A Pilot Efficacy and Implementation Study of the Strengths Intervention Project

Not Applicable

Completed

• Conditions: Parent-Child Relations; Adolescent Behavior; Parenting; Communication
• Interventions: Behavioral: Build and Support Your Teen's Strengths

• Registration Number: NCT03496155
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-12
• Study Start: 2018-05-04
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group (Arm 1- Main)	Build and Support Your Teen's Strengths	Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
Intervention Group (Arm 1-asthma subgroup)	Build and Support Your Teen's Strengths	Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Psychological well-being using the Flourishing Scale	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.
Change in Adherence to inhaled controller medication use	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).

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States