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Attachment and Biobehavioral Catch-up for Depression (ABC)

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ClinicalTrials.gov Identifier: NCT04050202
Recruitment Status : Active, not recruiting
First Posted : August 8, 2019
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Anxiety Symptoms Behavioral: Attachment and Biobehavioral Catch-up (ABC) Intervention Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Attachment and Biobehavioral Catch-up for Depression Intervention
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABC
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.
Behavioral: Attachment 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.
Other Name: ABC




Primary Outcome Measures :
  1. Change in Child Behavior Checklist Internalizing Scale score [ Time Frame: Baseline to post-intervention, an anticipated average of 10 weeks ]
    T-scores range from 29 to 100 with higher values indicating more severe symptoms

  2. Change in Center for Epidemiologic Studies Depression Scale score [ Time Frame: Baseline to post-intervention, an anticipated average of 10 weeks ]
    Scores range from 0 to 60 with higher values indicating more severe symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050202


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94107
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Danielle Roubinov, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04050202    
Other Study ID Numbers: A130886
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms