A Pilot Efficacy and Implementation Study of the Strengths Intervention Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Efficacy and Implementation Study of the Strengths Intervention Project

Conditions
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Parenting, Adolescent Behavior, Parent-Child Relations, Communication

Intervention / Treatment
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* Behavioral: Build and Support Your Teen's Strengths


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment groups receive intervention and control groups receive usual care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (Arm 1- Main)<br>Will receive the Build Your Teen's Strengths educational pamphlet, health coaching sessions, and provider endorsement. | Behavioral: Build and Support Your Teen's Strengths<br>* 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.<br>|
| No Intervention: Control Group (Arm 1- Main)<br>Will receive usual care at well-child visit. | |
| Experimental: Intervention Group (Arm 1-asthma subgroup)<br>Will receive the Build Your Teen's Strengths educational pamphlet, health coaching sessions, and provider endorsement. | Behavioral: Build and Support Your Teen's Strengths<br>* 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.<br>|
| No Intervention: Control Group (Arm 1-asthma subgroup)<br>Will receive usual care at well-child visit. | |
| No Intervention: Control Group (Arm 2)<br>Convenience sample used for a post-hoc, exploratory analysis. Will receive usual care at well-child visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beliefs about Adolescents | 26 items (parents only); Likert scale (1= very unlikely; 7= very, very likely) | Baseline (T1) and 2-months (T4) | 
| Change in Parent-Adolescent Communication (PACS) | 20 items (parent and teens); Likert scale (1= strongly disagree; 5= strongly agree) | Baseline (T1) and 2-months (T4) | 
| Change in Confidence in exploring and using adolescent's strengths | 15 items (parents and teens); Likert scale (1=strongly disagree; 5= strongly agree) | Baseline (T1) and 2-months (T4) | 
| Feasibility of consent rates | Feasibility will be demonstrated by consent rates ≥60% | 9 months | 
| Feasibility of intervention implementation | Completion of core intervention components ≥ 70%. | 1 month | 
| Parent and adolescent acceptability of intervention materials | Adolescent and parent acceptability ratings ≥80%. Investigators will also elicit open-ended feedback. | 2-weeks post intervention (T3) | 
| Parent and adolescent acceptability of intervention materials (additional) | 2 items (parents and teens); Yes/No/Not sure and Likert scale (1=very likely; 5 very unlikely) | 2-months post intervention (T4) | 
| Provider acceptability of intervention | Provider acceptability ratings ≥80%. Investigators will also elicit open-ended feedback. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Psychological well-being using the Flourishing Scale | 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. | Baseline (T1) and 2-months (T4) | 
| Change in Adherence to inhaled controller medication use | 2-items about adherence to inhaled controller medication use (parent and teen) will be assessed using the Visual analog scale (0-10). | Baseline (T1) and 2-months (T4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parent-teen communication, teen strengths, adolescence