Trial Outcomes & Findings for Attachment and Biobehavioral Catch-up for Depression (NCT NCT04050202)
NCT ID: NCT04050202
Last Updated: 2024-07-22
Results Overview
The internalizing subscale of the CBCL is a validated measure of emotional withdrawal, reactivity, sadness, anxiety, and other symptoms completed by mothers about their children. Scores range from 0 to 72 with higher scores indicating more severe symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Change in score from baseline at post-intervention (week 10).
Results posted on
2024-07-22
Participant Flow
Participants were recruited between August 2020 and March 2021. Recruitment occurred online.
The numbers of enrolled participants reflect the total number of mothers and children. There were 21 dyads enrolled in the study reflecting 21 mothers and their 21 offspring (42 total participants).
Participant milestones
| Measure |
Attachment and Biobehavioral Catch-up (ABC)
ABC delivers therapy through 10 weekly sessions that are led by a trained professional ("parent coach"). Treatment content is based on attachment theory and an understanding of children's stress neurobiology. Components aim to improve parental sensitivity, nurturance, and responsivity. Parents are supported to improve the quality of their interactions with their children through frequent "in-the-moment" comments that are provided to them by the parent coach. All comments are positive initially; these comments highlight adaptive behaviors the parent is engaging in and the positive effect that they have on their children. Once rapport is established, the parent coach begins to offer suggested modifications or behaviors the parent may want to discontinue as they are likely to be dysregulating for the child.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Attachment and Biobehavioral Catch-up (ABC)
ABC delivers therapy through 10 weekly sessions that are led by a trained professional ("parent coach"). Treatment content is based on attachment theory and an understanding of children's stress neurobiology. Components aim to improve parental sensitivity, nurturance, and responsivity. Parents are supported to improve the quality of their interactions with their children through frequent "in-the-moment" comments that are provided to them by the parent coach. All comments are positive initially; these comments highlight adaptive behaviors the parent is engaging in and the positive effect that they have on their children. Once rapport is established, the parent coach begins to offer suggested modifications or behaviors the parent may want to discontinue as they are likely to be dysregulating for the child.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
There were 21 mothers and 21 offspring. Age is reported separately for each. This sums to 42 total participants.
Baseline characteristics by cohort
| Measure |
Attachment and Biobehavioral Catch-up (ABC)
n=42 Participants
ABC delivers therapy through 10 sessions led by a trained professional ("parent coach"). Treatment content is based on principles of attachment theory and an understanding of children's stress neurobiology. Each session is structured with content that aims to improve parental sensitivity, nurturance, and responsivity. Parents are provided with ongoing feedback ("in the moment" comments from the parent coach) that reinforces adaptive parenting behaviors and helps gently adapt non-adaptive or negative parenting behaviors.
|
|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=42 Participants
|
|
Age, Continuous
Maternal age
|
36.45 years
STANDARD_DEVIATION 4.05 • n=21 Participants • There were 21 mothers and 21 offspring. Age is reported separately for each. This sums to 42 total participants.
|
|
Age, Continuous
Child age
|
2.82 years
STANDARD_DEVIATION 0.63 • n=21 Participants • There were 21 mothers and 21 offspring. Age is reported separately for each. This sums to 42 total participants.
|
|
Sex: Female, Male
Mother · Female
|
21 Participants
n=21 Participants • There were 21 mothers and 21 offspring. Mothers and offspring data are reported separately, but sum to the overall number of baseline participants.
|
|
Sex: Female, Male
Mother · Male
|
0 Participants
n=21 Participants • There were 21 mothers and 21 offspring. Mothers and offspring data are reported separately, but sum to the overall number of baseline participants.
|
|
Sex: Female, Male
Offspring · Female
|
3 Participants
n=21 Participants • There were 21 mothers and 21 offspring. Mothers and offspring data are reported separately, but sum to the overall number of baseline participants.
|
|
Sex: Female, Male
Offspring · Male
|
18 Participants
n=21 Participants • There were 21 mothers and 21 offspring. Mothers and offspring data are reported separately, but sum to the overall number of baseline participants.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Maternal race · American Indian or Alaska Native
|
0 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Maternal race · Asian
|
7 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Maternal race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Maternal race · Black or African American
|
1 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Maternal race · White
|
12 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Maternal race · More than one race
|
0 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Maternal race · Unknown or Not Reported
|
1 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Child race · American Indian or Alaska Native
|
0 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Child race · Asian
|
2 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Child race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Child race · Black or African American
|
0 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Child race · White
|
14 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Child race · More than one race
|
5 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Race (NIH/OMB)
Child race · Unknown or Not Reported
|
0 Participants
n=21 Participants • Maternal race and child race were collected separately. There were 21 mothers and 21 children, summing to the total of 42 participants.
|
|
Region of Enrollment
United States
|
42 Participants
n=42 Participants
|
|
Center for Epidemiologic Studies Depression Scale (CES-D)
|
26.57 units on a scale
STANDARD_DEVIATION 7.99 • n=21 Participants • The CES-D is an adult measure of depressive symptoms. This information was only collected from the sample of mothers (n = 21).
|
|
Internalizing subscale of the Child Behavior Checklist (CBCL)
|
16.95 units on a scale
STANDARD_DEVIATION 9.56 • n=21 Participants • The internalizing subscale measures child symptoms. It was only completed by mothers about the n = 21 children who participated in the study.
|
PRIMARY outcome
Timeframe: Change in score from baseline at post-intervention (week 10).Population: Outcome data was completed by mothers for 20 children.
The internalizing subscale of the CBCL is a validated measure of emotional withdrawal, reactivity, sadness, anxiety, and other symptoms completed by mothers about their children. Scores range from 0 to 72 with higher scores indicating more severe symptoms.
Outcome measures
| Measure |
Attachment and Biobehavioral Catch-up (ABC)
n=20 Participants
ABC is a 10 session intervention that aims to improve parental sensitivity, nurturance, and responsivity.
|
|---|---|
|
Change From Baseline in Internalizing Subscale Score of the Child Behavior Checklist (CBCL) at Week 10 (Value at Baseline Minus Value at Post Intervention (Week 10))
|
8.5 units on a scale
Standard Deviation 6.09
|
PRIMARY outcome
Timeframe: Change in score from baseline at post-intervention (week 10)Population: Outcome data was completed by 20 mothers.
The CES-D is a validated self-report instrument of depressive symptoms. Scores range from 0 to 60 with higher values indicating more severe symptoms.
Outcome measures
| Measure |
Attachment and Biobehavioral Catch-up (ABC)
n=20 Participants
ABC is a 10 session intervention that aims to improve parental sensitivity, nurturance, and responsivity.
|
|---|---|
|
Change From Baseline in Center for Epidemiologic Studies-Depression Scale (CES-D) at Week 10 (Value at Baseline Minus Value at Post Intervention (Week 10))
|
12.6 units on a scale
Standard Deviation 7.73
|
Adverse Events
Attachment and Biobehavioral Catch-up (ABC)
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, PhD
University of California, San Francisco
Phone: 919-843-5898
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place