Trial Outcomes & Findings for Attachment and Biobehavioral Catch-up and Depression Treatment (NCT NCT05096611)
NCT ID: NCT05096611
Last Updated: 2026-04-21
Results Overview
Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
Baseline to post-intervention. This is approximately 10 weeks.
Results posted on
2026-04-21
Participant Flow
Participants were recruited between March 2022 and August 2024. Recruitment occurred online.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
22
|
|
Overall Study
COMPLETED
|
16
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Attachment and Biobehavioral Catch-up (ABC)
n=32 Participants
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.
|
Attachment and Biobehavioral Catch-up (ABC+D)
n=44 Participants
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.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=32 Participants
|
22 Participants
n=44 Participants
|
38 Participants
n=76 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=32 Participants
|
22 Participants
n=44 Participants
|
38 Participants
n=76 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=32 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=76 Participants
|
|
Age, Continuous
Mother age in years
|
34.63 Years
STANDARD_DEVIATION 8.09 • n=32 Participants • 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
|
33.17 Years
STANDARD_DEVIATION 4.64 • n=44 Participants • 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
|
33.79 Years
STANDARD_DEVIATION 6.27 • n=76 Participants • 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
|
|
Age, Continuous
Child age in years
|
2.96 Years
STANDARD_DEVIATION 0.43 • n=32 Participants • 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
|
3.38 Years
STANDARD_DEVIATION 0.74 • n=44 Participants • 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
|
3.20 Years
STANDARD_DEVIATION 0.65 • n=76 Participants • 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
|
|
Sex: Female, Male
Mother biological sex · Female
|
16 Participants
n=16 Participants • Mother and child biological sex reported separately
|
22 Participants
n=22 Participants • Mother and child biological sex reported separately
|
38 Participants
n=38 Participants • Mother and child biological sex reported separately
|
|
Sex: Female, Male
Mother biological sex · Male
|
0 Participants
n=16 Participants • Mother and child biological sex reported separately
|
0 Participants
n=22 Participants • Mother and child biological sex reported separately
|
0 Participants
n=38 Participants • Mother and child biological sex reported separately
|
|
Sex: Female, Male
Child biological sex · Female
|
13 Participants
n=16 Participants • Mother and child biological sex reported separately
|
13 Participants
n=22 Participants • Mother and child biological sex reported separately
|
26 Participants
n=38 Participants • Mother and child biological sex reported separately
|
|
Sex: Female, Male
Child biological sex · Male
|
3 Participants
n=16 Participants • Mother and child biological sex reported separately
|
9 Participants
n=22 Participants • Mother and child biological sex reported separately
|
12 Participants
n=38 Participants • Mother and child biological sex reported separately
|
|
Ethnicity (NIH/OMB)
Mother ethnicity · Hispanic or Latino
|
12 Participants
n=16 Participants • Mother and child ethnicity reported separately
|
14 Participants
n=22 Participants • Mother and child ethnicity reported separately
|
26 Participants
n=38 Participants • Mother and child ethnicity reported separately
|
|
Ethnicity (NIH/OMB)
Mother ethnicity · Not Hispanic or Latino
|
4 Participants
n=16 Participants • Mother and child ethnicity reported separately
|
8 Participants
n=22 Participants • Mother and child ethnicity reported separately
|
12 Participants
n=38 Participants • Mother and child ethnicity reported separately
|
|
Ethnicity (NIH/OMB)
Mother ethnicity · Unknown or Not Reported
|
0 Participants
n=16 Participants • Mother and child ethnicity reported separately
|
0 Participants
n=22 Participants • Mother and child ethnicity reported separately
|
0 Participants
n=38 Participants • Mother and child ethnicity reported separately
|
|
Ethnicity (NIH/OMB)
Child ethnicity · Hispanic or Latino
|
10 Participants
n=16 Participants • Mother and child ethnicity reported separately
|
14 Participants
n=22 Participants • Mother and child ethnicity reported separately
|
24 Participants
n=38 Participants • Mother and child ethnicity reported separately
|
|
Ethnicity (NIH/OMB)
Child ethnicity · Not Hispanic or Latino
|
6 Participants
n=16 Participants • Mother and child ethnicity reported separately
|
8 Participants
n=22 Participants • Mother and child ethnicity reported separately
|
14 Participants
n=38 Participants • Mother and child ethnicity reported separately
|
|
Ethnicity (NIH/OMB)
Child ethnicity · Unknown or Not Reported
|
0 Participants
n=16 Participants • Mother and child ethnicity reported separately
|
0 Participants
n=22 Participants • Mother and child ethnicity reported separately
|
0 Participants
n=38 Participants • Mother and child ethnicity reported separately
|
|
Race (NIH/OMB)
Mother race · American Indian or Alaska Native
|
0 Participants
n=16 Participants • Mother and child race reported separately
