Anxiety Symptoms, Depressive Symptoms
Conditions
Brief summary
The overarching goal is to pilot the Attachment and Biobehavioral Catch-up (ABC) intervention for mothers with heightened depressive symptom and their children with heightened internalizing symptoms.
Detailed description
Exposure to maternal depressive symptoms increases children's risk for developing anxiety and depressive symptoms (internalizing symptoms). Maternal depressive symptoms and children's internalizing symptoms may be reciprocally related over time. Optimal interventions for children's internalizing symptoms may involve treatment components for mothers, children, and the maternal-child relationship. The Attachment and Biobehavioral Catch-up (ABC) intervention is a empirically-supported, family-based treatment program that has been shown to be beneficial for children in varied high-risk family environments, but has yet to be tested among mothers and children recruited on the basis of heightened depressive and internalizing symptoms, respectively. The overarching goal is to examine the acceptability, feasibility, and preliminary effects of the ABC program on a sample of mother-child dyads (n = 20) with heightened depressive and internalizing symptoms. Our specific aims are: 1. To evaluate the feasibility and acceptability of ABC for mothers with depressive symptoms and their offspring with internalizing symptoms 2. To explore whether children who receive ABC show improvement in internalizing symptoms from pre- to post-intervention 3. To explore whether mothers who receive ABC show improvement in depressive symptoms from pre- to post-intervention 4. To explore whether parents and children who receive ABC show more adaptive physiological responses to stress from pre- to post-intervention
Interventions
BEHAVIORALAttachment and Biobehavioral Catch-up (ABC) Intervention
ABC is a 10 session, home-based, dyadic therapy that is delivered by a trained professional. The sessions focus on improving the parent-child relationship and children's biological and behavioral responses to stress.
Sponsors
National Institute of Mental Health (NIMH)
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Mothers between 18 and 50 years of age with heightened depressive symptoms as determined by a score of 16 or higher on the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) 2. Biological children (of mothers described above) between 2 and 4 years old with heightened internalizing symptoms as determined by a T-score of 60 or higher on the Childhood Behavior Checklist (CBCL)
Exclusion criteria
* Self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt * Current pregnancy * Child diagnosis of autism * Pacemaker implant, cardiac problems, cardiac medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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)) | Change in score from baseline at post-intervention (week 10). | 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. |
| 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)) | Change in score from baseline at post-intervention (week 10) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between August 2020 and March 2021. Recruitment occurred online.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Attachment and Biobehavioral Catch-up (ABC) 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. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Attachment and Biobehavioral Catch-up (ABC) |
|---|---|
| Age, Categorical <=18 years | 21 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous Child age | 2.82 years STANDARD_DEVIATION 0.63 |
| Age, Continuous Maternal age | 36.45 years STANDARD_DEVIATION 4.05 |
| Center for Epidemiologic Studies Depression Scale (CES-D) | 26.57 units on a scale STANDARD_DEVIATION 7.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Internalizing subscale of the Child Behavior Checklist (CBCL) | 16.95 units on a scale STANDARD_DEVIATION 9.56 |
| Race (NIH/OMB) Child race American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Child race Asian | 2 Participants |
| Race (NIH/OMB) Child race Black or African American | 0 Participants |
| Race (NIH/OMB) Child race More than one race | 5 Participants |
| Race (NIH/OMB) Child race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Child race Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Child race White | 14 Participants |
| Race (NIH/OMB) Maternal race American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Maternal race Asian | 7 Participants |
| Race (NIH/OMB) Maternal race Black or African American | 1 Participants |
| Race (NIH/OMB) Maternal race More than one race | 0 Participants |
| Race (NIH/OMB) Maternal race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Maternal race Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) Maternal race White | 12 Participants |
| Region of Enrollment United States | 42 Participants |
| Sex: Female, Male Mother Female | 21 Participants |
| Sex: Female, Male Mother Male | 0 Participants |
| Sex: Female, Male Offspring Female | 3 Participants |
| Sex: Female, Male Offspring Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
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))
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.
Time frame: Change in score from baseline at post-intervention (week 10)
Population: Outcome data was completed by 20 mothers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attachment and Biobehavioral Catch-up (ABC) | 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 |
p-value: <0.01t-test, 2 sided
Primary
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))
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.
Time frame: Change in score from baseline at post-intervention (week 10).
Population: Outcome data was completed by mothers for 20 children.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attachment and Biobehavioral Catch-up (ABC) | 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 |
p-value: <0.01t-test, 2 sided