Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

14 oktober 2019 uppdaterad av: Children's Hospital of Philadelphia
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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

174

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • The Children's Hospital of Philadelphia

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

13 år till 15 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention Group (Arm 1- Main)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
Beteende: 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.
Inget ingripande: Control Group (Arm 1- Main)
Will receive usual care at well-child visit.
Experimentell: Intervention Group (Arm 1-asthma subgroup)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
Beteende: 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.
Inget ingripande: Control Group (Arm 1-asthma subgroup)
Will receive usual care at well-child visit.
Inget ingripande: Control Group (Arm 2)
Convenience sample used for a post-hoc, exploratory analysis. Will receive usual care at well-child visit.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Beliefs about Adolescents
Tidsram: Baseline (T1) and 2-months (T4)
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)
Tidsram: Baseline (T1) and 2-months (T4)
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
Tidsram: Baseline (T1) and 2-months (T4)
15 items (parents and teens); Likert scale (1=strongly disagree; 5= strongly agree)
Baseline (T1) and 2-months (T4)
Feasibility of consent rates
Tidsram: 9 months
Feasibility will be demonstrated by consent rates ≥60%
9 months
Feasibility of intervention implementation
Tidsram: 1 month
Completion of core intervention components ≥ 70%.
1 month
Parent and adolescent acceptability of intervention materials
Tidsram: 2-weeks post intervention (T3)
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)
Tidsram: 2-months post intervention (T4)
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
Tidsram: 9 months
Provider acceptability ratings ≥80%. Investigators will also elicit open-ended feedback.
9 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Psychological well-being using the Flourishing Scale
Tidsram: 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.
Baseline (T1) and 2-months (T4)
Change in Adherence to inhaled controller medication use
Tidsram: 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).
Baseline (T1) and 2-months (T4)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Children's Hospital of Philadelphia

Samarbetspartners

John Templeton Foundation

Utredare

  • Huvudutredare: Victoria A Miller, PhD, Children's Hospital of Phiadelphia

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 maj 2018

Primärt slutförande (Faktisk)

31 maj 2019

Avslutad studie (Faktisk)

31 maj 2019

Studieregistreringsdatum

Först inskickad

21 mars 2018

Först inskickad som uppfyllde QC-kriterierna

11 april 2018

Första postat (Faktisk)

12 april 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 oktober 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 oktober 2019

Senast verifierad

1 oktober 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 18-014922

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Kommunikation

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Jordan

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

Prenumerera