Early Intervention Programs for Adolescent Mental Health

(SCOH-A Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores early intervention programs to support mental health in children as they grow into adolescents. It specifically examines two treatments: Attachment and Biobehavioral Catch-up (ABC), which improves parental nurturing, and Developmental Education for Families (DEF), which enhances cognitive development. The goal is to determine how these early interventions can positively impact mental health in the long term. Participants should have already taken part in the study's middle childhood data collection. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could shape future mental health interventions for children.

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.

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

A previous study found the Attachment and Biobehavioral Catch-up (ABC) program safe for children. This program includes 10 sessions that guide parents in caring for and responding to their children supportively. Research shows no major problems were reported during the study, indicating it is well-tolerated by participants.

Specific safety data for the Developmental Education for Families (DEF) program is not available. However, it focuses on enhancing children's learning and has been widely used in various settings to support family education, suggesting it is generally considered safe.

Overall, evidence suggests that both the ABC and DEF programs do not pose significant safety risks. Since the trial is in an early phase, ensuring safety remains a top priority, and any issues will be closely monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for adolescent mental health because they focus on early intervention through family involvement, which is different from the typical medication or therapy sessions. The Attachment and Biobehavioral Catch-up (ABC) program emphasizes enhancing parental nurturance and sensitivity in just 10 sessions, potentially fostering stronger emotional bonds and resilience in adolescents. Meanwhile, the Developmental Education for Families (DEF) program targets cognitive development, aiming to improve mental health outcomes by equipping families with practical developmental strategies. These approaches offer a fresh perspective by actively involving families in the therapeutic process, potentially leading to more sustainable mental health improvements.

What evidence suggests that this trial's treatments could be effective for adolescent mental health?

This trial will compare the Attachment and Biobehavioral Catch-up (ABC) program with the Developmental Education for Families (DEF) program. Research shows that the ABC program helps children manage their emotions better and reduces difficult behaviors. Specifically, studies have found that children who participated in ABC demonstrated better long-term control over their emotions and behavior.

For the DEF program, evidence suggests it enhances children's thinking skills and reduces mental health issues. Positive outcomes were observed, with noticeable drops in mental and behavioral health problems. Both programs aim to support children and families, providing lasting benefits for mental and emotional well-being. ^{2 4 6 7 8}

Who Is on the Research Team?

Mary Dozier, PhD

Principal Investigator

University of Delaware

Are You a Good Fit for This Trial?

This trial is for adolescents who were previously part of an early childhood study and participated in middle childhood data collection. There are no specific exclusion criteria, so all those from the earlier phase can join.

Inclusion Criteria

Must have been included in middle childhood data collection

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents participate in 10 sessions focusing on parental nurturance and sensitivity (ABC) or cognitive development (DEF)

10 sessions

Adolescent Assessment

Behavioral and neurobiological development assessed among adolescents aged 13-15 years

3 years

Annual assessments

Follow-up

Participants are monitored for long-term outcomes related to mental health and behavioral regulation

1-2 years

What Are the Treatments Tested in This Trial?

Interventions

• Attachment and Biobehavioral Catch-up (ABC)
• Developmental Education for Families (DEF)

Trial Overview The study tests two interventions: Attachment and Biobehavioral Catch-up (ABC) and Developmental Education for Families (DEF), which were first introduced in infancy to see their long-term effects on depression, anxiety, and conduct disorders.

How Is the Trial Designed?

Group I: Attachment and Biobehavioral Catch-up (ABC) Experimental Treatment 1 Intervention

10 sessions that focused on parental nurturance, and sensitivity

Group II: Developmental Education for Families (DEF) Active Control 1 Intervention

10 sessions that focused on cognitive development

Attachment and Biobehavioral Catch-up (ABC) is already approved in United States for the following indications:

Approved in United States as Attachment and Biobehavioral Catch-up for:

• Parenting support for children aged 0-48 months
• Stress reduction in children
• Improvement of child-caregiver attachment

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

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

Attachment and Biobehavioral Catch-up - PubMed Central - NIH Attachment and Biobehavioral Catch-up (ABC) is a 10-session home program to enhance parental sensitivity, targeting inadequate or problematic caregiving.

2. massaimh.org massaimh.org/wp-content/uploads/2020/02/Chapter31AttachmentAndBiobehavior.pdf

Attachment and Biobehavioral Catch-Up ABC is a 10-session parenting intervention focusing on nurturing, following the child's lead, and avoiding harsh behavior, delivered in parents' homes.

3. researchgate.net researchgate.net/publication/328545291_ATTACHMENT_AND_BIOBEHAVIORAL_CATCH-UP_A_SYSTEMATIC_REVIEW_ABS_A_Systematic_Review

(PDF) ATTACHMENT AND BIOBEHAVIORAL CATCH-UP Findings indicate that ABC is effective, when implemented with child-welfare-involved children, at improving emotion regulation, improving ...

4. apadivisions.org apadivisions.org/division-7/publications/newsletters/developmental/2019/01/biobehavioral-intervention

The Attachment and Biobehavioral Catch-Up (ABC) Intervention We have assessed the efficacy of the ABC intervention through randomized, controlled trials and found striking and lasting effects on children's ...

5. homvee.acf.gov homvee.acf.gov/models/attachment-and-biobehavioral-catch-abc-infant

Attachment and Biobehavioral Catch-Up (ABC) -Infant A finding showing a statistically significant impact on an outcome measure in a direction that is beneficial for children and parents. No effect: Findings ...

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

Intervening with Attachment and Biobehavioral Catch-up to ... This randomized controlled trial investigated the efficacy of Attachment and Biobehavioral Catch-up (ABC; Dozier, Bick, & Bernard, 2011) in reducing disrupted ...

7. abcparenting.org abcparenting.org/

ABC Parenting Institute: Welcome ABC Parenting Institute is a non-profit organization that partners with communities to implement the Attachment and Biobehavioral Catch-up (ABC) intervention.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8535762/

Intervening With Attachment and Biobehavioral Catch-Up ... The current study assessed the efficacy of the Attachment and Biobehavioral Catch-up intervention (ABC; Dozier & Bernard, 2019) for reducing behavior problems ...