Online Self-Guided Parents of Little Ones® - Child Version: Effects on Mindful Parenting and Parenting Stress
NCT07932522, Not applicable, Active not recruiting, University of Coimbra
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Online Self-Guided Parents of Little Ones® - Child Version: Effects on Mindful Parenting and Parenting Stress | ClinicalTrials.gov |
| NCT number | NCT07932522 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 214 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Coimbra | ClinicalTrials.gov |
| Conditions | Parenting Stress | ClinicalTrials.gov |
| Interventions | Parents of Little Ones - Child version® | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in Parental Stress From Baseline (week 0) to Post-Intervention (week 10) | Baseline (week 0) and Post-Intervention (up to week 10) | Parental stress will be assessed using the Parental Stress Scale (PSS), an 18-item self-report questionnaire that measures stress associated with the parenting role. Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 18 to 90, with higher scores indicating greater levels of parental stress. | ClinicalTrials.gov |
| Primary | Changes in Mindful Parenting From Baseline (week 0) to Post-Intervention (week 10) | Baseline (week 0) and Post-Intervention (up to week 10) | Mindful parenting will be measured using the Interpersonal Mindfulness in Parenting Scale (IM-P), a 29-item self-report questionnaire assessing mindful parenting across five dimensions: Listening with Full Attention, Emotional Awareness of the Child, Compassion for the Child, Self-Regulation in Parenting, and Nonjudgmental Acceptance of Parental Functioning. Items are rated on a five-point Likert scale ranging from 1 (never true) to 5 (always true). The total score ranges from 29 to 145, with higher scores indicating greater levels of mindful parenting. | ClinicalTrials.gov |
| Secondary | Changes in Parental Burnout From Baseline (week 0) to Post-Intervention (week 10) | Baseline (week 0) and Post-Intervention (week 10) | Parental burnout will be measured using the Parental Burnout Assessment, a 23-item self-report instrument comprising four dimensions: 1) Emotional Exhaustion, which captures an extreme sense of exhaustion associated with the parenting role; 2) Contrast, which reflects perceived discrepancies between current experiences of parenting and how parents felt in the past; 3) Feelings of Being Fed Up, which assesses a loss of enjoyment and growing aversion toward parenting and 4) Emotional Distancing, which refers to a tendency to withdraw emotionally from one's children while still fulfilling basic caregiving responsibilities. Items are rated on a seven-point scale ranging from 0 (never) to 6 (every day). The total score ranges from 0 to 138, with higher scores indicating greater levels of parental burnout. | ClinicalTrials.gov |
| Secondary | Changes in Anxiety and Depression Symptomatology From Baseline (week 0) to Post-Intervention (week 10) | Baseline (week 0) and Post-Intervention (week 10) | The Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms of anxiety and depression over the previous seven days. The HADS comprises 14 items divided into two seven-item subscales: Anxiety (HADS-A) and Depression (HADS-D). Items are rated on a four-point scale ranging from 0 to 3. Each subscale score ranges from 0 to 21, with higher scores indicating greater severity of anxiety or depressive symptoms, respectively. | ClinicalTrials.gov |
| Secondary | Changes in Attachment Anxiety and Avoidance From Baseline (week 0) to Post-Intervention (week 10) | Baseline (week 0) and Post-Intervention (week 10) | Attachment-related anxiety and avoidance will be assessed using the Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS), a nine-item self-report measure of attachment in close relationships. In this study, only global attachment will be assessed. Items are rated on a seven-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Two subscale scores are calculated by averaging the corresponding items, after reverse-scoring where appropriate. Both attachment-related anxiety and attachment-related avoidance scores range from 1 to 7, with higher scores indicating greater attachment insecurity in the respective dimension. | ClinicalTrials.gov |
| Secondary | Changes in Parental Satisfaction From Baseline (week 0) to Post-Intervention (week 10) | Baseline (week 0) and Post-Intervention (week 10) | Parental satisfaction will be assessed using the Kansas Parental Satisfaction Scale (KPSS), a three-item self-report measure designed to assess overall satisfaction with parenting. The scale assesses parents' satisfaction with their role as a parent, their child's behavior, and the quality of their relationship with their child. Items are rated on a seven-point Likert scale ranging from 1 (extremely dissatisfied) to 7 (extremely satisfied). The total score ranges from 3 to 21, with higher scores indicating greater parental satisfaction. | ClinicalTrials.gov |
| Secondary | Changes in Infant Social-Emotional and Behavioral Difficulties (BPSC) From Baseline (Week 0) to Post-Intervention (Week 10) | Baseline (week 0) and Post-Intervention (week 10) | Infant social-emotional and behavioral difficulties will be assessed using the Baby Pediatric Symptom Checklist (BPSC), a 12-item caregiver-reported screening measure administered to parents of children younger than 18 months. The BPSC comprises three four-item subscales: Inflexibility, Irritability, and Difficulty with Routines. Items are rated on a three-point scale ranging from 0 (not at all) to 2 (very much). Each subscale score ranges from 0 to 8, with higher scores indicating greater social-emotional and behavioral difficulties (a worse outcome). | ClinicalTrials.gov |