|
0 Participants
n=22 Participants • Mother and child race reported separately
|
0 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Mother race · Asian
|
3 Participants
n=16 Participants • Mother and child race reported separately
|
2 Participants
n=22 Participants • Mother and child race reported separately
|
5 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Mother race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants • Mother and child race reported separately
|
1 Participants
n=22 Participants • Mother and child race reported separately
|
1 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Mother race · Black or African American
|
1 Participants
n=16 Participants • Mother and child race reported separately
|
2 Participants
n=22 Participants • Mother and child race reported separately
|
3 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Mother race · White
|
5 Participants
n=16 Participants • Mother and child race reported separately
|
7 Participants
n=22 Participants • Mother and child race reported separately
|
12 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Mother race · More than one race
|
2 Participants
n=16 Participants • Mother and child race reported separately
|
3 Participants
n=22 Participants • Mother and child race reported separately
|
5 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Mother race · Unknown or Not Reported
|
5 Participants
n=16 Participants • Mother and child race reported separately
|
7 Participants
n=22 Participants • Mother and child race reported separately
|
12 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Child race · American Indian or Alaska Native
|
0 Participants
n=16 Participants • Mother and child race reported separately
|
0 Participants
n=22 Participants • Mother and child race reported separately
|
0 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Child race · Asian
|
1 Participants
n=16 Participants • Mother and child race reported separately
|
2 Participants
n=22 Participants • Mother and child race reported separately
|
3 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Child race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants • Mother and child race reported separately
|
0 Participants
n=22 Participants • Mother and child race reported separately
|
0 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Child race · Black or African American
|
2 Participants
n=16 Participants • Mother and child race reported separately
|
2 Participants
n=22 Participants • Mother and child race reported separately
|
4 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Child race · White
|
3 Participants
n=16 Participants • Mother and child race reported separately
|
7 Participants
n=22 Participants • Mother and child race reported separately
|
10 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Child race · More than one race
|
5 Participants
n=16 Participants • Mother and child race reported separately
|
5 Participants
n=22 Participants • Mother and child race reported separately
|
10 Participants
n=38 Participants • Mother and child race reported separately
|
|
Race (NIH/OMB)
Child race · Unknown or Not Reported
|
5 Participants
n=16 Participants • Mother and child race reported separately
|
6 Participants
n=22 Participants • Mother and child race reported separately
|
11 Participants
n=38 Participants • Mother and child race reported separately
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
44 participants
n=44 Participants
|
38 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: Baseline to post-intervention. This is approximately 10 weeks.Population: Data is missing for one individual in the ABC+D condition.
Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms
Outcome measures
| Measure |
Attachment and Biobehavioral Catch-up Plus Depression Treatment (ABC+D)
n=21 Participants
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.
|
Attachment and Biobehavioral Catch-up (ABC)
n=16 Participants
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.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
|
6.70 units on a scale
Standard Deviation 6.38
|
6.98 units on a scale
Standard Deviation 10.49
|
PRIMARY outcome
Timeframe: Baseline to post-intervention. This is approximately 10 weeks.Population: Data is missing on one individual from the ABC+D condition
Scores range from 0 to 80 with higher values indicating more severe symptoms
Outcome measures
| Measure |
Attachment and Biobehavioral Catch-up Plus Depression Treatment (ABC+D)
n=16 Participants
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.
|
Attachment and Biobehavioral Catch-up (ABC)
n=21 Participants
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.
|
|---|---|---|
|
Change in Early Childhood Screening Assessment (ECSA) Score
|
10.12 units on a scale
Standard Deviation 14.15
|
8.67 units on a scale
Standard Deviation 14.78
|
Adverse Events
Attachment and Biobehavioral Catch-up (ABC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attachment and Biobehavioral Catch-up Plus Depression Treatment (ABC+D)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Danielle Roubinov
University of North Carolina at Chapel Hill
Phone: 9198435898
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place