A Pilot Efficacy and Implementation Study of the Strengths Intervention Project (SIP)
2019년 10월 14일 업데이트: Children's Hospital of Philadelphia
The purpose of this study is to test a strengths-based intervention to be delivered in a primary care setting with adolescents and a parent.
Investigators want to find out if the intervention can help parents and teens communicate.
Specifically Investigators want to see if they can help parents and teens identify and build teen's strengths.
Half the dyads will receive the educational materials in conjunction with their teen's well-child visit, while the other half will receive usual care at the well-child visit and receive the educational materials at the end of the study.
Additionally, Investigators expect that a strengths-based intervention may also impact adherence to treatment in youth with a chronic illness.
As such, Investigators will include a subgroup of teenagers diagnosed with asthma in this study, to assess whether the strengths-based intervention that the Investigators developed has an impact on adherence.
연구 개요
상세 설명
Recent research suggests that parents and adolescents report an interest in doctors facilitating increased parent-teen communication about teen strengths. However, little research focuses on how to address this need in a primary care setting. Content from subject matter experts along with data gathered from parents and teens were used to develop a novel strengths-based intervention to be tested in primary care.
The study intervention being examined is called the Strengths Intervention Project and includes a written pamphlet, a guided discussion activity, in-person/phone health coaching, and in-person or mailed health care provider endorsement and key messaging. Measures will be collected at baseline pre-intervention (T1), in clinic or over the phone at the time of the intervention (T2), approximately two weeks post-intervention (T3), and approximately 2 months post-intervention (T4). Daily diaries will also be utilized twice to gather data pre- and post- intervention. We will measure feasibility of clinic implementation of intervention, as well as influence of intervention on parent-teen communication and adolescent outcomes.
연구 유형
중재적
등록 (실제)
174
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- The Children's Hospital of Philadelphia
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
13년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Adolescent Criteria:
Inclusion Criteria:
- Teens age 13 to 15 years at the time of their upcoming well-child visit (Arm 1) OR Teens age 13 to 15 years at the time of their last well-child visit (Arm 2)
- Children's Hospital of Philadelphia (CHOP) primary care patient (Arm 1 and 2)
- Scheduled for a well-child visit that parent and teen both plan to attend (Arm 1) OR Attended a well-child visit with parent (Arm 2)
- Diagnosed with Asthma > year (asthma subgroup; Arm 1 only)
- Prescribed a controller medication year-round (asthma subgroup; Arm 1 only)
- Adolescent has their own email account to complete electronic surveys (Arm 1 and 2)
Exclusion Criteria:
- Not fluent in written or spoken English (Arm 1 and 2)
- Attending a new patient well-child visit (Arm 1) OR attended a new patient well-child visit (Arm 2)
- Presence of developmental delay or pervasive developmental disorder that requires special education services (Arm 1 and 2)
- Psychiatric hospitalization of the adolescent in the past year (Arm 1 and 2)
- Participated in studies: CHOP IRB # 15-011732 and/or CHOP IRB # 17-013895 (Arm 1 and 2)
- Adolescent has sibling enrolled in (IRB 18-014922) (Arm 1 and 2)
Parent Criteria:
Inclusion Criteria:
- Parent or legal guardian of a teen age 13 to 15 years at their upcoming well-child visit at a CHOP primary care practice (Arm 1) OR Parent or legal guardian of a teen age 13 to 15 years at their recent well-child visit at a CHOP primary care practice (Arm 2)
- Parent has their own email account to complete electronic surveys (Arm 1 and 2)
Exclusion Criteria:
- Not fluent in written or spoken English (Arm 1 and 2)
- Participated in studies: CHOP IRB # 15-011732 and/or CHOP IRB # 17-013895 (Arm 1 and 2)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention Group (Arm 1- Main)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
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This is a clinic based psychoeducational intervention for adolescent patients and their parents to improve parent-teen communication about teen strengths.
The intervention is designed, if possible, to coincide with the adolescent patients' well-child visits and consists of the following components: (1) In-person or over the phone orientation session with a trained health coach and parent, (2) Distribution of psychoeducational materials to the parent, (3) Endorsement and delivery of key messages from the health care provider, and (4) "Booster" phone call placed by the health coach.
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간섭 없음: Control Group (Arm 1- Main)
Will receive usual care at well-child visit.