| Secondary | Changes in Preschool Children's Social-Emotional and Behavioral Difficulties (PPSC) From Baseline (Week 0) to Post-Intervention (Week 10) | Baseline (week 0) and Post-Intervention (week 10) | Preschool children's social-emotional and behavioral difficulties will be assessed using the Preschool Pediatric Symptom Checklist (PPSC), an 18-item caregiver-reported screening measure administered to parents of children aged 18 months to 5 years (up to 65 months). Items are rated on a three-point scale ranging from 0 (not at all) to 2 (very much). The total score ranges from 0 to 36, with higher scores indicating greater social-emotional and behavioral difficulties (a worse outcome). | ClinicalTrials.gov |
| Secondary | Changes in Mindfulness From Baseline (week 0) to Post-Intervention (week 10) | Baseline (week 0) and Post-Intervention (week 10) | Dispositional mindfulness will be assessed using the Mindful Attention Awareness Scale (MAAS), a 15-item self-report questionnaire measuring present-moment attention and awareness. Items are rated on a six-point Likert scale ranging from 1 (almost always) to 6 (almost never). The MAAS assesses a unidimensional construct reflecting an individual's tendency to attend to and remain aware of present-moment experiences. The overall score is calculated by averaging the 15 items and ranges from 1 to 6, with higher scores indicating greater levels of dispositional mindfulness. | ClinicalTrials.gov |
| Secondary | Changes in Self-Compassion From Baseline (week 0) to Post-Intervention (week 10) | Baseline (week 0) and Post-Intervention (week 10) | Self-compassion will be assessed using the Self-Compassion Scale - Short Form (SCS-SF), a 12-item self-report questionnaire measuring individuals' ability to adopt a compassionate attitude toward themselves. Items are rated on a five-point Likert scale ranging from 1 (almost never) to 5 (almost always). The overall score is calculated by averaging the 12 items, after reverse-scoring negatively worded items, and ranges from 1 to 5, with higher scores indicating greater levels of self-compassion. | ClinicalTrials.gov |
| Secondary | Changes in Parental Reflective Functioning From Baseline (week 0) to Post-Intervention (week 10) | Baseline (week 0) and Post-Intervention (week 10) | Parental reflective functioning will be assessed using the Parental Reflective Functioning Questionnaire (PRFQ), an 18-item multidimensional self-report measure assessing parents' capacity to reflect on their children's mental states. Items are rated on a seven-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The instrument comprises three six-item subscales: (a) Pre-Mentalizing Modes of Mental States; (b) Certainty about Mental States; and (c) Interest and Curiosity in Mental States. Each subscale score is calculated as the mean of its six items, after reverse-scoring where appropriate, and ranges from 1 to 7. Higher scores on Pre-Mentalizing indicate greater difficulties in interpreting the child's mental states. Higher scores on Certainty about Mental States indicate greater certainty regarding the child's thoughts and feelings. Higher scores on Interest and Curiosity indicate greater parental interest in the child's mental experiences. | ClinicalTrials.gov |
| Other | Intervention Acceptability | Post-Intervention (week 10) | Intervention acceptability will be assessed using a study-specific Final Evaluation Form developed by the research team. The form will assess participants' overall satisfaction with the program, perceived usefulness and impact on parenting, willingness to recommend the program to others, usability of the online platform (e.g., ease of use, navigation, and clarity of instructions), compatibility with daily routines, perceptions of the intervention format (e.g., session length and overall duration), and adequacy of contact with the research team. Closed-ended items will be rated on a five-point Likert scale ranging from 1 (very negative evaluation) to 5 (very positive evaluation), with higher scores indicating greater intervention acceptability (a better outcome). Each item will be analyzed separately, with scores ranging from 1 to 5. Open-ended questions will allow participants to identify the most and least helpful aspects of the program and provide suggestions for improvement. | ClinicalTrials.gov |
| Other | Feasibility of the Intervention | Post-Intervention (week 10) | Program feasibility will be assessed through adherence, engagement, and attrition. Adherence will be measured by the number of sessions completed (0-8) and the percentage of participants completing at least 75% of the program (6 of 8 sessions) within 10 weeks. Engagement will be assessed using platform data, including time spent per session (minutes), pages viewed, interactive exercises completed (%), and home practice activities submitted (%). Intervention attrition will be defined as the percentage of intervention participants completing fewer than six sessions within 10 weeks. Trial attrition will be calculated as the percentage of randomized participants who do not complete the post-intervention (up to Week 10) assessments. | ClinicalTrials.gov |
| Other | Resource utilization | Baseline (week 0) and Post-Intervention (week 10) | Participants' resource utilization will be assessed retrospectively through a Resource Use Questionnaire developed by the research team based on previously published instruments. The questionnaire will collect information regarding resource utilization for both participants and their children, including healthcare utilization (e.g., emergency department visits, outpatient appointments, hospitalizations, and medication use), absenteeism and presenteeism related to paid and unpaid work among caregivers, and out-of-pocket expenses. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)