Clinical trial NCT03496155: A Pilot Efficacy and Implementation Study of the Strengths Intervention Project
Official title: A Pilot Efficacy and Implementation Study of the Strengths Intervention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Parenting
Adolescent Behavior
Communication
Keywords: parent-teen communication
teen strengths
adolescence
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: John Templeton Foundation
First posted: 2018-04-12
Enrollment: 174
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment groups receive intervention and control groups receive usual care.
Primary purpose: OTHER

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.

Eligibility 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)

Primary outcomes:
measure: Change in Beliefs about Adolescents
timeFrame: Baseline (T1) and 2-months (T4)
measure: Change in Parent-Adolescent Communication (PACS)
timeFrame: Baseline (T1) and 2-months (T4)
measure: Change in Confidence in exploring and using adolescent's strengths
timeFrame: Baseline (T1) and 2-months (T4)
measure: Feasibility of consent rates
timeFrame: 9 months
measure: Feasibility of intervention implementation
timeFrame: 1 month
measure: Parent and adolescent acceptability of intervention materials
timeFrame: 2-weeks post intervention (T3)
measure: Parent and adolescent acceptability of intervention materials (additional)
timeFrame: 2-months post intervention (T4)
measure: Provider acceptability of intervention
timeFrame: 9 months
Secondary outcomes:
measure: Change in Psychological well-being using the Flourishing Scale
timeFrame: Baseline (T1) and 2-months (T4)
measure: Change in Adherence to inhaled controller medication use
timeFrame: Baseline (T1) and 2-months (T4)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Phiadelphia
name: Victoria A Miller, PhD
role: PRINCIPAL_INVESTIGATOR
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