Autism Spectrum Disorder, Cognitive Behaviour Therapy
Conditions
Brief summary
Sleep disturbance is very common in children with autism spectrum disorder (ASD),and closely associated with their core symptom, social deficit.This trial investigates the effects of Cognitive behaviour therapy for insomnia (CBT-I) in children with autism spectrum disorder with sleep problems through synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS). This is a 1:1 parallel single-blind randomized controlled trial.
Detailed description
sleep disturbance is significantly associated with social deficit of ASD and but the congnitive-neural mechanism underlying this association remains unclear. Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia. After 5 consecutive sleep interventions is a 2-year following up study, the above issue is further tested with emphasis on progressive trajectory from a developmental perspective. we examine the influence of sleep disturbance on face processing and neural response during naturalistic social behavior of ASD children using synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS) to uncover the neural mechanism for that sleep disturbance influences social deficit.
Interventions
BEHAVIORALCognitive behaviour therapy for insomnia
CBT-I for children with ASD includes sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. The treatment consists of 5 weekly modules.
BEHAVIORALpsychoeducation for ASD
psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant blind
Intervention model description
1:1 parallel randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
24 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
1. meet the diagnostic criteria for autism DSM-5 and ADOS-2; 2. age 24months to 59months s old; 3. willing to participate in this study, and can complete the following assessments at the specific time.
Exclusion criteria
Exclusion of severe respiratory diseases, schizophrenia, epilepsy and other brain diseases;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| congnitive-neural outcomes | changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds | The investigators examine the influence of sleep disorders on face processing and neural response at baseline, 6 months after the intervention, 12 months after the intervention and when children 6 year olds by synchronized eye-tracking and functional near-infrared spectroscopy (fNIRS) to uncover the neural mechanism for that sleep disturbance influences social-emotional development. |
| ADOS-2 | changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds | The ADOS-2 is the standard instrument for assessing autism spectrum disorders (ASD) across age, developmental level, and language skills. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep diaries by using Actigraphy | changes from baseline, 6 months after the intervention, 12 months after the intervention and 6 year olds | Different sleep parameters, such as sleep onset latency (SOL) and wake after sleep onset (WASO) will be determined using wrist actigraphy. Participants will be provided with an actiwatch at baseline, 6 months after the intervention , 12 months after the intervention and when children 6 year olds . The actiwatch will be worn on the non-dominant arm 24 hours a day, except for while bathing, during the 1-week screening periodmovement and nighttime sleep parameters. |
Countries
China
Contacts
Primary ContactFan Jiang, PhD
Outcome results
None listed