AzTrials
AzTrials

Parent-Child RelationsSIPNCT03496155

A Pilot Efficacy and Implementation Study of the Strengths Intervention Project

A study testing Build and Support Your Teen's Strengths in people with Parent-Child Relations and Parenting, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 13 to 15 years
What is being tested?
Build and Support Your Teen's Strengths
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteUnited States
Study dates
4 May 2018to 31 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)
  • 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)

Who cannot join

  • 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)
Show all 9Show fewer
  • Parent 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the 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.

Being tested
Build and Support Your Teen's Strengths
Keywords
parent-teen communication, teen strengths, adolescence
Medical subject headings
Adolescent Behavior, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Build and Support Your Teen's StrengthsBehavioural

    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.

Study groups in NCT03496155
Study groupRoleWhat they receive
Intervention Group (Arm 1- Main)ExperimentalWill receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
Receives: Behavioral: Build and Support Your Teen's Strengths
Control Group (Arm 1- Main)No interventionWill receive usual care at well-child visit.
Intervention Group (Arm 1-asthma subgroup)ExperimentalWill receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
Receives: Behavioral: Build and Support Your Teen's Strengths
Control Group (Arm 1-asthma subgroup)No interventionWill receive usual care at well-child visit.
Control Group (Arm 2)No interventionConvenience sample used for a post-hoc, exploratory analysis. Will receive usual care at well-child visit.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Beliefs about Adolescents

    26 items (parents only); Likert scale (1= very unlikely; 7= very, very likely)

    Measured: Baseline (T1) and 2-months (T4)

  2. Change in Parent-Adolescent Communication (PACS)

    20 items (parent and teens); Likert scale (1= strongly disagree; 5= strongly agree)

    Measured: Baseline (T1) and 2-months (T4)

  3. Change in Confidence in exploring and using adolescent's strengths

    15 items (parents and teens); Likert scale (1=strongly disagree; 5= strongly agree)

    Measured: Baseline (T1) and 2-months (T4)

  4. Feasibility of consent rates

    Feasibility will be demonstrated by consent rates ≥60%

    Measured: 9 months

  5. Feasibility of intervention implementation

    Completion of core intervention components ≥ 70%.

    Measured: 1 month

  6. Parent and adolescent acceptability of intervention materials

    Adolescent and parent acceptability ratings ≥80%. Investigators will also elicit open-ended feedback.

    Measured: 2-weeks post intervention (T3)

  7. Parent and adolescent acceptability of intervention materials (additional)

    2 items (parents and teens); Yes/No/Not sure and Likert scale (1=very likely; 5 very unlikely)

    Measured: 2-months post intervention (T4)

  8. Provider acceptability of intervention

    Provider acceptability ratings ≥80%. Investigators will also elicit open-ended feedback.

    Measured: 9 months

Secondary outcomes (2)
  1. Change in Psychological well-being using the Flourishing Scale

    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.

    Measured: Baseline (T1) and 2-months (T4)

  2. Change in Adherence to inhaled controller medication use

    2-items about adherence to inhaled controller medication use (parent and teen) will be assessed using the Visual analog scale (0-10).

    Measured: Baseline (T1) and 2-months (T4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study start4 May 2018
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Treatment groups receive intervention and control groups receive usual care.
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03496155
Sponsor's protocol ID
18-014922
Acronym
SIP
Status last verified
Oct 2019
First submitted
21 Mar 2018
Last updated
15 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ford CA, Cheek C, Culhane J, Fishman J, Mathew L, Salek EC, Webb D, Jaccard J. Parent and Adolescent Interest in Receiving Adolescent Health Communication Information From Primary Care Clinicians. J Adolesc Health. 2016 Aug;59(2):154-61. doi: 10.1016/j.jadohealth.2016.03.001. Epub 2016 Apr 14.

    PubMed 27151760
  • Jaccard J, Dodge T, Dittus P. Parent-adolescent communication about sex and birth control: a conceptual framework. New Dir Child Adolesc Dev. 2002 Fall;(97):9-41. doi: 10.1002/cd.48. No abstract available.

