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. 2025 Jul 22;15(7):e101084. doi: 10.1136/bmjopen-2025-101084

Cognitive behavioural therapy and related interventions for sleep disorders in children and adults with autism spectrum disorder: protocol for a systematic review and meta-analysis

Qianyi Zhai 1,2,3, Yuxin Wu 4, Yinan Wu 4, Youyou Ji 4, Yutong Li 4, Ronglin Xu 5, Yi Zhong 4, Bin Xiao 4,✉, Lanshu Zhou 1,2,3,*
PMCID: PMC12306278  PMID: 40701602

Abstract

Abstract

Introduction

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterised by deficits in social communication and repetitive behaviours, often accompanied by sleep disturbances. These sleep problems, including prolonged sleep latency and fragmented sleep, affect more than half of autistic individuals, exacerbating functional impairments and diminishing quality of life. Cognitive behavioural therapy (CBT) has shown promise in addressing sleep disturbances in ASD, with preliminary studies indicating improvements in sleep quality. However, no systematic review has comprehensively summarised the effects of CBT on sleep in autistic individuals.

Methods and analysis

This systematic review and meta-analysis will synthesise evidence on the efficacy of CBT for improving sleep quality in individuals with ASD. We will search multiple databases (eg, PubMed, Web of Science) for studies published until May 2025. Inclusion criteria encompass randomised controlled trials, single-arm studies and observational studies involving children and adults with ASD and moderate sleep problems. Interventions targeting sleep quality using CBT techniques will be considered. Data extraction will focus on study details, participant information, intervention specifics and sleep outcome measures (eg, total sleep time, sleep onset latency, etc). Risk of bias will be assessed using tools such as Cochrane Risk of Bias Tool V.2, Risk Of Bias In Non-randomised Studies—of Interventions and Review Manager 5.3. A meta-analysis will be conducted using Stata 18, with heterogeneity evaluated using the I² statistic and Cochran’s Q test.

Ethics and dissemination

Given that the dataset for this investigation is derived from publicly accessible databases, there is no direct interaction with patients; thus, ethical approval is not required.

PROSPERO registration number

CRD42025643701.

Keywords: Protocols & guidelines, MENTAL HEALTH, Developmental neurology & neurodisability, SLEEP MEDICINE, Sleep medicine

STRENGTHS AND LIMITATIONS OF THIS STUDY.

  • Adheres to Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol guidelines and PROSPERO registration for methodological rigour.

  • Includes a broad range of studies to ensure comprehensive evidence synthesis.

  • Uses standardised tools for risk of bias assessment to ensure high-quality evidence.

  • Potential language bias, publication bias and variability in study design could affect the interpretation of results.

  • Heterogeneity in intervention delivery and outcome definitions may complicate analysis.

Introduction

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterised by persistent deficits in social communication, restricted interests and repetitive behaviours.1 Beyond these core symptoms, ASD is frequently accompanied by comorbid conditions, with sleep disturbances emerging as one of the most prevalent and clinically significant challenges. Epidemiological studies estimate that 50–90% of autistic individuals experience sleep problems—such as prolonged sleep latency, fragmented sleep and reduced sleep efficiency—compared with 25–50% in neurotypical populations.2,4 These disturbances often persist across the lifespan, exacerbating functional impairments and diminishing quality of life.5 6 Critically, disrupted sleep in ASD is strongly associated with heightened internalising and externalising symptoms, including anxiety, affective dysregulation and behavioural challenges.7,9

The bidirectional relationship between sleep and psychopathology in ASD remains poorly understood. For instance, anxiety has been identified as a robust predictor of sleep disruption, while sensory sensitivities, gastrointestinal symptoms and circadian rhythm abnormalities further compound these issues.10,12 Conversely, insufficient sleep may amplify stress responsivity and emotional lability, creating a cyclical interplay that worsens both sleep and daytime functioning.13 Recent meta-analytic findings underscore this complexity, revealing that sleep problems in ASD correlate most strongly with mood disorders and anxiety symptoms, though causal pathways remain elusive.7 14 15 Longitudinal and intervention-based studies are urgently needed to disentangle these dynamics and identify modifiable treatment targets.

