N/A N=368 Randomized Double-blind Treatment

Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development

Maternal Depression and Parent Practices, Postpartum · Infant Development

Bottom Line

View on ClinicalTrials.gov: NCT03464630 ↗

Enrolled (actual)

368

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcome: Primary: PHQ9 — 11.94; 10.31; 5.61; 5.33 score on a scale — p=0.503

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mom & Baby Net (Behavioral); Depression & Developmental Awareness System (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Georgia State University
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY PHQ9	11.94; 10.31; 5.61; 5.33	0.503
PRIMARY Landry Parent Child Interaction Rating Scales - Mother Positive Behavior	12.43; 13.16; 15.54; 13.04	<0.001 sig
PRIMARY Landry Parent Child Interaction Rating Scales - Mother Negative Behavior	0.27; 0.25; 0.21; 0.38	0.059
PRIMARY Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior	5.21; 4.97; 6.35; 5.92	0.702
PRIMARY Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend	1.92; 3.45; 5.83; 3.66	0.08
PRIMARY Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive	29.79; 30.39; 39.47; 33.54	0.09
PRIMARY Indicator of Parent Child Interaction (IPCI) - Child Positive Social	16.50; 14.82; 27.96; 25.81	0.898
PRIMARY Indicator of Parent Child Interaction (IPCI) - Child Engagement	31.14; 32.70; 42.44; 40.56	0.349
PRIMARY Knowledge of Infant Social-Emotional Development and Promotion	8.62; 8.01; 14.66; 8.54	<0.001 sig

Summary

A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes

Eligibility Criteria

Inclusion Criteria

Mother is 18 years of age
Mother speaks English
Mother lives in metro-Atlanta area
Mother has baby younger than 12 months of age
Mother has positive depression screen (PHQ2)

Exclusion Criteria

Stressors that mother specifies at the time of screening that would interfere with study participation such as: maternal homelessness, mental or physical health condition (diagnosed with schizophrenia or treatment/medication for hallucinations/delusions), current inpatient treatment for mental health or substance abuse. Infant exclusion criteria include factors that could render research participation stressful, such as intensive treatment for a genetic or health condition or not in permanent legal guardian custody

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03464630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.