Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 4 sessions of behavioral therapy for sleep problems followed by 4 bimonthly booster sessions. Children and their families will be randomly assigned to one of three conditions: cognitive behavioral therapy (in-person), cognitive behavioral therapy (remote), or behavioral therapy (remote). Arousal will be measured through heart-rate variability. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline (weeks 1-2 before starting the treatment), post-treatment (weeks 6-8 from baseline), 6-month follow-up, and 12-month follow-up.
Children with autism often have difficulties falling and staying asleep at night. Those sleep difficulties can contribute to daytime problems with irritability, learning, and behavior. Parents are often stressed about their child's sleep difficulties and as a result, their sleep can suffer as well. Treatment that focuses on establishing behaviors and routines that help reduce arousal and support good sleep are helpful for improving the sleep of children without autism, but have not yet been tested in children with autism. Previous studies have indicated that distance can make it difficult for families to participate in treatment. As such, we will conduct treatment remotely for two of treatment arms. Having remote versions of the treatment can expand the number of children and families that are able to receive these promising treatments. This may be particularly important for children with ASD living in rural and underserved areas as well as those in military families that may not have access to a healthcare provider with training in behavioral sleep treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
7 modules administered in-person 1. Sleep Hygiene \& Sleep Prescription 2. Bedtime Routine \& Parent Management 3. Cue Control \& Parent Management 4. Co-Sleeping \& Parents Fading out of Room 5. Circadian Education, Morning Routine, \& Relaxation 6. Cognitive Therapy Basics 7. Nighttime Fears, Anxiety, \& Nightmares
7 modules administered over telehealth/videoconferencing 1. Sleep Hygiene \& Sleep Prescription 2. Bedtime Routine \& Parent Management 3. Cue Control \& Parent Management 4. Co-Sleeping \& Parents Fading out of Room 5. Circadian Education, Morning Routine, \& Relaxation 6. Cognitive Therapy Basics 7. Nighttime Fears, Anxiety, \& Nightmares
7 modules administered over telehealth/videoconferencing 1. Sleep Education 2. Sleep Architecture \& Parasomnias 3. Physical Activity \& Sleep 4. Nutrition, My Plate, \& Breathing during Sleep 5. Stress, Sleep, Dreams, \& Nightmares Connections 6. Mood, Self-Esteem, \& Sleep 7. Light \& Dark Cycle
Thompson Center for Autism and Neurodevelopmental Disorders
Columbia, Missouri, United States
RECRUITINGBaseline Average Objective Sleep Efficiency for the child
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time frame: 24/7 during each 2 week assessment at Baseline
Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time frame: 24/7 during each 2 week assessment immediately after the intervention
Change in Average Objective Sleep Efficiency for the child from baseline to 6 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time frame: 24/7 during each 2 week assessment at 6 month follow up
Change in Average Objective Sleep Efficiency for the child from baseline to 12 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time frame: 24/7 during each 2 week assessment at 12 month follow up
Baseline Average Bed/Waketime Variability for the child
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Time frame: 24/7 during each 2 week assessment at Baseline
Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Time frame: 24/7 during each 2 week assessment immediately after the intervention
Change in Average Bed/Waketime Variability for the child from baseline to 6 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Time frame: 24/7 during each 2 week assessment at 6 month follow up
Change in Average Bed/Waketime Variability for the child from baseline to 12 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity and daily diary report
Time frame: 24/7 during each 2 week assessment at 12 month follow up
Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child
Child arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at Baseline (in clinic)
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to immediately after the intervention
Child arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest immediately after the intervention (in clinic)
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 6 months
Child arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 6 month follow up (in clinic)
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the child from baseline to 12 months
Child arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 12 month follow up (in clinic)
Baseline Average Objective Total Sleep Time for the parent
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time frame: 24/7 during each 2 week assessment at Baseline
Change in Average Objective Total Sleep Time for the parent from baseline to immediately after the intervention
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time frame: 24/7 during each 2 week assessment immediately after the intervention
Change in Average Objective Total Sleep Time for the parent from baseline to 6 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time frame: 24/7 during each 2 week assessment at 6 month follow up
Change in Average Objective Total Sleep Time for the parent from baseline to 12 months
Actigraph (Actiwatch 2â, Philips Respironics) measures light and gross motor activity
Time frame: 24/7 during each 2 week assessment at 12 month follow up
Baseline Aberrant Behavior Checklist (ABC) for the child
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Time frame: Baseline
Aberrant Behavior Checklist (ABC) for the child immediately after the intervention
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Time frame: Immediately after the intervention
Aberrant Behavior Checklist (ABC) for the child at 6 months
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Time frame: At 6 month follow up
Aberrant Behavior Checklist (ABC) for the child at 12 months
Aberrant Behavior Checklist (ABC) is a 58-item parent-report measure of daytime problem behaviors that is psychometrically strong and sensitive to treatment effects in children with ASD. It will be filled out by the parent in reference to the child.