Cognitive behavioural therapy (CBT) is a collaborative psychological treatment delivered through various formats, such as individual or group sessions, with varying degrees of parental or family involvement.16 It targets cognitive, behavioural and emotional patterns that contribute to various issues, including sleep problems, and can focus on changing negative sleep-related thoughts and forming healthy habits as part of its application to address sleep difficulties. Early CBT programmes included psychoeducation, cognitive restructuring, exposure therapy, social skills training, coping strategies and self-reinforcement. Alternative approaches involve training parents to deliver CBT strategies to their children, known as guided parent-delivered CBT.17 18 This method provides parents with the tools to implement CBT techniques in their child’s daily life. To adapt CBT for children with ASD, modifications have been made to incorporate visual aids, social stories, structured activities and behavioural coaching.19 20 Programmes designed for this population include multimodal anxiety and social skills intervention 21 and facing your fears.22 These adapted programmes aim to address the unique challenges faced by children with ASD while maintaining the core principles of CBT.

CBT, a first-line intervention for anxiety in autistic youth,20 23 holds promise for addressing sleep disturbances. In neurotypical populations, anxiety-focused CBT has demonstrated secondary benefits for sleep, reducing insomnia and improving sleep hygiene.24 25 Preliminary research on ASD and CBT further supports this effect. For example, McCrae et al26 conducted a pilot single-arm study showing that eight face-to-face sessions of CBT for insomnia (CBT-I) improved sleep efficiency and sleep onset latency (SOL) in 17 children with autism and comorbid insomnia. The results were validated by actigraphy, confirming the reliability of self-reported data. In their subsequent study (2021),27 the feasibility of telehealth-based CBT-I was further confirmed. Fourteen children completed the treatment and showed sustained improvements in sleep indices, with effects maintained at a 1 month follow-up. Additionally, Cortesi et al 28 conducted a randomised controlled trial (RCT) (n=144) and found that a combined intervention of controlled-release melatonin and CBT reduced SOL and wake after sleep onset (WASO) over 12 weeks, with better efficacy than either monotherapy or placebo. Tanksale et al 29 explored a 6 week programme integrating yoga with third-generation CBT in a pilot RCT (n=67). The results showed that the intervention group outperformed the treatment-as-usual control group in terms of sleep anxiety and night awakenings. In China, Zhang Ying30 expanded the application of CBT in an RCT (n=102) by combining group CBT with repetitive transcranial magnetic stimulation. After 12 weeks, the experimental group showed better scores on the Pittsburgh Sleep Quality Index (PSQI) and the Aberrant Behaviour Checklist compared with the routine rehabilitation group. These studies collectively indicate that CBT and its derivative intervention strategies (such as remote implementation and multimodal combinations) have cross-cultural and multiscenario applicability in improving sleep problems in children with autism, with sustained effects shown in short-term follow-ups (1–6 months).

However, there is no systematic review on the subject to summarise effects of CBT on sleep of autistic patients. Thus, this systematic review and meta-analysis aims to synthesise existing evidence on the efficacy of CBT in improving sleep quality among autistic individuals.

Methods and analysis

Design and study registration

The methodology for this systematic review has been designed to adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol (PRISMA-P) guidelines,31,33 ensuring a rigorous and transparent approach throughout the study design and reporting phases. The protocol has been formally registered with the International Prospective Register of Systematic Reviews (PROSPERO),34 35 with the registration identifier CRD42025643701.

Eligibility criteria

Types of studies

The types of studies in this review include RCTs, single-arm studies, quasi-RCTs and observational studies that investigate the effects of CBT on sleep disorders in individuals with ASD. To preserve the rigour and integrity of the evidence base, studies exhibiting suboptimal design, deficiencies in randomisation or statistical techniques, data aberrations, incomplete datasets, redundant publication and discrepancies in baseline characteristics will be rigorously excluded from our analysis.

Language

In this review, we shall strive to locate and include pertinent studies published in any languages, if practicable.

Types of participants

Inclusion criteria

  1. Children and adults diagnosed with ASD1 (assessed by Autism Diagnostic Interview—Revised36 and/or Autism Diagnostic Observation Schedule.37

  2. Aged 3 years and older,38 regardless of gender or ethnicity.

  3. For infants and young children (0–3 years of age), the brief infant sleep questionnaire can be used as a screening tool.39 A clinical referral should be considered if a child meets any of the following criteria:

    1. The child wakes up ≥3 times per night.

    2. The child spends ≥1 hour in wakefulness during the night.

    3. The child’s total sleep time (day and night) is ≤9 hours.

  4. For children aged from 4 to 12 years, the Children’s Sleep Habits Questionnaire (CSHQ) score is greater than 41 points.40

  5. For adolescents aged more than 13 years and adults, Insomnia Severity Index (ISI) score is greater than eight points41 and/or PSQI total score is greater than five points.42 43

Exclusion criteria

Participants will be excluded if they had any of the following conditions:

  1. Other sleep disorders (eg, sleep-disordered breathing, restless legs disorder, periodic limb movement disorder, circadian rhythm sleep disorders).

  2. Neurological or psychiatric disorders (eg, seizure disorder, bipolar disorder or other major psychopathologies such as suicidal ideation/intent, psychosis).

  3. Comorbid conditions other than depression or anxiety.

Additionally, participants will be excluded if they were receiving any of the following treatments or interventions:

  1. Antimicrobial therapy for chronic or severe infectious diseases, including HIV, tuberculosis (TB) or other clinically significant infections such as influenza, respiratory syncytial virus (RSV) or COVID-19.

  2. Chemotherapeutic agents for cancer or other chronic illnesses.

  3. Medications that may affect sleep, such as psychotropic drugs, sedatives or stimulants.

  4. Participation is currently on other psychotherapy or other behavioural interventions targeting sleep, such as light therapy, physical therapy or family therapy.

  5. Children with severe cognitive impairments or intellectual disabilities.

Types of interventions

Given the heterogeneity of interventions in ASD populations, this review adopts a broad definition to capture both traditional CBT and interventions integrating CBT elements.

Inclusion criteria

This systematic review will include interventions aimed at enhancing sleep quality in patients with ASD, including but not limited to the following:

  1. Sleep hygiene education: interventions that focus on educating families about good sleep practices and personalised sleep schedules.

  2. Bedtime routines and parental management: strategies that establish consistent bedtime routines and teach parents how to manage their child’s sleep initiation.

  3. Cue control: approaches that address environmental cues affecting sleep and reinforce parental management techniques.

  4. Co-sleeping and parent fading: methods that involve the gradual withdrawal of parental presence to encourage independent sleep.

  5. Circadian rhythm education: interventions that provide information on the impact of circadian rhythms on sleep.

  6. Cognitive therapy and relaxation techniques: techniques that address distorted sleep-related thoughts and include relaxation exercises tailored to individual preferences.

  7. Management of nighttime worries and anxieties: cognitive-behavioural approaches to manage nighttime concerns, including cognitive restructuring and relaxation exercises.

The review will also consider interventions that have adapted specifically for patients with ASD, which may encompass:

  1. Sensory considerations: attention to sensory issues that may impact sleep quality.

  2. Integration of special interests: incorporation of the child’s interests to increase engagement with interventions.

  3. Behavioural reinforcement: use of rewards and other behavioural strategies to encourage adherence to sleep hygiene recommendations.

  4. Simplified cognitive strategies: use of concrete language, metaphors and visual aids to simplify cognitive concepts.

  5. Tailored relaxation techniques: relaxation methods adapted to reduce complexity and accommodate individual preferences.

Interventions above may either be used singularly or in combination. CBT interventions for young children can be categorised into three delivery models: child-focused, parent-child collaborative and parent-only approaches.16

  1. Child-focused CBT involves direct one-on-one therapy with children, where interventions are exclusively tailored to the child with little to no parental participation.

