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

14. oktober 2019 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

174

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • The Children's Hospital of Philadelphia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år til 15 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Beliefs about Adolescents
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 9 months
Feasibility will be demonstrated by consent rates ≥60%
9 months
Feasibility of intervention implementation
Tidsramme: 1 month
Completion of core intervention components ≥ 70%.
1 month
Parent and adolescent acceptability of intervention materials
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 9 months
Provider acceptability ratings ≥80%. Investigators will also elicit open-ended feedback.
9 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Psychological well-being using the Flourishing Scale
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Children's Hospital of Philadelphia

Samarbeidspartnere

John Templeton Foundation

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. mai 2018

Primær fullføring (Faktiske)

31. mai 2019

Studiet fullført (Faktiske)

31. mai 2019

Datoer for studieregistrering

Først innsendt

21. mars 2018

Først innsendt som oppfylte QC-kriteriene

11. april 2018

Først lagt ut (Faktiske)

12. april 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 18-014922

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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