Preventing Depression in the Children of Depressed African American Mothers
2014年10月17日 更新者：Rhonda Boyd、Children's Hospital of Philadelphia
Children of Depressed Mothers: Culture & Prevention
The purpose of the study is to adapt and test the Preventive Intervention Project for urban African American mothers with depression and their children.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
34
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- The Children's Hospital of Philadelphia
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
8年～14年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Children Depression Inventory (CDI)
時間枠：Measured at baseline and at post-treatment (8 weeks after baseline)
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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)
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Multidimensional Anxiety Scale for Children (MASC)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Understanding Mood Disorders Questionnaire (UMDQ)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Rhonda C. Boyd, PhD、Children's Hospital of Philadelphia
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年2月1日
一次修了 (実際)
2009年2月1日
研究の完了 (実際)
2009年2月1日
試験登録日
最初に提出
2009年5月19日
QC基準を満たした最初の提出物
2009年5月19日
最初の投稿 (見積もり)
2009年5月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年10月20日
QC基準を満たした最後の更新が送信されました
2014年10月17日
最終確認日
2014年10月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2004-10-4041
- K01MH068619 (米国 NIH グラント/契約)
- DSIR 8K-RTCT (NIMH DSIR)
- IRB NO: 2004-10-4041 (その他の識別子：IRB No.)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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Virginia Commonwealth UniversityHenrico County Public Schools; Virginia Department of Aging and Rehabilitative Services; Chesterfield...完了