  2. Parent–child collaborative CBT combines face-to-face sessions for children with joint or separate sessions for parents/caregivers/family members. These sessions typically include parental psychoeducation or training to equip caregivers as co-therapists.

  3. Parent-only CBT focuses solely on engaging parents through direct counselling, providing them with support and strategies to implement CBT techniques in their children’s daily routines.

Exclusion criteria

Interventions that do not specifically target sleep disorders or use pharmacological treatments as the primary intervention.

Types of controls

Controlled interventions will include placebo groups, no treatment or other conventional treatments.

Types of outcome measures

Primary outcomes: any outcome related to SOL and total sleep time.

Secondary outcomes: supplementary measures such as ISI, PSQI, wake after sleep onset, daytime sleepiness, negative daytime behaviour, emotional dysregulation, sleep–wake diary, Paediatric Anxiety Rating Scale and CSHQ would be taken into account as well.

Information sources and search strategy

Search strategy

We will thoroughly search for all studies that have been published from the inception of each database to 1 May 2025. Our search will include databases such as Web of Science, PubMed, Ovid, Embase, Cochrane Library, China National Knowledge Infrastructure, Wanfang, VIP and Sinomed. Medical Subject Headings such as ‘Autism Spectrum Disorder’, ‘Cognitive Behavioral Therapy’ and free words (eg, autism, Autistic Spectrum, Cognitive Behavior Therapy, Cognitive Behavior Therapies, sleep) will be used for the search strategy. The detailed search strategy employed for Cochrane Library is shown in table 1. We will impose no restrictions based on language, demographic characteristics or geographical location. The selection process will be presented in a PRISMA flow diagram (figure 1).

Table 1. Search strategy for Cochrane library.
ID Search Hits
#1 ('Behavioral Therapies, Cognitive' OR 'Behavioral Therapy, Cognitive' OR 'Cognitive Behavioral Therapies' OR 'Therapies, Cognitive Behavioral' OR 'Therapy, Cognitive Behavioral' OR 'Cognition Therapy' OR 'Cognition Therapies' OR 'Therapies, Cognition' OR 'Therapy, Cognitive Behavior' OR 'Behavior Therapies, Cognitive' OR 'Cognitive Behavior Therapies' OR 'Therapies, Cognitive Behavior' OR 'Therapy, Cognition' OR 'Behavior Therapy, Cognitive' OR 'Cognitive Behavior Therapy' OR 'Cognitive Psychotherapy' OR 'Cognitive Psychotherapies' OR 'Psychotherapies, Cognitive' OR 'Psychotherapy, Cognitive' OR 'Therapy, Cognitive' OR 'Cognitive Therapies' OR 'Therapies, Cognitive' OR 'Cognitive Behaviour Therapy' OR 'Behaviour Therapies, Cognitive' OR 'Behaviour Therapy, Cognitive' OR 'Cognitive Behaviour Therapies' OR 'Therapies, Cognitive Behaviour' OR 'Therapy, Cognitive Behaviour' OR 'Cognitive Therapy'):ti,ab,kw 60 054
#2 ('autism spectrum disorder' OR 'autism, early infantile' OR 'autism, infantile' OR 'autistic child' OR 'autistic children' OR 'autistic disorder' OR 'autistic spectrum disorder' OR 'child development disorders, pervasive' OR 'childhood autism' OR 'classical autism' OR 'early infantile autism' OR 'infantile autism' OR 'infantile autism, early' OR 'Kanner syndrome' OR 'PDD (pervasive developmental disorder)' OR 'pervasive child development disorders' OR 'pervasive developmental disorder' OR 'pervasive developmental disorders' OR 'typical autism' OR 'autism'):ti,ab,kw 6084
#3 MeSH descriptor: (Cognitive Behavioral Therapy) explode all trees 14 685
#4 #1 OR #3 62 111
#5 MeSH descriptor: (Autism Spectrum Disorder) explode all trees 2818
#6 #2 OR #5 6099
#7 #4 AND #6 782
#8 ('randamized controlled trial*' OR 'Randomized Controlled Trial*' OR 'RCT'):ti,ab,kw 844 100
#9 #7 AND #8 512
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Figure 1. Flow diagram showing the selection process of articles. Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 flow diagram for new systematic reviews which included searches of databases and registers only.

