Depressive SymptomsABCNCT04050202

Attachment and Biobehavioral Catch-up for Depression

A study testing Attachment and Biobehavioral Catch-up (ABC) Intervention in people with Depressive Symptoms and Anxiety Symptoms, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Depressive Symptoms, Anxiety Symptoms
What is being tested?: Attachment and Biobehavioral Catch-up (ABC) Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2020to 30 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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)
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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94107

Other trials in United States

About this study

Official title: Attachment and Biobehavioral Catch-up for Depression Intervention

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.

Read the 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:

To evaluate the feasibility and acceptability of ABC for mothers with depressive symptoms and their offspring with internalizing symptoms
To explore whether children who receive ABC show improvement in internalizing symptoms from pre- to post-intervention
To explore whether mothers who receive ABC show improvement in depressive symptoms from pre- to post-intervention
To explore whether parents and children who receive ABC show more adaptive physiological responses to stress from pre- to post-intervention

Conditions: Depressive Symptoms, Anxiety Symptoms
Being tested: Attachment and Biobehavioral Catch-up (ABC) Intervention
Medical subject headings: Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Attachment and Biobehavioral Catch-up (ABC) InterventionBehavioural
Also called ABC
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.

Study groups in NCT04050202
Study group	Role	What they receive
ABC	Experimental	ABC delivers therapy through 10, home-based, in-person sessions led by a trained professional. Treatment content is based on attachment theory and an understanding of children's stress neurobiology. Components aim to improve parental sensitivity, nurturance, and responsivity, as well as children's biological and behavioral reactivity through dyadic interactions between parents and children. Receives: Behavioral: Attachment and Biobehavioral Catch-up (ABC) Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change in score from baseline at post-intervention (week 10).
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.
Measured: Change in score from baseline at post-intervention (week 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202030 Sep 2022

First posted8 Aug 2019
Study start1 Aug 2020
Primary completion30 Sep 2022
Study completion30 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Depressive SymptomsStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04050202
Sponsor's protocol ID: A130886
Other IDs: K23MH113709
Acronym: ABC
Status last verified: Jul 2024
First submitted: 7 Aug 2019
Last updated: 22 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Attachment and Biobehavioral Catch-up for Depression Intervention
ClinicalTrials.gov ID: NCT04050202
Acronym / sponsor ID: ABC / A130886
Conditions: Depressive Symptoms, Anxiety Symptoms
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Aug 2020 (actual)
Primary completion: 30 Sep 2022 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 8 Aug 2019 (actual)
Results: Posted 22 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

To evaluate the feasibility and acceptability of ABC for mothers with depressive symptoms and their offspring with internalizing symptoms
To explore whether children who receive ABC show improvement in internalizing symptoms from pre- to post-intervention
To explore whether mothers who receive ABC show improvement in depressive symptoms from pre- to post-intervention
To explore whether parents and children who receive ABC show more adaptive physiological responses to stress from pre- to post-intervention

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ABC	Experimental	Behavioral: Attachment and Biobehavioral Catch-up (ABC) InterventionABC delivers therapy through 10, home-based, in-person sessions led by a trained professional. Treatment content is based on attachment theory and an understanding of children's stress neurobiology. Components aim to improve parental sensitivity, nurturance, and responsivity, as well as children's biological and behavioral reactivity through dyadic interactions between parents and children.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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)
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)

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Attachment and Biobehavioral Catch-up (ABC) InterventionAlso: ABCABC 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.	Behavioural	ABC

Primary outcome

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))
Time frame: 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))
Time frame: 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.

Results and safety

Results posted to the registry on 22 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Attachment and Biobehavioral Catch-up (ABC)	42	40

Primary outcome: 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))

Time frame: Change in score from baseline at post-intervention (week 10).. Mean (Standard Deviation). Unit: units on a scale

Measure	Attachment and Biobehavioral Catch-up (ABC) n = 20
Value	8.5 (6.09)

Attachment and Biobehavioral Catch-up (ABC): Mean Difference (Net): 8.45, p <0.01, t-test, 2 sided

Population analysed: Outcome data was completed by mothers for 20 children.

Primary outcome: 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))

Time frame: Change in score from baseline at post-intervention (week 10). Mean (Standard Deviation). Unit: units on a scale

Measure	Attachment and Biobehavioral Catch-up (ABC) n = 20
Value	12.6 (7.73)

Attachment and Biobehavioral Catch-up (ABC): Mean Difference (Net): 13.97, p <0.01, t-test, 2 sided

Population analysed: Outcome data was completed by 20 mothers.

Adverse events

Time frame: Adverse event data were collected over a 1 year period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Attachment and Biobehavioral Catch-up (ABC)	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Limitations and caveats (from the sponsor): Onset of the COVID-19 pandemic during the middle of the study. Some families completed the intervention in person and other families completed it virtually or a mix of in-person and virtual visits.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Danielle Roubinov, PhD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)) (time frame: Change in score from baseline at post-intervention (week 10).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04050202.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.