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Completed

NCT Number: NCT03496155

A Pilot Efficacy and Implementation Study of the Strengths Intervention Project

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.

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Key information

Age range

13 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Build and Support Your Teen's Strengths

Behavioral

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • John Templeton Foundation

Registry information

Acronym: SIP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 12, 2018
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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