Figure 1

Open in a new tab

Data collection and management

Two independent reviewers (QYZ and YZ) will screen titles and abstracts, followed by full-text evaluation of potentially eligible studies. Data will be extracted using a standardised form created in Excel, in which study details include author, year, country, publication year and language; participant information includes sample size, gender, average age, diagnosis and sleep problems; intervention details include frequency, duration, follow-up periods; sleep outcome measures include subjective (eg, self-reported) and objective (eg, actigraphy) measures; and methodological aspects include study design, randomisation, blinding and allocation. Any discrepancies will be resolved through discussion or consultation with a third reviewer (YX W). Should the data prove to be incomplete or ambiguous, efforts will be made to contact the corresponding authors to solicit further information.

Risk of bias assessment

The Cochrane Risk of Bias Tool V.2 (RoB2)44 45 for randomised trials, Risk Of Bias In Non-randomised Studies—of Interventions (ROBINS-I) for non-randomised trials46 47 and the Newcastle–Ottawa Scale for observational studies48 49 will be used to evaluate the bias level in the studies included:

  1. For RoB2, the tool addresses five domains with different questions:

    1. Bias arising from the randomisation process.

    2. Bias due to deviations from intended interventions.

    3. Bias due to missing outcome data.

    4. Bias in measurement of the outcome.

    5. Bias in selection of the reported result.

  2. For ROBINS-I, the tool is formed by seven key areas:

    1. Bias due to confounding.

    2. Bias in selection of participants into the study.

    3. Bias in classification of interventions.

    4. Bias due to deviations from intended interventions.

    5. Bias due to missing data.

    6. Bias in measurement of outcomes.

    7. Bias in selection of the reported result.

  3. For NOS, the tool is focused on three main areas:

    1. Selection of study groups.

    2. Comparability of groups.

    3. Assessment of outcome.

Bias assessments for each study were recorded in Review Manager 5.3 for summarisation and visualisation in a risk of bias table and graph. Two reviewers (QYZ and YZ) will independently assess the risk of bias, with discrepancies resolved by a third reviewer (YX W).

Statistical analysis

The meta-analysis will be conducted using Stata Statistical Software, V.18 (Stata 18). Continuous variables will be analysed using mean difference or standardised mean difference (SMD) with 95% CIs, while dichotomous data will be analysed using risk ratios with 95% CIs. In the event that outcomes are evaluated using identical assessment tools or scales, the weighted mean difference will be employed; in contrast, the SMD will be used when assessment tools or scales are different.50 Statistical significance will be set at a significance level of p value less than 0.05 (p<0.05).47

Assessment of heterogeneity

Heterogeneity will be evaluated using the Cochran’s Q test and the I² statistic, which quantify the proportion of variability across studies attributable to heterogeneity rather than random error.51,53 The I² statistic ranges from 0% to 100%, with values exceeding 50% (I²＞50%), indicating a significant degree of heterogeneity, and values below or equal to 50% (I²≤50%), indicating a non-significant level of heterogeneity. The reviewers will evaluate the presence of heterogeneity within the data to determine whether to conduct a meta-analysis and choose a suitable model according to the results. If no substantial heterogeneity is found (I²≤50%), the fixed-effect model will be used; otherwise, a random-effects model will be applied when the statistical heterogeneity is significant (I²≥50%).47

To ensure the validity of quantitative synthesis, data will be considered suitable if they exhibit homogeneity in study design and outcome measures, sufficient data quality and quantity for robust analysis and direct relevance to the research question. Transparent reporting in accordance with established guidelines (eg, Strengthening the Reporting of Observational Studies in Epidemiology, 48PRISMA and Consolidated Standards of Reporting Trials)49 is also required if necessary. On meeting these criteria, we will employ a fixed-effect model for low heterogeneity (I² ≤ 50%) or a random-effects model for significant heterogeneity (I² > 50%), as detailed earlier.

