Facilitating Treatment Entry and Family Planning in Substance-using Neonatal Intensive Care Unit (NICU) Mothers
2020年11月17日 更新者：Angela L Stotts、The University of Texas Health Science Center, Houston
Facilitating Treatment Entry and Family Planning in Substance-using NICU Mothers
The purpose of this pilot study is to assess whether the hospital-based, adaptive behavioral intervention strategy promotes treatment entry and reduces risk of additional substance-exposed pregnancies (SEPs), as well as HIV and Hepatitis C Virus (HCV) risks among substance-using NICU mothers.
Additionally, to assess whether the intervention increases use of professional obstetrical/gynecological resources for contraception to reduce substance-exposed pregnancies (SEPs).
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
64
段階
- 適用できない
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
-
-
Texas
-
Houston、Texas、アメリカ、77030
- The University of Texas Health Science Center at Houston
-
-
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
18年歳以上 (大人、高齢者)
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
女性
説明
Inclusion Criteria:
- have an infant in the NICU at Children's Memorial Hermann Hospital (CMHH)
- have a positive urine drug screen at delivery or have an infant with a positive urine or meconium drug screen or self-reported drug use to a healthcare provider or had a documented positive drug screen during pregnancy
- have access to a telephone.
Exclusion Criteria:
- currently attending substance abuse treatment
- severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
- inability to read, write, speak English or Spanish
- inability or unwillingness to provide signed consent for participation; (5) inability or unwillingness to meet study requirements.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：MI and ACT
Participants will receive behavioral therapy including Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
|
Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
|
|
アクティブコンパレータ：Conventional Care
Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.
|
Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.
|
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 |
|---|---|---|
|
Treatment Entry
時間枠：8 weeks
|
Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor
|
8 weeks
|
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
時間枠：2 months
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
|
2 months
|
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
時間枠：6 months
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
|
6 months
|
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
時間枠：2 months
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
|
2 months
|
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
時間枠：6 months
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
時間枠：2 months
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
|
2 months
|
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
時間枠：6 months
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
|
6 months
|
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
時間枠：2 months
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
|
2 months
|
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
時間枠：6 months
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
|
6 months
|
|
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
時間枠：2 months
|
This self-report measure of psychological flexibility will assess a participant's willingness to have undesirable thoughts and feelings related to drug use while still pursuing self-identified goals.
This version of the AAQ was specifically developed for substance-abusing populations.
|
2 months
|
|
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
時間枠：6 months
|
This self-report measure of psychological flexibility will assess a participant's willingness to have undesirable thoughts and feelings related to drug use while still pursuing self-identified goals.
This version of the AAQ was specifically developed for substance-abusing populations.
|
6 months
|
|
Number of participants whose infant had routine follow-up pediatric appointments
時間枠：6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant had routine follow-up pediatric appointments.
|
6 months
|
|
Number of participants whose infant had acute care visits
時間枠：6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant had acute care visits.
|
6 months
|
|
Number of participants whose infant had emergency department visits
時間枠：6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant had emergency department visits.
|
6 months
|
|
Number of participants whose infant was re-hospitalized
時間枠：6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant was re-hospitalized.
|
6 months
|
|
Number of participants who lost custody of the infant
時間枠：6 months
|
Medical records will be used, with participant consent, and additionally the research team will collaborate with the NICU social worker and the assigned child protective services (CPS) caseworker, with participant consent, to obtain information about the number of participants who lost custody of the infant.
|
6 months
|
|
Number of participants for which any additional abuse or neglect complaints were filed after baseline
時間枠：6 months
|
Medical records will be used, with participant consent, and additionally the research team will collaborate with the NICU social worker and the assigned child protective services (CPS) caseworker, with participant consent, to obtain information about the number of participants for which any additional abuse or neglect complaints were filed after baseline.
|
6 months
|
|
Drug use
時間枠：2 months
|
Number of participant who test positive for drug use as assessed by urine drug screen
|
2 months
|
|
Drug use
時間枠：6 months
|
Number of participant who test positive for drug use as assessed by urine drug screen
|
6 months
|
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：Angela Stotts, PhD、The University of Texas Health Science Center, Houston
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 (実際)
2017年7月5日
一次修了 (実際)
2020年1月3日
研究の完了 (実際)
2020年1月3日
試験登録日
最初に提出
2017年5月23日
QC基準を満たした最初の提出物
2017年5月23日
最初の投稿 (実際)
2017年5月24日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月19日
QC基準を満たした最後の更新が送信されました
2020年11月17日
最終確認日
2020年11月1日
詳しくは
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。