somatic Anxiety Depressive Symptoms, the Coding of Attachment-Related Parenting for use with children with Autism, the Child Behaviour Checklist (CBCL), the Reflective Functioning Questionnaire (RFQ) and the Caregiving Helplessness Questionnaire. Outcome measures were collected at baseline and 24 weeks post randomisation.ResultsAll primary caregivers retained in the study completed the SCORE-15 at both time points. 34 of the target of 36 families were recruited and 88% of families were retained. Training for therapists was effective. Feedback revealed willingness to undergo randomisation. There was 100% attendance at appropriate sessions for core family members. The SCORE-15 showed reduction in scores for families receiving SAFE compared with controls suggesting positive change. Qualitative data also revealed that families found the study acceptable and families receiving SAFE experienced positive change. Feedback indicated that the SCORE-15 should be retained as a primary measure in a future trial, but secondary measures should be reduced.ConclusionsThis study indicates that a larger trial of SAFE is feasible. Findings suggest that SAFE can address current gaps in recommended care, can be confidently delivered by NHS staff and has potential as a beneficial treatment.Trial registration numbersISCTRN83964946 and IRAS213527.</jats:sec

Manual tracking in three dimensions.

Contains fulltext : 50618.pdf (preprint version ) (Open Access) Contains fulltext : 50618.pdf (publisher's version ) (Closed access)Little is known about the manual tracking of targets that move in three dimensions. In the present study, human subjects followed, with the tip of a hand-held pen, a virtual target moving four times (period 5 s) around a novel, unseen path. Two basic types of target paths were used: a peanut-shaped Cassini ellipse and a quasi-spherical shape where four connected semicircles lay in orthogonal planes. The quasi-spherical shape was presented in three different sizes, and the Cassini shape was varied in spatial orientation and by folding it along one of the three bend axes. During the first cycle of Cassini shapes, the hand lagged behind the target by about 150 ms on average, which decreased to 100 ms during the last three cycles. Tracking performance gradually improved during the first 3 s of the first cycle and then stabilized. Tracking was especially good during the smooth, planar sections of the shapes, and time lag was significantly shorter when the tracking of a low-frequency component was compared to performance at a higher frequency (-88 ms at 0.2 Hz vs. -101 ms at 0.6 Hz). Even after the appropriate adjustment of the virtual target path to a virtual shape tracing condition, tracking in depth was poor compared to tracking in the frontal plane, resulting in a flattening of the hand path. In contrast to previous studies where target trajectories were linear or sinusoidal, these complex trajectories may have involved estimation of the overall shape, as well as prediction of target velocity