    PubMed 14964942
  • Elster AB, Kuznets NJ. AMA Guidelines for Adolescent Preventive Services (GAPS): Recommendations and Rationale. Baltimore: Williams & Wilkins; 1994.

  • Hagan J, Shaw J, PM Duncan PM e. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents 4th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2017.

  • Ford CA, Davenport AF, Meier A, McRee AL. Partnerships between parents and health care professionals to improve adolescent health. J Adolesc Health. 2011 Jul;49(1):53-7. doi: 10.1016/j.jadohealth.2010.10.004. Epub 2011 Mar 12.

    PubMed 21700157
  • Duncan PM, Garcia AC, Frankowski BL, Carey PA, Kallock EA, Dixon RD, Shaw JS. Inspiring healthy adolescent choices: a rationale for and guide to strength promotion in primary care. J Adolesc Health. 2007 Dec;41(6):525-35. doi: 10.1016/j.jadohealth.2007.05.024. Epub 2007 Aug 29.

    PubMed 18023780
  • Catalano RF, Berglund ML, Ryan JAM, et al. Positive youth development in the United States: research findings on evaluations of positive youth development programs. Ann Am Acad Pol Soc Sci 2004;591:98 -125.

  • Mangione-Smith R, DeCristofaro AH, Setodji CM, Keesey J, Klein DJ, Adams JL, Schuster MA, McGlynn EA. The quality of ambulatory care delivered to children in the United States. N Engl J Med. 2007 Oct 11;357(15):1515-23. doi: 10.1056/NEJMsa064637.

    PubMed 17928599
  • Hammig B, Jozkowski K. Health Education Counseling During Pediatric Well-Child Visits in Physicians' Office Settings. Clin Pediatr (Phila). 2015 Jul;54(8):752-8. doi: 10.1177/0009922815584943. Epub 2015 Apr 29.

    PubMed 25926665
  • Viner RM, Christie D, Taylor V, Hey S. Motivational/solution-focused intervention improves HbA1c in adolescents with Type 1 diabetes: a pilot study. Diabet Med. 2003 Sep;20(9):739-42. doi: 10.1046/j.1464-5491.2003.00995.x.

    PubMed 12925054
  • Rosenberg AR, Yi-Frazier JP, Eaton L, Wharton C, Cochrane K, Pihoker C, Baker KS, McCauley E. Promoting Resilience in Stress Management: A Pilot Study of a Novel Resilience-Promoting Intervention for Adolescents and Young Adults With Serious Illness. J Pediatr Psychol. 2015 Oct;40(9):992-9. doi: 10.1093/jpepsy/jsv004. Epub 2015 Feb 11.

    PubMed 25678533
  • Steinhardt MA, Mamerow MM, Brown SA, Jolly CA. A resilience intervention in African American adults with type 2 diabetes: a pilot study of efficacy. Diabetes Educ. 2009 Mar-Apr;35(2):274-84. doi: 10.1177/0145721708329698. Epub 2009 Feb 9.

    PubMed 19204102
  • Maslow G, Adams C, Willis M, Neukirch J, Herts K, Froehlich W, Calleson D, Rickerby M. An evaluation of a positive youth development program for adolescents with chronic illness. J Adolesc Health. 2013 Feb;52(2):179-85. doi: 10.1016/j.jadohealth.2012.06.020. Epub 2012 Aug 17.

    PubMed 23332482
  • Schoenfeld D. Statistical considerations for pilot studies. Int J Radiat Oncol Biol Phys. 1980 Mar;6(3):371-4. doi: 10.1016/0360-3016(80)90153-4. No abstract available.

    PubMed 7390914
  • Buchanan, C. M., & Holmbeck, G. N. (1998). Measuring beliefs about adolescent personality and behavior. J. Youth Adolescence 27(5): 607-627

Questions about this trial

What is this clinical trial studying?

A study testing Build and Support Your Teen's Strengths in people with Parent-Child Relations and Parenting, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Beliefs about Adolescents (time frame: Baseline (T1) and 2-months (T4)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03496155, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in