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| ID | Type | Description | Link |
|---|---|---|---|
| R56MH127032 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Maternal depression influences the development of children's behavior problems and vice versa; however most interventions singularly address maternal depression or children's behavior problems rather than both. This project assesses the efficacy of an intervention that treats both mothers and children in an integrated manner. Effects are expected to disrupt the reciprocal relations that perpetuate maternal and child mental health problems over time.
The proposed project is a pilot randomized controlled trial to evaluate the effectiveness of an integrated intervention that dually treats maternal depressive symptoms and offspring behavior problems. Families (n = 40 mothers and their 2-to-4 year-old children) will be randomized to receive 10 sessions of ABC or 10 sessions of ABC+D in their home. ABC+D is an expanded version of ABC that additionally treats maternal depressive symptoms using Mothers and Babies adapted for mothers of toddlers. The specific aims of this proposed project are:
Aim 1. Collect preliminary data on the feasibility and acceptability of ABC+D in preparation for a small pilot randomized controlled trial (RCT).
Aim 2. Conduct a small pilot RCT to examine the effectiveness of ABC and ABC+D
Aim 3: Assess the overall acceptability (mother- and provider-rated), appropriateness (mother- and provider-rated), and feasibility (provider-rated) of ABC+D. Mothers will also rate their satisfaction with each session and the degree to which it was helpful, interesting, and comprehensible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC | Active Comparator | Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support |
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| ABC+D | Experimental | Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attachment and Biobehavioral Catch up | Behavioral | ABC is delivered by a trained parent coach. The parent coach provides information about parenting and child development. The focus is on providing support for parents of young children and improving the parent-child relationship. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score | Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms | Baseline to post-intervention. This is approximately 10 weeks. |
| Change in Early Childhood Screening Assessment (ECSA) Score | Scores range from 0 to 80 with higher values indicating more severe symptoms | Baseline to post-intervention. This is approximately 10 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Roubinov, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94118 | United States |
Data will be shared via the NIMH Data Archive (NDA)
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Data from this clinical trial require significant processing after the completion of data collection. We will submit a clean dataset after the final data lock.
Researchers will the appropriate qualifications can request the dataset via the NIMH Data Archive Platform.
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The number of enrolled participants reflect the total number of mothers and children. There were 38 dyads enrolled in the study reflecting 38 mothers and 38 offspring (76 total participants).
Participants were recruited between March 2022 and August 2024. Recruitment occurred online.
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| ID | Title | Description |
|---|---|---|
| FG000 | Attachment and Biobehavioral Catch-up (ABC) | Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support Attachment and Biobehavioral Catch up: ABC is delivered by a trained parent coach. The parent coach provides information about parenting and child development. The focus is on providing support for parents of young children and improving the parent-child relationship. |
| FG001 | Attachment and Biobehavioral Catch-up Plus Depression Treatment (ABC+D) | Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping Attachment and Biobehavioral Catch up Plus Depression Treatment: ABC+D offers the same 10-sessions of parenting support that is provided by ABC and additionally provides weekly short videos that help mothers develop skills for coping with stress and regulating mood. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Number of baseline participants reflects dyads (i.e., 16 mothers and 16 children in ABC = 32 total and 22 mothers and 22 children in ABC+D = 44 total).
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| ID | Title | Description |
|---|---|---|
| BG000 | Attachment and Biobehavioral Catch-up (ABC) | Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support Attachment and Biobehavioral Catch up: ABC is delivered by a trained parent coach. The parent coach provides information about parenting and child development. The focus is on providing support for parents of young children and improving the parent-child relationship. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score | Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms | Data is missing for one individual in the ABC+D condition. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-intervention. This is approximately 10 weeks. |
|
From enrollment through post-intervention. This is approximately 12 weeks.
There were no adverse events during the course of the study for participants assigned to ABC. There were no adverse events during the course of the study for participants assigned to ABC+D
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attachment and Biobehavioral Catch-up (ABC) | Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support Attachment and Biobehavioral Catch up: ABC is delivered by a trained parent coach. The parent coach provides information about parenting and child development. The focus is on providing support for parents of young children and improving the parent-child relationship. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle Roubinov | University of North Carolina at Chapel Hill | 9198435898 | danielle_roubinov@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2023 | Jan 15, 2026 | Prot_SAP_000.pdf |
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|
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| Attachment and Biobehavioral Catch up Plus Depression Treatment | Behavioral | ABC+D offers the same 10-sessions of parenting support that is provided by ABC and additionally provides weekly short videos that help mothers develop skills for coping with stress and regulating mood. |
|
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| BG001 | Attachment and Biobehavioral Catch-up (ABC+D) | Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping Attachment and Biobehavioral Catch up Plus Depression Treatment: ABC+D offers the same 10-sessions of parenting support that is provided by ABC and additionally provides weekly short videos that help mothers develop skills for coping with stress and regulating mood. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age in years | There were 38 dyads enrolled in the study (16 dyads in the ABC group, n = 32; 22 dyads in the ABC+D group, n = 44). This reflects an overall total of n = 76 participants ((38 dyads). Age in years is reported separately for mothers and children | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Mother and child biological sex reported separately | Mother and child biological sex reported separately | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Mother and child ethnicity reported separately | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Mother and child race reported separately | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| OG001 | Attachment and Biobehavioral Catch-up (ABC) | Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support Attachment and Biobehavioral Catch up: ABC is delivered by a trained parent coach. The parent coach provides information about parenting and child development. The focus is on providing support for parents of young children and improving the parent-child relationship. |
|
|
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| Primary | Change in Early Childhood Screening Assessment (ECSA) Score | Scores range from 0 to 80 with higher values indicating more severe symptoms | Data is missing on one individual from the ABC+D condition | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-intervention. This is approximately 10 weeks. |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Attachment and Biobehavioral Catch-up Plus Depression Treatment (ABC+D) | Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping Attachment and Biobehavioral Catch up Plus Depression Treatment: ABC+D offers the same 10-sessions of parenting support that is provided by ABC and additionally provides weekly short videos that help mothers develop skills for coping with stress and regulating mood. | 0 | 44 | 0 | 44 | 0 | 44 |
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| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|