- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00904917
Preventing Depression in the Children of Depressed African American Mothers
Children of Depressed Mothers: Culture & Prevention
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- The Children's Hospital of Philadelphia
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Children Depression Inventory (CDI)
Časové okno: 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.
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Measured at baseline and at post-treatment (8 weeks after baseline)
|
Multidimensional Anxiety Scale for Children (MASC)
Časové okno: 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)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Understanding Mood Disorders Questionnaire (UMDQ)
Časové okno: Measured at baseline and post-treatment (8 weeks after baseline)
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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)
Časové okno: Measured at baseline and post-treatment (8 weeks after baseline)
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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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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Rhonda C. Boyd, PhD, Children's Hospital of Philadelphia
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2004-10-4041
- K01MH068619 (Grant/smlouva NIH USA)
- DSIR 8K-RTCT (NIMH DSIR)
- IRB NO: 2004-10-4041 (Jiný identifikátor: IRB No.)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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