Time frame: At 12 month follow up
Baseline Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+)
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time frame: Baseline
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) immediately after the intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time frame: Immediately after the intervention
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 6 months
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time frame: At 6 month follow up
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) for a child (ages 8+) at 12 months
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time frame: At 12 month follow up
Baseline Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7)
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time frame: Baseline
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) immediately after the intervention
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time frame: Immediately after the intervention
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 6 months
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time frame: At 6 month follow up
Conners' Kiddie Continuous Performance Test (K-CPT) for a child (ages 6-7) at 12 months
Conners' Continuous Performance Test - 3rd Edition (CCPT-3) is a computerized measure of inattentiveness, impulsivity, sustained attention, and vigilance for aged 8 and above. Conners' Kiddie Continuous Performance Test (K-CPT) will be used for children aged 6 and 7 which provides a comparable measure of the four domains of attention. To account for two different measures in analyses, standardized scores will be used.
Time frame: At 12 month follow up
Baseline Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Time frame: Baseline
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child immediately after the intervention
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Time frame: Immediately after the intervention
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 6 months
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Time frame: At 6 month follow up
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) for the child at 12 months
Behavior Rating Inventory of Executive Function - 2nd Edition (BRIEF-2) is a 86-item parent-report measure of day-to-day executive functioning and impairment. It will be filled out by the parent in reference to the child.
Time frame: At 12 month follow up
Baseline Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Time frame: Baseline
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child immediately after the intervention
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Time frame: Immediately after the intervention
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 6 months
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Time frame: At 6 month follow up
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) for the child at 12 months
Child and Adolescent Symptom Inventory - 4th Edition Revised (CASI-4R) includes 20 parent-reported items and is an appropriate outcome tool for children with ASD. It will be filled out by the parent in reference to the child.
Time frame: At 12 month follow up
Baseline Child Quality of Life: PedsQL Child Form for the child
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Time frame: Baseline
Child Quality of Life: PedsQL Child Form for the child immediately after the intervention
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Time frame: Immediately after the intervention
Child Quality of Life: PedsQL Child Form for the child at 6 months
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Time frame: At 6 month follow up
Child Quality of Life: PedsQL Child Form for the child at 12 months
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the child in reference to the child.
Time frame: At 12 month follow up
Baseline Child Quality of Life: PedsQL Parent Form for the child
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Time frame: Baseline
Child Quality of Life: PedsQL Parent Form for the child immediately after the intervention
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Time frame: Immediately after the intervention
Child Quality of Life: PedsQL Parent Form for the child at 6 months
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Time frame: At 6 month follow up
Child Quality of Life: PedsQL Parent Form for the child at 12 months
Child Quality of Life: PedsQL is a 23-item scale measuring children's QOL. It has excellent internal consistency, clinical validity, and factor-analytic support. It will be filled out by the parent in reference to the child.
Time frame: At 12 month follow up
Baseline Average Subjective Sleep Onset Latency for the child
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Time frame: Each morning for 2 weeks at Baseline
Change in Average Subjective Sleep Onset Latency for the child from baseline to immediately after the intervention
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Time frame: Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Sleep Onset Latency for the child from baseline to 6 months
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Time frame: Each morning for 2 weeks at 6 month follow up
Change in Average Subjective Sleep Onset Latency for the child from baseline to 12 months
Diary-reported amount of time from lights out to beginning of sleep filled out by the child (with parent help) regarding the child's sleep
Time frame: Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Total Wake Time for the child
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Time frame: Each morning for 2 weeks at Baseline
Change in Average Subjective Total Wake Time for the child from baseline to immediately after the intervention
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Time frame: Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Total Wake Time for the child from baseline to 6 months
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Time frame: Each morning for 2 weeks at 6 month follow up
Change in Average Subjective Total Wake Time for the child from baseline to 12 months
Diary-reported time awake from lights out until out of bed filled out by the child (with a parent's help) regarding the child's sleep
Time frame: Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Total Sleep Time for the child
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Time frame: Each morning for 2 weeks at Baseline
Change in Average Subjective Total Sleep Time for the child from baseline to immediately after the intervention
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Time frame: Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Total Sleep Time for the child from baseline to 6 months
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Time frame: Each morning for 2 weeks at 6 month follow up
Change in Average Subjective Total Sleep Time for the child from baseline to 12 months
Diary-reported total sleep time filled out by the child (with help of a parent) regarding the child's sleep
Time frame: Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Sleep Efficiency for the child
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Time frame: Each morning for 2 weeks at Baseline
Change in Average Subjective Sleep Efficiency for the child from baseline to immediately after the intervention
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Time frame: Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Sleep Efficiency for the child from baseline to 6 months
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Time frame: Each morning for 2 weeks at 6 month follow up
Change in Average Subjective Sleep Efficiency for the child from baseline to 12 months
Diary-reported total sleep time/time in bed x 100% filled out by the child (with help from a parent) regarding the child's sleep
Time frame: Each morning for 2 weeks at 12 month follow up
Baseline Average LF/HF ratio for the child
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at Baseline (in clinic)
Change in Average LF/HF ratio for the child from baseline to immediately after the intervention
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest immediately after the intervention (in clinic)
Change in Average LF/HF ratio for the child from baseline to 6 months
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 6 month follow up (in clinic)
Change in Average LF/HF ratio for the child from baseline to 12 months
An index of the child's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 12 month follow up (in clinic)
Baseline Average pNN50 (% of N-N intervals > 50 ms) for the child
Child arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at Baseline (in clinic)
Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to immediately after the intervention
Child arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest immediately after the intervention (in clinic)
Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 6 months
Child arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 6 month follow up (in clinic)
Change in Average pNN50 (% of N-N intervals > 50 ms) for the child from baseline to 12 months
Child arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 12 month follow up (in clinic)
Baseline Average LF/HF ratio for the parent
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at Baseline (in clinic)
Change in Average LF/HF ratio for the parent from baseline to immediately after the intervention
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest immediately after the intervention (in clinic)
Change in Average LF/HF ratio for the parent from baseline to 6 months
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 6 month follow up (in clinic)
Change in Average LF/HF ratio for the parent from baseline to 12 months
An index of the parent's autonomic nervous system regulation measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 12 month follow up (in clinic)
Baseline Average pNN50 (% of N-N intervals > 50 ms) for the parent
Parent arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at Baseline (in clinic)
Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to immediately after the intervention
Parent arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest immediately after the intervention (in clinic)
Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 6 months
Parent arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 6 month follow up (in clinic)
Change in Average pNN50 (% of N-N intervals > 50 ms) for the parent from baseline to 12 months
Parent arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 12 month follow up (in clinic)
Baseline Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent
Parent arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at Baseline (in clinic)
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to immediately after the intervention
Parent arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest immediately after the intervention (in clinic)
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 6 months
Parent arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 6 month follow up (in clinic)
Change in Average RMSDNN (root mean squared st. dev. of N-N intervals) for the parent from baseline to 12 months
Parent arousal measured by Holter Monitors, 8 min ECG
Time frame: 8 minute protocol during rest at 12 month follow up (in clinic)
Baseline State-Trait Anxiety Inventory (STAI-Y1) for the parent
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale \[1 (not at all) to 4 (very much so)\]. This will be filled out by the parents regarding the parents.
Time frame: Baseline
State-Trait Anxiety Inventory (STAI-Y1) for the parent immediately after the intervention
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale \[1 (not at all) to 4 (very much so)\]. This will be filled out by the parents regarding the parents.
Time frame: Immediately after the intervention
State-Trait Anxiety Inventory (STAI-Y1) for the parent at 6 months
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale \[1 (not at all) to 4 (very much so)\]. This will be filled out by the parents regarding the parents.
Time frame: At 6 month follow up
State-Trait Anxiety Inventory (STAI-Y1) for the parent at 12 months
State-Trait Anxiety Inventory (STAI-Y1) includes 20 self-descriptive statements rated according to how the parent generally feels on a 4-point scale \[1 (not at all) to 4 (very much so)\]. This will be filled out by the parents regarding the parents.
Time frame: At 12 month follow up
Baseline Beck Depression Inventory (BDI-II) for the parent
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Time frame: Baseline
Beck Depression Inventory (BDI-II) for the parent immediately after the intervention
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Time frame: Immediately after the intervention
Beck Depression Inventory (BDI-II) for the parent at 6 months
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Time frame: At 6 month follow up
Beck Depression Inventory (BDI-II) for the parent at 12 months
Beck Depression Inventory (BDI-II) includes 21 items that measures the severity of depressive symptomatology on a 4-point scale (0-absence of symptoms; 3-severe). This will be filled out by the parents regarding the parents.
Time frame: At 12 month follow up
Baseline Fatigue Severity Scale for the parent
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Time frame: Baseline
Fatigue Severity Scale for the parent immediately after the intervention
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Time frame: Immediately after the intervention
Fatigue Severity Scale for the parent at 6 months
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Time frame: At 6 month follow up
Fatigue Severity Scale for the parent at 12 months
Fatigue Severity Scale includes 9 items on the severity of fatigue and how fatigue interferes with activities on a 7-point scale (1-strongly disagree; 7-strongly agree). This will be filled out by the parents regarding the parents.
Time frame: At 12 month follow up
Baseline Daily Fatigue for the parent
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Time frame: Baseline
Daily Fatigue for the parent immediately after the intervention
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Time frame: Immediately after the intervention
Daily Fatigue for the parent at 6 months
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Time frame: At 6 month follow up
Daily Fatigue for the parent at 12 months
Daily Fatigue rated on electronic diaries (0-none;100-most intense imaginable). This will be filled out by the parents regarding the parents.
Time frame: At 12 month follow up
Baseline Caregiver Strain Index (CSI) for the parent
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Time frame: Baseline
Caregiver Strain Index (CSI) for the parent immediately after the intervention
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Time frame: Immediately after the intervention
Caregiver Strain Index (CSI) for the parent at 6 months
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Time frame: At 6 month follow up
Caregiver Strain Index (CSI) for the parent at 12 months
Caregiver Strain Index (CSI) includes 12 items on caregiving impact on well-being. This will be filled out by the parents regarding the parents.
Time frame: At 12 month follow up
Baseline Average Subjective Sleep Onset Latency for the parent
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Time frame: Each morning for 2 weeks at Baseline
Change in Average Subjective Sleep Onset Latency for the parent from baseline to immediately after the intervention
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Time frame: Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Sleep Onset Latency for the parent from baseline to 6 months
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Time frame: Each morning for 2 weeks at 6 month follow up
Change in Average Subjective Sleep Onset Latency for the parent from baseline to 12 months
Diary-reported amount of time from lights out to beginning of sleep filled out by the parent regarding parent sleep
Time frame: Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Total Wake Time for the parent
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks at Baseline
Change in Average Subjective Total Wake Time for the parent from baseline to immediately after the intervention
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Total Wake Time for the parent from baseline to 6 months
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks at 6 month follow up
Change in Average Subjective Total Wake Time for the parent from baseline to 12 months
Diary-reported time awake from lights out until out of bed filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Total Sleep Time for the parent
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks at Baseline
Change in Average Subjective Total Sleep Time for the parent from baseline to immediately after the intervention
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Total Sleep Time for the parent from baseline to 6 months
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks at 6 month follow up
Change in Average Subjective Total Sleep Time for the parent from baseline to 12 months
Diary-reported total sleep time filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks at 12 month follow up
Baseline Average Subjective Sleep Efficiency for the parent
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks at Baseline
Change in Average Subjective Sleep Efficiency for the parent from baseline to immediately after the intervention
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks immediately after the intervention
Change in Average Subjective Sleep Efficiency for the parent from baseline to 6 months
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks at 6 month follow up
Change in Average Subjective Sleep Efficiency for the parent from baseline to 12 months
Diary-reported total sleep time/time in bed x 100% filled out by the parent regarding the parent's sleep
Time frame: Each morning for 2 weeks at 12 month follow up