- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00904917
Preventing Depression in the Children of Depressed African American Mothers
Children of Depressed Mothers: Culture & Prevention
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Abstract
Background: There is limited representation of ethnic minorities in preventive interventions for the generational impact of maternal depression.
Methods: The Preventive Intervention Project (PIP) was adapted to be culturally and contextually relevant for urban African American mothers with depression and their children. A pilot clinical trial (PIP vs. lecture) was conducted.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Yhdysvallat, 19104
- The Children's Hospital of Philadelphia
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Adapted PIP
Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project. |
Eight 1-hour sessions focused on psychoeducation, coping with stress, and cognitive-behavioral strategies.
The sessions were tailored as required to meet the clinical and cultural needs of each family; other family members, such as fathers, spouses, and grandparents, were invited to participate in the intervention.
|
Active Comparator: Lecture
Mothers received psychoeducation about depression. The intervention was psychoeducation. |
Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Children Depression Inventory (CDI)
Aikaikkuna: Measured at baseline and at post-treatment (8 weeks after baseline)
|
Children Depression Inventory (CDI; Kovacs, 1992) is a widely-used self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years.
The CDI is a 27-item scale that is self-rated and symptom-oriented.
The 27 items on the assessment are grouped into five major factor areas.
The item score are rated 0-2 with a total scores summed and converted to T scores.
The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms.
|
Measured at baseline and at post-treatment (8 weeks after baseline)
|
Multidimensional Anxiety Scale for Children (MASC)
Aikaikkuna: Measured at baseline and post-treatment (8 weeks after baseline)
|
Multidimensional Anxiety Scale for Children (MASC; March et al., 1997) is a self-report instrument that measures a broad range of anxiety symptoms in youth.
The MASC consists of 39 items using a 4-point Likert scale that are distributed across four major factors, three of which can be parsed into two subfactors each.
Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety.
Scores are summed and converted to T-scores.
The total T score ranges from 25 to 90 with higher scores representing greater levels of anxiety.
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Measured at baseline and post-treatment (8 weeks after baseline)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Understanding Mood Disorders Questionnaire (UMDQ)
Aikaikkuna: Measured at baseline and post-treatment (8 weeks after baseline)
|
Understanding Mood Disorders Questionnaire (UMDQ; Gavazzi, Fristad, & Law, 1997) measures attributions and knowledge of symptoms, course, and treatment of mood disorders and a symptom checklist.
It has 39 items and two subscales.
A range of total score is 0 to 59.
The first 20 questions are true/false questions and correct responses are scored 2 points each.
Nineteen questions are a checklist of symptoms and correct identification of those depression and manic symptoms are scored 1 point each.
All items are summed for a total score.
Higher scores indicate greater knowledge of mood disorders.
Both maternal and child reporters completed this measure.
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Measured at baseline and post-treatment (8 weeks after baseline)
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Child's Report on Parental Behavior Inventory (CRPBI)
Aikaikkuna: Measured at baseline and post-treatment (8 weeks after baseline)
|
Child's Report on Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1970) assesses children's and parents' perceptions of parental acceptance, permitting psychological autonomy, and level of parental control.
The 10-item acceptance scale which assesses parental warmth was administered.
The acceptable scale has items scored from 1 to 3 (not like me, somewhat like me, a lot like me).
Items are summed with a total range is 10 to 30.
Higher scores represents greater warmth exhibited by mother to child.
Separate forms are available for both child and parent report.
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Measured at baseline and post-treatment (8 weeks after baseline)
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Rhonda C. Boyd, PhD, Children's Hospital of Philadelphia
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2004-10-4041
- K01MH068619 (Yhdysvaltain NIH-apuraha/sopimus)
- DSIR 8K-RTCT (NIMH DSIR)
- IRB NO: 2004-10-4041 (Muu tunniste: IRB No.)
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