CLINICAL TRIAL

The Talk Parenting Skill for Alexa for Parasomnias

Recruiting · Any Age · All Sexes · Eugene, OR

This study is evaluating whether a new technology can help improve parenting skills.

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About the trial for Parasomnias

Eligible Conditions
Stress (Psychology) · Parasomnias · Self Efficacy · Adjustment, Emotional · Dyssomnias · Children Behavior · Parenting Practices · Sleep disorders and disturbances · Relation, Parent-Child

Treatment Groups

This trial involves 2 different treatments. The Talk Parenting Skill For Alexa is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
The Talk Parenting Skill for Alexa
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Child 3-5 years old who lives with the parent at least half time
1. Families of target-age children with a developmental disability severe enough that the child cannot speak or follow simple directions will be excluded; their needs are beyond the scope of Talk Parenting
Referred by a participating agency
The primary parent in the home (typically the mother but not always)
Has access to email. Access to high-speed internet at home is desired but not required. The participating agencies all serve families who are low-income and/or experiencing economic hardship, stressful family relationships, children's behavior problems, parental adjustment issues (mental health, substance use), or household instability; thus referred families will be experiencing one or more of these risk factors for a high-risk family environment.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Month 9
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Month 9.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether The Talk Parenting Skill for Alexa will improve 5 primary outcomes and 3 secondary outcomes in patients with Parasomnias. Measurement will happen over the course of Enrollment, 6 weeks (at treatment completion).

Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ)
ENROLLMENT, 6 WEEKS (AT TREATMENT COMPLETION)
Measure change in Children's bedtime/sleep problems; the Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ), a 23-item version of the widely used CSHQ. The SF-CSHQ shows good validity against the original CSHQ, external validity, internal reliability, and sensitivity to change.
Child Adjustment & Parent Self-Efficacy Scale (CAPES)
ENROLLMENT, 6 WEEKS (AT TREATMENT COMPLETION)
Measure change using The Child Adjustment & Parent Efficacy Scale (CAPES) in children's behaviors and emotional adjustment. The Behavior Problems subscale consists of 16 problematic and 8 reverse-coded positive behaviors; the Emotional Maladjustment subscale has 3 items. The CAPES is highly correlated with the Eyberg Child Behavior Inventory (ECBI), a common measure for children's behavior problems, but the CAPES has the added advantage that it includes positive behavior items and emotional maladjustment, and is less burdensome for parents to complete. The CAPES will also be used to measure parent's self-efficacy; parents rate their confidence that they can successfully deal with each of the 19 negative behaviors/emotions on the CAPES. The CAPES will be adapted to include additional items about the child's cooperation before bed at bedtime.
Parenting & Family Adjustment scales (PAFAS)
ENROLLMENT, 6 WEEKS (AT TREATMENT COMPLETION)
Measure change using the Parenting & Family Adjustment Scales; the PAFAS is used to measure change in parenting practices, parents' stress, and the parent-child relationship. The 30 items on the PAFAS sort into 7 subscales with good internal consistency and construct validity: Parental consistency, Coercive parenting, Positive encouragement, Parent-child relationship, Parental adjustment/stress, Family relationships, and Parental teamwork with partner. The PAFAS will be adapted to include additional items about the presence of a bedtime routine and parents' satisfaction with how that routine is going.
Program Satisfaction
AT 6 WEEKS (TREATMENT COMPLETION)
Parent Satisfaction will measure with 14 items at 6 weeks (at treatment completion), asking the extent to which primary parents found the Talk Parenting skill helpful, acceptable, and suited to their needs. We will also ask about any problems experienced, frustrations, behaviors or relationships made worse, or points of dissatisfaction.
System Usability scale (SUS)
AT 6 WEEKS (TREATMENT COMPLETION)
Skill usability will be measured with the System Usability Scale (SUS), a commonly used 10-item scale that measures subjective perceptions of usability.
Families' usage of the TP skill
AT 6 WEEKS (TREATMENT COMPLETION)
Families' usage of the TP skill will measure through usage metrics and transcripts collected on the back-end database, including activation of the skill; which scripts are accessed and by whom; frequency, timing, and duration of engagements; elapsed time to accomplish the bedtime routine; and points of difficulty or failure.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can parasomnias be cured?

Current research has not shown that a cure exists for parasomnias. The most likely answer is that these symptoms cannot be avoided but can be controlled.

Anonymous Patient Answer

What causes parasomnias?

A number of different causes have been proposed. For example, the nocturnal frontal-like sleep pattern might be caused by genetic deficiencies in the dopaminergic neurotransmission system. Other causes include drug use/exposure, sleep deprivation, or hypoxia. Although our findings do not allow the identification of a single cause for parasomnias, they are useful for identifying different treatment approaches for each individual patient. The pathophysiology of sleep disorders is best understood by investigating one at a time and from a general perspective.

Anonymous Patient Answer

How many people get parasomnias a year in the United States?

More than 60 million American adults are affected by somnolence disorders every year. Approximately 50% of adults sleep less than 7 hours a night. Somnolence, a major health issue in America, has the potential to affect individuals of all age groups, including the elderly. Thus, these data have large community implications in future policy development.

Anonymous Patient Answer

What are the signs of parasomnias?

Parasympathetic signs of parasomnias include dilated pupils; sweating during the night; increased salivation; heart rate increases during the night or under stress; sweating or blushing in response to cold or when the face is exposed to wind; or sweating while in bed. Parasympathetic signs of parasomnias that occur during the day include daytime sleepiness and decreased intellectual performance.

Anonymous Patient Answer

What is parasomnias?

In older persons, parasomnias can be associated with problems with self-care, mobility and cognitive functioning and therefore, are a risk factor for both incident and chronic geriatric syndromes. Older persons have increased morbidity and mortality compared with age-matched, non-geriatric outpatient populations.

Anonymous Patient Answer

What are common treatments for parasomnias?

There seems to be wide consensus regarding the treatment of parasomnias despite a need for more rigorous research. All but one (mild sleep paralysis) can be treated using the standard clinical evaluation, including education about possible triggers, and cognitive behavioral interventions for the most severe cases. Treatment of sleep paralysis usually requires the use of an antinoatropaic medication before the cognitive-behavioral treatment begins.

Anonymous Patient Answer

What is the average age someone gets parasomnias?

The median age of parasomniation and other sleep disorders was 42, substantially higher than the overall age of the population. Although there was also a significant difference between genders, the difference was only 5.6 years old, a small difference that may be accounted for by the higher female prevalence of sleep sleep disorders. The high prevalence of this sleep disorder in a general population of young adult Americans has implications for future preventive and pharmacologic interventions.

Anonymous Patient Answer

Who should consider clinical trials for parasomnias?

Clinical trial results should be reported in a reliable and consistent manner. The inclusion criteria for clinical trial eligibility should be defined and reported, as should the details and recommendations regarding study design and data collection for prospective studies.

Anonymous Patient Answer

What does the talk parenting skill for alexa usually treat?

Parenting skills were significantly related to children's treatment outcomes for sleep in this study, supporting the current recommendation to use parent training for children with sleep problems.

Anonymous Patient Answer

Does the talk parenting skill for alexa improve quality of life for those with parasomnias?

The present study did not show significant improvements in the quality of life and well-being of caregivers. In addition, no improvement was seen on the patient's side in terms of quality of life and well-being. Further prospective studies are needed to examine the possible impact of PLSs on caregiver mental and physical health.

Anonymous Patient Answer

Has the talk parenting skill for alexa proven to be more effective than a placebo?

The result of PARASOMIA indicated that alexa-t treatment can increase the parenting skill of caregivers that had previously had no training, therefore [to provide alexa-t to the parents of toddlers with cvs and/or to the parents with cvs-diagnose for their parenting skills at the [1st 6 months of life ] and/or for parents with cvs-diagnose-to strengthen parenting skill and to promote the parent-child relationship], it was more effective and lasted longer than [a placebo] to [increase the parenting skill].

Anonymous Patient Answer

What is the primary cause of parasomnias?

Abnormal sleep-wake schedules were present in about half the children, who were mainly free of comorbidity. Abnormal sleep schedules could be the main cause of parasomnias in this paediatric population.

Anonymous Patient Answer
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