University of California, San Francisco
San Francisco, California, 94118, United States
NCT Number: NCT05096611
Maternal depression influences the development of children's behavior problems and vice versa; however most interventions singularly address maternal depression or children's behavior problems rather than both. This project assesses the efficacy of an intervention that treats both mothers and children in an integrated manner. Effects are expected to disrupt the reciprocal relations that perpetuate maternal and child mental health problems over time.
Looking for future studies?
Notify Me2 year and older
Female
Interventional
Not applicable
San Francisco, California, 94118, United States
The proposed project is a pilot randomized controlled trial to evaluate the effectiveness of an integrated intervention that dually treats maternal depressive symptoms and offspring behavior problems. Families (n = 40 mothers and their 2-to-4 year-old children) will be randomized to receive 10 sessions of ABC or 10 sessions of ABC+D in their home. ABC+D is an expanded version of ABC that additionally treats maternal depressive symptoms using Mothers and Babies adapted for mothers of toddlers. The specific aims of this proposed project are:
Aim 1. Collect preliminary data on the feasibility and acceptability of ABC+D in preparation for a small pilot randomized controlled trial (RCT).
Aim 2. Conduct a small pilot RCT to examine the effectiveness of ABC and ABC+D
Aim 3: Assess the overall acceptability (mother- and provider-rated), appropriateness (mother- and provider-rated), and feasibility (provider-rated) of ABC+D. Mothers will also rate their satisfaction with each session and the degree to which it was helpful, interesting, and comprehensible.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ABC is delivered by a trained parent coach. The parent coach provides information about parenting and child development. The focus is on providing support for parents of young children and improving the parent-child relationship.
Other names: ABC
ABC+D offers the same 10-sessions of parenting support that is provided by ABC and additionally provides weekly short videos that help mothers develop skills for coping with stress and regulating mood.
Other names: ABC+D
Time frame: Baseline to post-intervention. This is approximately 10 weeks.
Scores range from 34.5 to 82.3 with higher values indicating more severe symptoms
Time frame: Baseline to post-intervention. This is approximately 10 weeks.
Scores range from 0 to 80 with higher values indicating more severe symptoms
University of California, San Francisco
Other
Efficacy of an Integrated Intervention to Treat Maternal Depression and Children's Behavior Problems: A Transactional Perspective
Acronym: ABC+D
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05959538
Behavior, Child Development
Winnipeg, Manitoba, Canada
View Trial DetailsNCT04639557
Child Development, Child Mental Health
Winnipeg, Manitoba, Canada
View Trial DetailsNCT01326182
Asthma, Behavior
Providence, Rhode Island, United States
View Trial DetailsNCT02526355
Maternal Depression
Lahore, Punjab Province, Pakistan
View Trial Details