Longitudinal, Multi-Dimensional Assessment of Recovery and Added Benefit of a Behavioral Health Intervention for Children With Abusive Head Trauma
2020年9月8日 更新者：University of Colorado, Denver
Family dynamics and caregiver responses to a child with traumatic brain injury are implicated both as precipitating events as well as factors influencing outcomes of abusive head trauma (AHT).
However, no family behavioral health intervention exists to meet the unique needs of families with infants and very young children with AHT.
The study was initially designed as a randomized controlled trial (RCT) to assess the efficacy of an evidence-based behavioral intervention to improve outcomes for families and children with AHT.
However, rates of recruitment were so low that the investigators and funder amended the study to be intervention only (with IRB approval).
At that time, there were five participants and only one had been assigned to the intervention arm.
Only one additional family was recruited, and that family did not complete study measures prior to the time at which the intervention would start and did not receive the intervention.
The investigators did examine outcomes in multiple dimensions, including clinical, cognitive, family, caregiver, child behavior, and service usage over time but connot compare to patients not receiving the intervention.
The investigators were not able to examine characteristics of patients and families best suited for this behavioral health intervention.
調査の概要
詳細な説明
27 children (ages 3 months to 2 years) and their caregiver referred to the Non-Accidental Brain Injury Care Clinic at the Children's Hospital Colorado (CHCO) were recruited for participation in the study, 7 families consented.
One family received the Attachment and Biobehavioral (ABC) intervention.
One family discontinued participation.
The data collection schedule was 1 month post-injury, 3 months, 6 months, 9 months, and 12 months.
Outcomes in multiple dimensions, were assessed including clinical recovery, cognitive, language, and motor functioning, family functioning, caregiver mental health including anxiety, depression, competency, and stress.
The investigators also examined service use over time.
Analyses will assess trajectories of recovery for both groups using data for all time points.
研究の種類
介入
入学 (実際)
7
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
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- Children's Hospital of Colorado
-
-
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
3ヶ月～2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
Inclusion Criteria:
- Children who have experienced AHT as determined by the CHCO Child Protection Team
- Caregivers who speak English
- Families who live in the Denver Metro area and,
- Child-victim age between 3 months and 2 years of age
Exclusion Criteria:
- Those with significant disability that would inhibit participation in the intervention,
- Those scoring below 6 months on developmental measures will not be eligible.
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：支持療法
- 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 |
|---|---|
|
実験的：ABC Intervention
The investigators will deliver the "Attachment and Biobehavioral Catch-up (ABC)" in the home weekly using live, in-room coaching, to give caregivers feedback as they use targeted skills during interactions with the child.
The intervention will last 10 sessions.
Study participants in both groups will complete study measures at baseline, 1 month, 3 months, post-intervention, 6 months, and 12 months.
|
Attachment and Biobehavioral Catch-up (ABC) is an in-home, 10-session, manualized parent-training program for children ages 6 months through 2 years who have experienced early adversity.
ABC utilizes parent-child interactions to enhance positive interactions with the child through live coaching with particular focus on nurturing behaviors, following the child's lead, non-frightening behaviors.
These behaviors include appropriate soothing and comforting when a child is distressed, responding to or imitating a child in a contingent way, and displaying warmth.
|
|
介入なし：Standard of Care
Subjects will receive normal standard of care without the "Attachment and Biobehavioral Catch-up (ABC)".
|
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 |
|---|---|---|
|
Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care.
時間枠：6 months
|
Compare the Cognitive scale standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The cognitive scale standard score ranges from 50-150.
Higher scores indicate better cognitive functioning.
|
6 months
|
|
Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care.
時間枠：6 months
|
Compare the overall Motor standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The overall Motor score is a combined score from the Gross Motor and Fine Motor Scales of the Bayley III.
The overall motor score is a summed value from the Gross Motor and Fine Motor subscales.
Subscale scores are added, then standardized (Mean = 100, SD =15).
The range of values for the overall Motor standard score is 50-150.
Higher values indicate better motor functioning.
|
6 months
|
|
Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual.
時間枠：6 months
|
Compare scores from the Social-Emotional standard score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The range of values for the Social-Emotional Scale is 50-150.
Higher values indicate better social-emotional functioning.
|
6 months
|
|
Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual.
時間枠：6 months
|
Compare scores on the overall language score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The overall language score is the summed score from the Expressive Language and Receptive Language subscales.
The summed value is then standardized (mean = 100, SD = 15).
The range of values are 50-150.
Higher values indicate better language functioning.
|
6 months
|
|
Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：6 months
|
Compare caregiver depression scores of those receiving the intervention to those receiving care as usual.
Depression is measured using the Center for Epidemiological Depression Scale (CES-D).
Values range from 0-60.
Higher values indicate greater depressive symptoms.
|
6 months
|
|
Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：6 months
|
Compare caregiver scores from the Generalized Anxiety scale (GAD) of those receiving the intervention to those receiving care as usual.
The range of values is 0 -21.
Higher values indicate greater anxiety symptoms.
|
6 months
|
|
Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：6 months
|
Compare scores on the Parenting Stress Index-Short Form of those receiving the intervention to those receiving care as usual.
Scores on the PSI-SF are a sum of scores from non-duplicate items from the Parental Distress subscale, Parent-child dysfunctional interaction subscale, and the difficult child subscale.
Range of values for the total score are 36-180.
Higher values indicate greater parental distress.
|
6 months
|
|
Evaluation of family functioning of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：6 months
|
Compare scores from the General Functioning subscale of the Family Assessment Device of those receiving the intervention to those receiving care as usual.
Scores on the General Functioning subscale range from 12 to 48.
Higher values indicate greater family dysfunction.
|
6 months
|
|
Evaluation of screener scores of child abuse risk of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：6 months
|
Compare scores on the Child Abuse Potential Inventory -Brief Version of caregivers receiving the intervention to those receiving care as usual.
Scores on the brief version range from 0-34.
Higher scores indicate greater potential risk of child abuse.
|
6 months
|
|
Evaluation of caregiver reported service utilization for children receiving the ABC intervention to those receiving care as usual.
時間枠：6 months
|
Compare the utilization of occupational, physical, speech, vision, feeding, or developmental therapy, as well as receipt of nursing care and family psychological services of those families receiving the intervention compared to those receiving care as usual.
Service utilization is captured through a project developed measure asking the respondent if his/her child received any service on the list of services since the last interview period.
Any endorsement of any service will be coded affirmative.
Indicators of use of those receiving the intervention will be compare to those receiving care as usual.
|
6 months
|
|
Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care.
時間枠：9 months
|
Compare the Cognitive scale standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The cognitive scale standard score ranges from 50-150.
Higher scores indicate better cognitive functioning.
|
9 months
|
|
Evaluation of cognitive scores of children receiving the ABC intervention to those receiving usual care.
時間枠：12 months
|
Compare the Cognitive scale standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The cognitive scale standard score ranges from 50-150.
Higher scores indicate better cognitive functioning.
|
12 months
|
|
Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care.
時間枠：9 months
|
Compare the overall Motor standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The overall Motor score is a combined score from the Gross Motor and Fine Motor Scales of the Bayley III.
The overall motor score is a summed value from the Gross Motor and Fine Motor subscales.
Subscale scores are added, then standardized (Mean = 100, SD =15).
The range of values for the overall Motor standard score is 50-150.
Higher values indicate better motor functioning.
|
9 months
|
|
Evaluation of motor scores of children receiving the ABC intervention to those receiving usual care.
時間枠：12 months
|
Compare the overall Motor standard score from the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The overall Motor score is a combined score from the Gross Motor and Fine Motor Scales of the Bayley III.
The overall motor score is a summed value from the Gross Motor and Fine Motor subscales.
Subscale scores are added, then standardized (Mean = 100, SD =15).
The range of values for the overall Motor standard score is 50-150.
Higher values indicate better motor functioning.
|
12 months
|
|
Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual.
時間枠：9 months
|
Compare scores from the Social-Emotional standard score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The range of values for the Social-Emotional Scale is 50-150.
Higher values indicate better social-emotional functioning.
|
9 months
|
|
Evaluation of socioemotional scores of children receiving the ABC intervention to those receiving care as usual.
時間枠：12 months
|
Compare scores from the Social-Emotional standard score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The range of values for the Social-Emotional Scale is 50-150.
Higher values indicate better social-emotional functioning.
|
12 months
|
|
Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual.
時間枠：9 months
|
Compare scores on the overall language score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The overall language score is the summed score from the Expressive Language and Receptive Language subscales.
The summed value is then standardized (mean = 100, SD = 15).
The range of values are 50-150.
Higher values indicate better language functioning.
|
9 months
|
|
Evaluation of language scores of children receiving the ABC intervention to those receiving care as usual.
時間枠：12 months
|
Compare scores on the overall language score on the Bayley Scales of Infant and Toddler Development-Third Edition of those receiving the intervention to those receiving care as usual.
The overall language score is the summed score from the Expressive Language and Receptive Language subscales.
The summed value is then standardized (mean = 100, SD = 15).
The range of values are 50-150.
Higher values indicate better language functioning.
|
12 months
|
|
Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：9 months
|
Compare caregiver depression scores of those receiving the intervention to those receiving care as usual.
Depression is measured using the Center for Epidemiological Depression Scale (CES-D).
Values range from 0-60.
Higher values indicate greater depressive symptoms.
|
9 months
|
|
Evaluation of depression scores of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：12 months
|
Compare caregiver depression scores of those receiving the intervention to those receiving care as usual.
Depression is measured using the Center for Epidemiological Depression Scale (CES-D).
Values range from 0-60.
Higher values indicate greater depressive symptoms.
|
12 months
|
|
Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：9 months
|
Compare caregiver scores from the Generalized Anxiety scale (GAD) of those receiving the intervention to those receiving care as usual.
The range of values is 0 -21.
Higher values indicate greater anxiety symptoms.
|
9 months
|
|
Evaluation of anxiety scores of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：12 months
|
Compare caregiver scores from the Generalized Anxiety scale (GAD) of those receiving the intervention to those receiving care as usual.
The range of values is 0 -21.
Higher values indicate greater anxiety symptoms.
|
12 months
|
|
Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：9 months
|
Compare scores on the Parenting Stress Index-Short Form of those receiving the intervention to those receiving care as usual.
Scores on the PSI-SF are a sum of scores from non-duplicate items from the Parental Distress subscale, Parent-child dysfunctional interaction subscale, and the difficult child subscale.
Range of values for the total score are 36-180.
Higher values indicate greater parental distress.
|
9 months
|
|
Evaluation of parenting stress scores of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：12 months
|
Compare scores on the Parenting Stress Index-Short Form of those receiving the intervention to those receiving care as usual.
Scores on the PSI-SF are a sum of scores from non-duplicate items from the Parental Distress subscale, Parent-child dysfunctional interaction subscale, and the difficult child subscale.
Range of values for the total score are 36-180.
Higher values indicate greater parental distress.
|
12 months
|
|
Evaluation of family functioning of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：9 months
|
Compare scores from the General Functioning subscale of the Family Assessment Device of those receiving the intervention to those receiving care as usual.
Scores on the General Functioning subscale range from 12 to 48.
Higher values indicate greater family dysfunction.
|
9 months
|
|
Evaluation of family functioning of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：12 months
|
Compare scores from the General Functioning subscale of the Family Assessment Device of those receiving the intervention to those receiving care as usual.
Scores on the General Functioning subscale range from 12 to 48.
Higher values indicate greater family dysfunction.
|
12 months
|
|
Evaluation of screener scores of child abuse risk of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：9 months
|
Compare scores on the Child Abuse Potential Inventory -Brief Version of caregivers receiving the intervention to those receiving care as usual.
Scores on the brief version range from 0-34.
Higher scores indicate greater potential risk of child abuse.
|
9 months
|
|
Evaluation of screener scores of child abuse risk of caregivers receiving the ABC intervention to those receiving care as usual.
時間枠：12 months
|
Compare scores on the Child Abuse Potential Inventory -Brief Version of caregivers receiving the intervention to those receiving care as usual.
Scores on the brief version range from 0-34.
Higher scores indicate greater potential risk of child abuse.
|
12 months
|
|
Evaluation of caregiver reported service utilization for children receiving the ABC intervention to those receiving care as usual.
時間枠：9 months
|
Compare the utilization of occupational, physical, speech, vision, feeding, or developmental therapy, as well as receipt of nursing care and family psychological services of those families receiving the intervention compared to those receiving care as usual.
Service utilization is captured through a project developed measure asking the respondent if his/her child received any service on the list of services since the last interview period.
Any endorsement of any service will be coded affirmative.
Indicators of use of those receiving the intervention will be compare to those receiving care as usual.
|
9 months
|
|
Evaluation of caregiver reported service utilization for children receiving the ABC intervention to those receiving care as usual.
時間枠：12 months
|
Compare the utilization of occupational, physical, speech, vision, feeding, or developmental therapy, as well as receipt of nursing care and family psychological services of those families receiving the intervention compared to those receiving care as usual.
Service utilization is captured through a project developed measure asking the respondent if his/her child received any service on the list of services since the last interview period.
Any endorsement of any service will be coded affirmative.
Indicators of use of those receiving the intervention will be compare to those receiving care as usual.
|
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluation clusters of patient and family characteristics that benefit most from a parenting intervention component
時間枠：1 month, 3 month, 6 months, 9 months, 12 months
|
Compare any changes in Demographic, family, and injury data aggregated in a latent class approach to identify which constellations of risk and protective factors were most amenable to the intervention.
|
1 month, 3 month, 6 months, 9 months, 12 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：Terri H Lewis, PhD、University of Colorado, Denver
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)
2018年4月1日
一次修了 (実際)
2020年6月30日
研究の完了 (実際)
2020年6月30日
試験登録日
最初に提出
2018年1月10日
QC基準を満たした最初の提出物
2018年2月26日
最初の投稿 (実際)
2018年2月27日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月10日
QC基準を満たした最後の更新が送信されました
2020年9月8日
最終確認日
2020年9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。