Phase 1
N=34
Preventing Depression in the Children of Depressed African American Mothers
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00904917 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Children Depression Inventory (CDI) — 47.64; 47.00; 42.11; 43.83 T scores — p=.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Prevention Intervention Project (Behavioral); Psychoeducation (Behavioral)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children Depression Inventory (CDI) |
47.64; 47.00; 42.11; 43.83 | .015 sig |
| PRIMARY Multidimensional Anxiety Scale for Children (MASC) |
50.64; 52.50; 43.67; 57.67 | — |
| SECONDARY Understanding Mood Disorders Questionnaire (UMDQ) |
23.86; 14.70; 24.25; 13.13; 22.80; 14.67 | .037 sig |
| SECONDARY Child's Report on Parental Behavior Inventory (CRPBI) |
25.57; 24.55; 24.88; 27.13; 26.40; 24.67 | — |
Summary
The purpose of the study is to adapt and test the Preventive Intervention Project for urban African American mothers with depression and their children.
Eligibility Criteria
Mothers:
Inclusion Criteria
- African American
- Primary current or past-year diagnostic and statistical manual (DSM-IV) diagnosis of Major Depressive Disorder, Dysthymic Disorder, or Depressive Disorder not otherwise specified
- Parent or guardian and primary caregiver of a child 8 to 14 years old
- Resided at least part time for the past year with the targeted child
- May be receiving psychopharmacological treatment, psychosocial services, or both
Exclusion Criteria
- Current or lifetime history of schizophrenia
- Current or lifetime history of bipolar disorder
- Current or past-year diagnosis of alcohol or drug dependency
- Serious medical disorder, neurological disorder, condition, or chronic pain that prevents participation
- Documented mental retardation
- Current suicide risk sufficient to preclude outpatient treatment
Children:
Inclusion Criteria
- Have an African American mother with a depressive disorder
- 8 to 14 years old
- Reside at least part time with mother
Exclusion Criteria
- Currently in treatment for depression or an anxiety disorder
- Presence of a medical or psychiatric condition contraindicating study intervention, such as mental retardation, suicidality, or pervasive developmental disorder
Data sourced from ClinicalTrials.gov (NCT00904917). 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.