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Trial record 64 of 10357 for:    strength

A Pilot Efficacy and Implementation Study of the Strengths Intervention Project (SIP)

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ClinicalTrials.gov Identifier: NCT03496155
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
John Templeton Foundation
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parent-Child Relations Parenting Adolescent Behavior Communication Behavioral: Build and Support Your Teen's Strengths Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Treatment groups receive intervention and control groups receive usual care.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Efficacy and Implementation Study of the Strengths Intervention Project
Actual Study Start Date : May 4, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Arm Intervention/treatment
Experimental: Intervention Group (Arm 1- Main)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
Behavioral: Build and Support Your Teen's Strengths
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.

No Intervention: Control Group (Arm 1- Main)
Will receive usual care at well-child visit.
Experimental: Intervention Group (Arm 1-asthma subgroup)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
Behavioral: Build and Support Your Teen's Strengths
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.

No Intervention: Control Group (Arm 1-asthma subgroup)
Will receive usual care at well-child visit.
No Intervention: Control Group (Arm 2)
Convenience sample used for a post-hoc, exploratory analysis. Will receive usual care at well-child visit.



Primary Outcome Measures :
  1. Change in Beliefs about Adolescents [ Time Frame: Baseline (T1) and 2-months (T4) ]
    26 items (parents only); Likert scale (1= very unlikely; 7= very, very likely)

  2. Change in Parent-Adolescent Communication (PACS) [ Time Frame: Baseline (T1) and 2-months (T4) ]
    20 items (parent and teens); Likert scale (1= strongly disagree; 5= strongly agree)

  3. Change in Confidence in exploring and using adolescent's strengths [ Time Frame: Baseline (T1) and 2-months (T4) ]
    15 items (parents and teens); Likert scale (1=strongly disagree; 5= strongly agree)

  4. Feasibility of consent rates [ Time Frame: 9 months ]
    Feasibility will be demonstrated by consent rates ≥60%

  5. Feasibility of intervention implementation [ Time Frame: 1 month ]
    Completion of core intervention components ≥ 70%.

  6. Parent and adolescent acceptability of intervention materials [ Time Frame: 2-weeks post intervention (T3) ]
    Adolescent and parent acceptability ratings ≥80%. Investigators will also elicit open-ended feedback.

  7. Parent and adolescent acceptability of intervention materials (additional) [ Time Frame: 2-months post intervention (T4) ]
    2 items (parents and teens); Yes/No/Not sure and Likert scale (1=very likely; 5 very unlikely)

  8. Provider acceptability of intervention [ Time Frame: 9 months ]
    Provider acceptability ratings ≥80%. Investigators will also elicit open-ended feedback.


Secondary Outcome Measures :
  1. Change in Psychological well-being using the Flourishing Scale [ Time Frame: Baseline (T1) and 2-months (T4) ]
    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.

  2. Change in Adherence to inhaled controller medication use [ Time Frame: Baseline (T1) and 2-months (T4) ]
    2-items about adherence to inhaled controller medication use (parent and teen) will be assessed using the Visual analog scale (0-10).



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Adolescent Criteria:

Inclusion Criteria:

  1. 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)
  2. Children's Hospital of Philadelphia (CHOP) primary care patient (Arm 1 and 2)
  3. 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)
  4. Diagnosed with Asthma > year (asthma subgroup; Arm 1 only)
  5. Prescribed a controller medication year-round (asthma subgroup; Arm 1 only)
  6. Adolescent has their own email account to complete electronic surveys (Arm 1 and 2)

Exclusion Criteria:

  1. Not fluent in written or spoken English (Arm 1 and 2)
  2. Attending a new patient well-child visit (Arm 1) OR attended a new patient well-child visit (Arm 2)
  3. Presence of developmental delay or pervasive developmental disorder that requires special education services (Arm 1 and 2)
  4. Psychiatric hospitalization of the adolescent in the past year (Arm 1 and 2)
  5. Participated in studies: CHOP IRB # 15-011732 and/or CHOP IRB # 17-013895 (Arm 1 and 2)
  6. Adolescent has sibling enrolled in (IRB 18-014922) (Arm 1 and 2)

Parent Criteria:

Inclusion Criteria:

  1. 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)
  2. Parent has their own email account to complete electronic surveys (Arm 1 and 2)

Exclusion Criteria:

  1. Not fluent in written or spoken English (Arm 1 and 2)
  2. Participated in studies: CHOP IRB # 15-011732 and/or CHOP IRB # 17-013895 (Arm 1 and 2)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496155


Locations
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United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
John Templeton Foundation
Investigators
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Principal Investigator: Victoria A Miller, PhD Children's Hospital of Phiadelphia

Additional Information:
Publications:
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.
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.
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.

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03496155     History of Changes
Other Study ID Numbers: 18-014922
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
parent-teen communication
teen strengths
adolescence