Trial · NCT04925258
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in parenting stress | : Time 1 prior to the beginning SPACE Program to ensure participants meet the inclusion criteria (upper 50th percentile on the PSI) and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx. 3 months after | The Parenting Stress Index - Short Form (PSI) is a 36-item self-report measure completed by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. Responses to each item in a sub-category are totaled to calculate three subcategory scores, which are summed to represent a total parenting stress score. Higher scores indicate higher levels of parenting stress. Normal scores fall within the 15th to 85th percentile, and scores above the 85th percentile represent clinically elevated levels of stress. |
| Secondary | Change in child mental health and behaviour | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2). | Child behaviour from pre-intervention to post-intervention: Strengths and Difficulties Questionnaire (SDQ). A 25-item instrument developed to detect psychosocial problems in children aged 3-16 years. A value is given to each selection of "not true," somewhat true," and "certainly true." It measures five factors: emotional problems, conduct problems, hyperactivity/inattention problems, peer problems, and prosocial behaviour. All subscales include five items and range from 0-10. A total score can be summed from the first four factors; the total score ranges from 0-40, with higher scores indicating greater difficulties. Scores on the fifth factor of prosocial behaviour range from 0-10, with a lower score on this scale being less favourable. |
| Secondary | Change in child behaviour | Time 1 prior to beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx. 3 months after Time 2). | The Parent Daily Report will be used to assess parent-reported child behaviors in past 24 hours. This scale assess child behaviour and degree of parental stress through 12-items. These items are reported on a 3-point Likert scale from "did not occur" (0) to "occurred and stressful" (2). Higher scores on an item indicate more negative child behaviours and more stressful experiences. |
| Secondary | Change in parent depressive symptoms | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2). | The Patient Health Questionnaire - 9 (PHQ-9) is a self-administered diagnostic instrument used to assess symptoms of major depressive disorder. The measure uses a 4-point Likert scale to assess the frequency of symptoms ranging from "not at all" to "nearly every day." A total score ranges from 0 to 27, with higher scores indicating greater depressive symptoms. This measure will be completed by participants weekly throughout the intervention. |
| Secondary | Change in parent anxiety symptoms | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2). | Generalized Anxiety Disorder - 7 item scale (GAD-7) is a brief self-report measure to screen for generalized anxiety disorder. Scores range from 0-21, with higher scores indicating more severe anxiety. |
| Secondary | Change in parent anger symptoms | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2). | The PROMIS Emotional Distress - Anger - Short-Form is a brief self-report measure used to assess the domain of anger. The items are measured on a 5-point Likert scale from "never" (1) to "always" (5). Total scores range from 5 to 25, with higher scores indicating more severe anger. |
| Secondary | Change in emotion-focused parenting practices | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2) | The Parenting Scale (PS) is a self-report measure of parenting style. The scale uses 30 items to assess various aspects of parenting/caregiving on a 7-point Likert scale. Scores are measured on a scale of 1-7 on each item, with 7 being less effective measures. The scale produces three subscale scores of Laxness (5-items), Overreactivity (5-items), and Verbosity (3-items), as well as a total score that includes all items. Scores are calculated by summing the items and dividing by the number of items to create a mean score; for example, the total score ranges from 1-7. Higher scores represent less effective parenting. |
| Secondary | Change in parenting practices | Time 1: prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx. 3 months after Time 2). | The Parenting Young Children (PARYC) scale is a self-report measure containing 21 questions designed to address parenting behaviors relevant to caring for young children. The scale includes three subscales: Supporting Positive Behavior, Setting Limits, and Proactive Parenting. Items are scored on a 5-point Likert scale from "never" (1) to "always" (5). Total scores can be calculated for each scale with higher scores indicating more positive parenting behaviors. |
| Secondary | Change in mindful parenting practices intervention | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2). | The Mindfulness in Parenting Questionnaire (MIPQ) is a 61-item self-report measure of parenting mindfully. Items are scored on a 5-point Likert scale from "never" to "almost always." Raw summed scores can be converted using the MIPQ conversion table to standardized Rasch scores with a mean of 100 and standard deviation of 15, with higher scores indicating more mindfulness in parenting practices. |
| Secondary | Changes in perceived parental/caregiver resilience from pre-intervention to post-intervention | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2). | Connor Davidson Resilience Scale - 2 item (CD-RISC) measures resilience and the ability to bounce back after a tragedy, trauma, or stressful event. The measure includes two items scored on a 5-point Likert scale. Total scores range from 0 to 8, with higher scores indicating greater resilience. |
| Secondary | Changes in parent/child screen time pre and post intervention | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2). | Screen Time Questionnaire is a self-reported measure of screen time before and during COVID-19. The scale was created for the current study and contains a combination of open-ended and Likert scale questions. No cumulative score is used; instead, items will be evaluated individually. Higher scores on individual Likert scales generally indicate higher screen time use. |
| Secondary | Changes in parental/caregiver spanking practices from pre to post intervention | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2). | Parental Spanking will be assessed using a single-item assessing the frequency of spanking on a child's bottom, restricted to the age 2-5 years due to mandatory reporting guidelines for child maltreatment. Higher scores indicate greater frequency. |
| Secondary | Changes in family resources measured from pre to post intervention | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2). | Financial Strain will be assessed using a single-item created for a previous study. The item assess strain of managing unexpected expenses. Likert scores are reverse coded with the final score indicating greater financial strain. |
| Secondary | Changes in recent stressful events from pre to post intervention | Time period: Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1), and Time 3 (approx.. 3 months after Time 2). | Recent Stressful Experiences (RSE) is a self-report measure of recent family stressors and coping. This scale was adapted for the current study and contains a combination of open-ended and Likert scale questions. No cumulative score is used; instead, items will be evaluated individually. Higher scores on individual Likert scales assessing stressors indicate more stressors; higher scores on individual Likert scales assessing coping indicate greater resilience. |
| Other | Change in child cognitive function | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1). | Child cognitive function will be assessed with behavioural regulation tasks. Specifically, children will participate in the child version of the Stroop task, in which they will be required to say the opposite in response to pictures of Day/Night images and Happy/Sad faces. |
| Other | Change in child cardiac flexibility | Time 1 prior to the beginning SPACE Program and at Time 2 once again after the program is complete (approx. 8 weeks after Time 1). | Cardiac flexibility will be measured with a downloadable app called "Heart Rate Plus" and heart rates for parent and child measured three and five times throughout baseline and post-intervention assessments, respectively. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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