Trial · NCT04639557
Building Regulation in Dual Generations - Telehealth Model
NCT04639557, Not applicable, Completed, University of Manitoba
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Building Regulation in Dual Generations - Telehealth Model. Trials, record NCT04639557. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04639557
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Building Regulation in Dual Generations - Telehealth Model
- NCT number
- NCT04639557
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 40 participants, actual
- Lead sponsor
- University of Manitoba
- Conditions
- Maternal Depression, Child Development, Child Mental Health
- Interventions
- BRIDGE Therapy Program
- First posted
- 2020-11-20
- Last updated
- 2024-05-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Maternal Depression from pre-intervention to post-intervention - Beck Depression Inventory | The Beck Depression Inventory will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time once again after the program is complete (approx. 20 weeks after Time 1). | 21-item self-report inventory to measure symptoms and characteristics of depression. Participants respond to statements on a 0-3 Likert scale. Higher scores indicate higher depression symptoms. The highest possible score is 60 and lowest possible score is 0. |
| Primary | Change in Maternal Emotion Regulation pre-intervention to post-intervention - Difficulties in Emotion Regulation Scale | The Difficulties in Emotion Regulation Scale will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and Time 2 once again after the program is complete (approx. 20 weeks after Time 1). | 18-item self-report questionnaire with 6 sub-categories to measure emotion regulation. Participants respond to items on a 5-point Likert scale. Higher scores suggest more severe problems with emotion regulation. The highest possible score is 90 and the lowest possible score is 18. |
| Primary | 3. Change in Parenting Stress from pre-intervention to post-intervention - Parenting Stress Index (Short form) | The Parenting Stress Index (short form) will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 weeks after Time 1). | 36-item self-report measure filled out by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. There are 3 sub categories. Responses to each item in a sub-category are totalled and then the 3 subcategory scores are summed to represent a total stress score. Higher scores indicated 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 the Child Behaviour Checklist from pre-intervention to post-intervention | The Child Behaviour Checklist will be completed by participants at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 weeks after Time 1). | 103-item questionnaire that asks parents to describe their child's behavioural and emotional problems within the past 2 months. |
| Secondary | Change in Parental Sensitivity from pre-intervention to post-intervention | Parent-child interactions will be observed and video coded at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 weeks after Time 1). | Parent-child interactions will be video recorded after the child has participated in an acute stressor task. The interaction will be coded to measure levels of parental sensitivity using a novel coding scale (no established range). |
| Other | Change in Child Cognitive Function from pre-intervention to post-intervention - Exploratory Outcome | Child cognitive function will be assessed at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 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 | 2. Change in Child Stress System Reactivity and Recovery from pre-intervention to post-intervention - Exploratory Outcome | Child stress system reactivity and recovery will be measured at Time 1 prior to the beginning of the BRIDGE Therapy Program and at Time 2 once again after the program is complete (approx. 20 weeks after Time 1). | Child stress system reactivity will be measured through heartrate and salivary cortisol. Children will participate in an acute stressor task during which they will be wearing a FitBit heart rate monitor that will be recording their heartrate during the task. Salivary cortisol will also be collected immediately before the acute stressor, immediately after, and then 15, 30, and 45 minutes after. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38923527 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
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 |
|---|---|
| Stroop Color-Word Test | Other outcome |
Source ConductCognition
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04639557
GET https://conductscience.org/api/trials/v1/NCT04639557/registered