Pilot Study of a Tailored Behavioral Intervention for Insomnia in Children with Autism Spectrum Disorder

Background:  Children with Autism Spectrum Disorder (ASD) have demonstrated elevated rates of chronic insomnia, possibly stemming from an arousal dysregulation that produces a constellation of behavioral symptoms that include anxiety, sensory differences, and difficulties sleeping. Based on the theory that a subset of children with ASD are in a hyper-aroused state, we developed a Tailored Behavioral Intervention (TAB) for insomnia to supplement the Standard Care (SC) established by the Autism Speaks Autism Treatment Network Sleep Tool Kit. The TAB developed for this study includes: (1) positive routines, (2) the Calming Module, a novel component designed to decrease arousal levels with 12 soothing, relaxing activities, (3) faded bedtime protocol, and (4) Performance feedback procedures (PFP), an effective consultative strategy used to support parents and foster study fidelity. Based on the child’s arousal profile selected activities from the CM are incorporated into the evening routine to relax the child and promote sleep.

Objectives:  

(1) Determine the feasibility of implementing randomized control trial of a TAB and SC (n = 20) or SC only (n = 20) protocol for children with ASD and insomnia, evaluating recruitment, randomization, retention, and implementation of interventions by a multi-disciplinary team with parents of a child with ASD. (2) Complete a comparative cost analysis of the interventions, in terms of training and parent resources needed to teach the interventions, measure fidelity, and collect data on the primary outcome, sleep, as measured by actigraphy. (3) Compare the effects of the interventions on sleep parameters.

Methods: Children ages 6-10 years with ASD and insomnia, stable medical conditions and daytime behaviors and their families are eligible. Measures for all participants include sleep history, 10 days of Actigraphy, sleep diary, and Sensory Profile, Children’s Sleep Habits Questionnaire, and Pediatric Anxiety Rating Scale taken at baseline, 4 and 8 weeks post-intervention, and a Parent Acceptability Survey following completion. The multi-disciplinary team develops arousal profiles for each child. SC is lead by the nurse or Occupational Therapist. Families are randomized to either TAB and SC or SC only. The TAB group receives eight one-hour home-based sessions.

Results:  

To date, 27 families have been enrolled, with completed data sets for N = 8 TAB and N = 6 SC. Protocol is very acceptable to families (Mean (M) = 6.5, Scale: 0-7) and all subjects have tolerated wearing the actigraph. Actigraphy shows TAB participants significantly increased their sleep minutes from baseline to 8 weeks (M = 43.15, standard deviation (SD) = 37.80, p = 0.016), while SC participants did not (M = -2.80, SD = 37.78, p = 1.00). Further, TAB participants decreased their sleep latency from baseline to 8 weeks (M = -13.94, SD = 14.93, p = 0.055), while SC participants did not (M = 1.05, SD = 17.93, p = 0.438)

Conclusions:  Preliminary results suggest that the TAB intervention is feasible to implement, acceptable to families, and is associated with significantly greater reductions in sleep latency and increases in sleep minutes than SC only for children with ASD and insomnia.