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실험적: Intervention Group (Arm 1-asthma subgroup)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
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This is a clinic based psychoeducational intervention for adolescent patients and their parents to improve parent-teen communication about teen strengths.
The intervention is designed, if possible, to coincide with the adolescent patients' well-child visits and consists of the following components: (1) In-person or over the phone orientation session with a trained health coach and parent, (2) Distribution of psychoeducational materials to the parent, (3) Endorsement and delivery of key messages from the health care provider, and (4) "Booster" phone call placed by the health coach.
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간섭 없음: Control Group (Arm 1-asthma subgroup)
Will receive usual care at well-child visit.
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간섭 없음: Control Group (Arm 2)
Convenience sample used for a post-hoc, exploratory analysis.
Will receive usual care at well-child visit.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Beliefs about Adolescents
기간: Baseline (T1) and 2-months (T4)
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26 items (parents only); Likert scale (1= very unlikely; 7= very, very likely)
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Baseline (T1) and 2-months (T4)
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Change in Parent-Adolescent Communication (PACS)
기간: Baseline (T1) and 2-months (T4)
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20 items (parent and teens); Likert scale (1= strongly disagree; 5= strongly agree)
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Baseline (T1) and 2-months (T4)
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Change in Confidence in exploring and using adolescent's strengths
기간: Baseline (T1) and 2-months (T4)
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15 items (parents and teens); Likert scale (1=strongly disagree; 5= strongly agree)
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Baseline (T1) and 2-months (T4)
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Feasibility of consent rates
기간: 9 months
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Feasibility will be demonstrated by consent rates ≥60%
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9 months
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Feasibility of intervention implementation
기간: 1 month
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Completion of core intervention components ≥ 70%.
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1 month
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Parent and adolescent acceptability of intervention materials
기간: 2-weeks post intervention (T3)
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Adolescent and parent acceptability ratings ≥80%.
Investigators will also elicit open-ended feedback.
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2-weeks post intervention (T3)
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Parent and adolescent acceptability of intervention materials (additional)
기간: 2-months post intervention (T4)
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2 items (parents and teens); Yes/No/Not sure and Likert scale (1=very likely; 5 very unlikely)
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2-months post intervention (T4)
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Provider acceptability of intervention
기간: 9 months
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Provider acceptability ratings ≥80%.
Investigators will also elicit open-ended feedback.
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9 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Psychological well-being using the Flourishing Scale
기간: Baseline (T1) and 2-months (T4)
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Measure of psychological well-being.
8 items (parents and teens).
(Likert scale 1= Strongly disagree; 2= Disagree; 3= Slightly disagree; 4= Mixed or neither agree nor disagree; 5= Slightly agree; 6= Agree; 7= Strongly agree).
Score will be summed for range of 8 (Strong Disagreement with all items) to 56 (Strong Agreement with items).
High scores signify that respondents view themselves in positive terms in important areas of functioning.
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Baseline (T1) and 2-months (T4)
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Change in Adherence to inhaled controller medication use
기간: Baseline (T1) and 2-months (T4)
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2-items about adherence to inhaled controller medication use (parent and teen) will be assessed using the Visual analog scale (0-10).
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Baseline (T1) and 2-months (T4)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Victoria A Miller, PhD, Children's Hospital of Phiadelphia
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Ford CA, Cheek C, Culhane J, Fishman J, Mathew L, Salek EC, Webb D, Jaccard J. Parent and Adolescent Interest in Receiving Adolescent Health Communication Information From Primary Care Clinicians. J Adolesc Health. 2016 Aug;59(2):154-61. doi: 10.1016/j.jadohealth.2016.03.001. Epub 2016 Apr 14.
- Ford CA, Davenport AF, Meier A, McRee AL. Partnerships between parents and health care professionals to improve adolescent health. J Adolesc Health. 2011 Jul;49(1):53-7. doi: 10.1016/j.jadohealth.2010.10.004. Epub 2011 Mar 12.
- Jaccard J, Dodge T, Dittus P. Parent-adolescent communication about sex and birth control: a conceptual framework. New Dir Child Adolesc Dev. 2002 Fall;(97):9-41. doi: 10.1002/cd.48. No abstract available.
- Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS. 2002 Jan 25;16(2):269-77. doi: 10.1097/00002030-200201250-00017.
- Viner RM, Christie D, Taylor V, Hey S. Motivational/solution-focused intervention improves HbA1c in adolescents with Type 1 diabetes: a pilot study. Diabet Med. 2003 Sep;20(9):739-42. doi: 10.1046/j.1464-5491.2003.00995.x.
- Elster AB, Kuznets NJ. AMA Guidelines for Adolescent Preventive Services (GAPS): Recommendations and Rationale. Baltimore: Williams & Wilkins; 1994.
- Hagan J, Shaw J, PM Duncan PM e. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents 4th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2017.
- Duncan PM, Garcia AC, Frankowski BL, Carey PA, Kallock EA, Dixon RD, Shaw JS. Inspiring healthy adolescent choices: a rationale for and guide to strength promotion in primary care. J Adolesc Health. 2007 Dec;41(6):525-35. doi: 10.1016/j.jadohealth.2007.05.024. Epub 2007 Aug 29.
- Catalano RF, Berglund ML, Ryan JAM, et al. Positive youth development in the United States: research findings on evaluations of positive youth development programs. Ann Am Acad Pol Soc Sci 2004;591:98 -125.
- Mangione-Smith R, DeCristofaro AH, Setodji CM, Keesey J, Klein DJ, Adams JL, Schuster MA, McGlynn EA. The quality of ambulatory care delivered to children in the United States. N Engl J Med. 2007 Oct 11;357(15):1515-23. doi: 10.1056/NEJMsa064637.
- Hammig B, Jozkowski K. Health Education Counseling During Pediatric Well-Child Visits in Physicians' Office Settings. Clin Pediatr (Phila). 2015 Jul;54(8):752-8. doi: 10.1177/0009922815584943. Epub 2015 Apr 29.
- Rosenberg AR, Yi-Frazier JP, Eaton L, Wharton C, Cochrane K, Pihoker C, Baker KS, McCauley E. Promoting Resilience in Stress Management: A Pilot Study of a Novel Resilience-Promoting Intervention for Adolescents and Young Adults With Serious Illness. J Pediatr Psychol. 2015 Oct;40(9):992-9. doi: 10.1093/jpepsy/jsv004. Epub 2015 Feb 11.
- Steinhardt MA, Mamerow MM, Brown SA, Jolly CA. A resilience intervention in African American adults with type 2 diabetes: a pilot study of efficacy. Diabetes Educ. 2009 Mar-Apr;35(2):274-84. doi: 10.1177/0145721708329698. Epub 2009 Feb 9.
- Maslow G, Adams C, Willis M, Neukirch J, Herts K, Froehlich W, Calleson D, Rickerby M. An evaluation of a positive youth development program for adolescents with chronic illness. J Adolesc Health. 2013 Feb;52(2):179-85. doi: 10.1016/j.jadohealth.2012.06.020. Epub 2012 Aug 17.
- Buchanan, C. M., & Holmbeck, G. N. (1998). Measuring beliefs about adolescent personality and behavior. J. Youth Adolescence 27(5): 607-627
- Olson, D. H. Family inventories: Inventories used in a national survey of families across the life cycle. St Paul, MN: Family Social Science, University of Minnesota. 1985
- Diener, E. et al. (2010). New Well-being Measures: Short Scales to Assess Flourishing and Positive and Negative Feelings. Social Indicators Research, 97(2), 143-156.
- Hair, EC et al. (2005). The Parent-Adolescent Relationship Scale. Adolescent & Family Health, 4(1), 12-25.
- Miller VA, Silva K, Friedrich E, Robles R, Ford CA. Efficacy of a Primary Care-Based Intervention to Promote Parent-Teen Communication and Well-Being: A Randomized Controlled Trial. J Pediatr. 2020 Jul;222:200-206.e2. doi: 10.1016/j.jpeds.2020.03.050. Epub 2020 May 19.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 5월 4일
기본 완료 (실제)
2019년 5월 31일
연구 완료 (실제)
2019년 5월 31일
연구 등록 날짜
최초 제출
2018년 3월 21일
QC 기준을 충족하는 최초 제출
2018년 4월 11일
처음 게시됨 (실제)
2018년 4월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 14일
마지막으로 확인됨
2019년 10월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 18-014922
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .