Attachment & Biobehavioral Therapy + Depression Treatment for Depression & Disruptive Behaviors

(ABC+D Trial)

Overseen By Danielle Roubinov, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Psychosis, Suicidality, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy approach called Attachment and Biobehavioral Catch-up, designed to assist mothers and their young children facing depression and behavior problems. The goal is to determine if treating both together can break the cycle perpetuating these issues. The trial consists of two parts: one includes parenting support sessions, and the other adds short videos to help mothers manage mood and stress. It suits mothers who feel depressed, have children aged 2 to 4 with behavior challenges, and speak English or Spanish. As an unphased trial, this study offers participants a unique opportunity to access innovative therapy approaches that could significantly enhance their well-being.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Attachment and Biobehavioral Catch-up (ABC) program is safe and effective. Studies have found that ABC helps parents become more responsive and makes children feel more secure and calm. Importantly, no major negative effects have been reported, indicating it is safe for families.

For the ABC plus Depression Treatment, which includes support for mothers dealing with mood and stress, similar programs have demonstrated positive results without major safety issues. These combined programs aim to help both mothers and children, and research has not shown any major risks.

Overall, these treatments aim to create a healthier family environment. Communities have successfully used them, proving they can be safely delivered outside of research settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they focus on enhancing parenting strategies while also addressing maternal mental health, a unique combination in treating both depression and disruptive behaviors. The "Attachment and Biobehavioral Catch-up" (ABC) program provides structured parenting support through 10 weekly sessions, which is a different approach compared to standard treatments like medication or individual therapy. The "Attachment and Biobehavioral Catch-up Plus Depression Treatment" (ABC+D) adds a novel element by including short weekly videos aimed at boosting mothers' mood, stress management, and coping skills, offering a dual focus on both child development and maternal wellbeing. This dual approach could lead to more comprehensive and effective results for both children and parents compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for depression and disruptive behaviors?

Research has shown that the Attachment and Biobehavioral Catch-up (ABC) program, one of the treatments in this trial, improves parenting, especially in challenging situations. One study found that ABC helped parents at high risk of mistreating their children develop better parenting skills. Another treatment arm in this trial, the ABC plus Depression Treatment (ABC+D), adds support for mothers' mood and stress, showing promise in reducing both depression in mothers and behavior problems in their children. Past programs that combined support for mothers with cognitive therapy have also helped families. Overall, these methods aim to break the cycle of depression and behavior issues in families by addressing both simultaneously. ^{3 6 7 8 9}

Who Is on the Research Team?

Danielle Roubinov, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

I have a history of psychosis or have recently planned or attempted suicide.

Child diagnosis of autism

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 weekly sessions of either ABC or ABC+D in their home, focusing on parenting support and maternal mood, stress, and coping

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in depression and behavior problems after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attachment and Biobehavioral Catch up
• Attachment and Biobehavioral Catch up Plus Depression Treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: ABC+D Experimental Treatment 1 Intervention

Attachment and Biobehavioral Catch-up plus weekly 5-10 minute videos that additional provide support for mothers' mood, stress, and coping

Group II: ABC Active Control 1 Intervention

Attachment and Biobehavioral Catch-up, 10 weekly sessions that provide parenting support

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10809929/

Integrating Treatment for Maternal Depression and Young ... In a study of family interventions for older children with disruptive behavior problems and their mothers with depression, the integration of cognitive therapy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4939064/

Community Implementation Outcomes of Attachment and ... The present study assessed whether Attachment and Biobehavioral Catch-up (ABC), an intervention for high-risk parents that has been shown to be efficacious in ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0145213415004329

Community implementation outcomes of Attachment and ... These results support the viability of ABC for enhancing parenting behavior among parents at high risk for maltreatment, and demonstrate that parent coaches in ...

5. link.springer.com link.springer.com/article/10.1007/s10488-025-01440-3

Effects of an Early Home Visiting Program on Maternal ... Maternal depression has been associated with negative parenting behaviors and poor developmental outcomes in children.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5477793/

Attachment and Biobehavioral Catch-up - PubMed Central - NIH ABC has been shown effective in enhancing parental sensitivity, and enhancing children's attachment security and regulatory capabilities. A key feature of the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6994358/

Intervening with Attachment and Biobehavioral Catch-up to ... Results indicate that 39.0% of children were classified as having a disorganized attachment at the first follow-up visit after completion of the ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/imhj.22025

The impact of the “Attachment and Biobehavioural Catch‐ ... The findings showed ABC had a significant small to medium effect on a variety of attachment related parent outcomes among parents presenting with multiple ...

9. journals.sagepub.com journals.sagepub.com/doi/10.1177/10775595241265968

Child Welfare Outcomes After Attachment and ... These outcomes can manifest in various ways, such as: physical health consequences; emotional and psychological impact; cognitive and academic; ...