If the I² statistic exceeds 50% (I² ≥ 50%), suggesting significant heterogeneity among the studies, a systematic investigation will be undertaken to identify the potential sources of this heterogeneity, mainly focusing on three aspects:

  1. Statistical heterogeneity: variations in numerical results across studies.

  2. Methodological heterogeneity: differences in study design, implementation and analysis methods.

  3. Clinical heterogeneity: variations in patient characteristics, interventions and outcomes.

To address these sources of heterogeneity, the following approaches will be employed:

  1. Narrative analyses: when quantitative synthesis through meta-analysis is not feasible due to significant heterogeneity or insufficient data, we will conduct detailed narrative analyses to qualitatively summarise and interpret the study findings.

  2. Meta-regression54: if sufficient data are available, we will perform meta-regression to statistically explore the impact of potential moderators (eg, study design, patient demographics, intervention specifics) on the observed heterogeneity.

These methods will help us provide a comprehensive understanding of the observed heterogeneity and offer insights into the underlying causes of variations in the study results.

Subgroup analysis

Subgroup analyses will be conducted to explore potential sources of heterogeneity if sufficient data are available, focusing on factors such as sample size, participant demographics, treatment frequency and duration, and duration of follow-up. If no clear sources of heterogeneity are identified, detailed descriptions of the variables and results will be provided, with the conclusion that no significant factors influencing the heterogeneity were detected.

Sensitivity analyses and publication bias

Sensitivity analyses will be performed to assess the robustness of the findings by excluding studies with high risk of bias. This method allows for a systematic evaluation of each study’s impact on the observed heterogeneity. To evaluate publication bias, funnel plots and Egger’s regression tests will be employed.55,57

Quality of evidence

The evaluation of the evidence’s certainty will be conducted following the Grading of Recommendations Assessment, Development and Evaluation framework, which entails an examination of eight dimensions of study limitations: risk of bias, imprecision, inconsistency, indirectness and publication bias, as well as the magnitude of effects, dose–response relationships and the impact of residual confounding and bias. Based on these criteria, the quality of evidence will be classified into one of four categories: ‘very low’, ‘low’, ‘moderate’ or ‘high’.58 59 Two reviewers will independently evaluate the certainty of the evidence, and in the event of any disagreements, a third reviewer will be consulted to resolve them. Explanations will be provided and the rationale behind each assessment will be documented in our report for every outcome.

Ethics and dissemination

Given that the dataset for this investigation is derived from publicly accessible databases there is no direct interaction with patients, ethical approval is not required.

Discussion

This protocol outlines the design and methodology for a systematic review and meta-analysis that aims to synthesise existing evidence on the efficacy of CBT in improving sleep quality among individuals with ASD. To our knowledge, this will be the first systematic review to comprehensively address this topic, bridging a critical gap in understanding non-pharmacological interventions for sleep disturbances in ASD. By adhering to PRISMA-P guidelines and PROSPERO registration standards, this protocol ensures methodological rigour, transparency and reproducibility, which are essential for generating reliable evidence to inform clinical practice and future research.

Anticipated contributions and novelty

This review will consolidate fragmented evidence; evaluate effect sizes across diverse CBT adaptations and multimodal combinations; and explore heterogeneity sources such as intervention duration, sensory accommodations and outcome measurement tools (actigraphy vs self-report). Second, by including non-English studies, this review will enhance cross-cultural generalisability—a critical step given the global prevalence of ASD and sleep comorbidities. Third, the planned subgroup analyses (eg, age, intervention type) and sensitivity assessments (eg, excluding high-bias studies) aim to clarify which CBT components are most effective for specific ASD subgroups, addressing calls for personalised interventions.

Acknowledgements

The authors would like to express their gratitude to all group members for their support and assistance.

Footnotes

Funding: This work was supported by the Shanghai Key Laboratory of Health Identification and Assessment (21DZ2271000) and Shanghai Program Innovation and Training Undergraduate on Entrepreneurship (SUTPIE) (No: 202410268202).

Prepublication history for this paper is available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2025-101084).

Patient consent for publication: Not applicable.

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

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