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Attachment & Biobehavioral Therapy + Depression Treatment for Depression & Disruptive Behaviors (ABC+D Trial)
N/A
Waitlist Available
Led By Danielle Roubinov, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English- or Spanish-speaking
Mothers 18 years of age or older with heightened depressive symptoms as determined by a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9)
Must not have
Self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to post-intervention. this is an anticipated average of 10 weeks.
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether an intervention that treats both mothers and children together is more effective than treating just one or the other.
Who is the study for?
This trial is for mothers over 18 with significant depressive symptoms and their biological children aged 2-4 who show heightened behavior problems. Mothers must score at least 16 on the CESD-R depression scale, and children need a score of 18+ on the ECSA behavior assessment. It's not for those with a child diagnosed with autism or mothers with psychosis or active suicidality.
What is being tested?
The study tests an integrated treatment approach addressing both maternal depression and children's behavioral issues simultaneously. One group receives Attachment and Biobehavioral Catch-up (ABC) plus additional depression therapy, while another just gets ABC to see if combined treatment is more effective.
What are the potential side effects?
Since this trial involves psychological interventions rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort or distress as they address sensitive personal issues during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English or Spanish.
Select...
I am a mother over 18 with depression symptoms scoring 5+ on the PHQ-9.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of psychosis or have recently planned or attempted suicide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to post-intervention. this is an anticipated average of 10 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to post-intervention. this is an anticipated average of 10 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Early Childhood Screening Assessment score
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ABC+DExperimental Treatment1 Intervention
Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping
Group II: ABCActive Control1 Intervention
Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,751,565 Total Patients Enrolled
20 Trials studying Postpartum Depression
7,722 Patients Enrolled for Postpartum Depression
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,874 Total Patients Enrolled
3 Trials studying Postpartum Depression
1,078 Patients Enrolled for Postpartum Depression
Danielle Roubinov, PhDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
1,857 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of psychosis or have recently planned or attempted suicide.I speak English or Spanish.I am a mother over 18 with depression symptoms scoring 5+ on the PHQ-9.My child, aged 2-4, has significant behavior issues as per a specific rating scale.
Research Study Groups:
This trial has the following groups:- Group 1: ABC
- Group 2: ABC+D
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.