A Pilot Efficacy and Implementation Study of the Strengths Intervention Project

NCT03496155 | Completed

• 1 other identifier: 18-014922
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Parent-Child Relations; Parenting; Adolescent Behavior; Communication

Keywords

parent-teen communication; teen strengths; adolescence

Outcome Measures

Primary Outcomes (8)

• Change in Beliefs about Adolescents

  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)

  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

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

  Baseline (T1) and 2-months (T4)

• Feasibility of consent rates

  Feasibility will be demonstrated by consent rates ≥60%

  9 months

• Feasibility of intervention implementation

  Completion of core intervention components ≥ 70%.

  1 month

• Parent and adolescent acceptability of intervention materials

  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)

  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

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

  9 months

Secondary Outcomes (2)

• Change in Psychological well-being using the Flourishing Scale

  Baseline (T1) and 2-months (T4)

• Change in Adherence to inhaled controller medication use

  Baseline (T1) and 2-months (T4)

Study Arms (5)

Intervention Group (Arm 1- Main)

EXPERIMENTAL

Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.

Behavioral: Build and Support Your Teen's Strengths

Control Group (Arm 1- Main)

NO INTERVENTION

Will receive usual care at well-child visit.

Intervention Group (Arm 1-asthma subgroup)

EXPERIMENTAL

Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.

Behavioral: Build and Support Your Teen's Strengths

Control Group (Arm 1-asthma subgroup)

NO INTERVENTION

Will receive usual care at well-child visit.

Control Group (Arm 2)

NO INTERVENTION

Convenience sample used for a post-hoc, exploratory analysis. Will receive usual care at well-child visit.

Interventions

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.

Intervention Group (Arm 1- Main); Intervention Group (Arm 1-asthma subgroup)

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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:
• 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)
• 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)

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• John Templeton Foundation: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (20)

• 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.

  PMID: 27151760 BACKGROUND

• 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.

  PMID: 14964942 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21700157 BACKGROUND

• 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.

  PMID: 18023780 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17928599 BACKGROUND

• 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.

  PMID: 25926665 BACKGROUND

• 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.

  PMID: 12925054 BACKGROUND

• 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.

  PMID: 25678533 BACKGROUND

• 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.

  PMID: 19204102 BACKGROUND

• 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.

  PMID: 23332482 BACKGROUND

• 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.

  PMID: 7390914 BACKGROUND

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

  BACKGROUND

• Olson, D. H. Family inventories: Inventories used in a national survey of families across the life cycle. St Paul, MN: Family Social Science, University of Minnesota. 1985

  BACKGROUND

• Diener, E. et al. (2010). New Well-being Measures: Short Scales to Assess Flourishing and Positive and Negative Feelings. Social Indicators Research, 97(2), 143-156.

  BACKGROUND

• Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS. 2002 Jan 25;16(2):269-77. doi: 10.1097/00002030-200201250-00017.

  PMID: 11807312 BACKGROUND

• Hair, EC et al. (2005). The Parent-Adolescent Relationship Scale. Adolescent & Family Health, 4(1), 12-25.

  BACKGROUND

• Miller VA, Silva K, Friedrich E, Robles R, Ford CA. Efficacy of a Primary Care-Based Intervention to Promote Parent-Teen Communication and Well-Being: A Randomized Controlled Trial. J Pediatr. 2020 Jul;222:200-206.e2. doi: 10.1016/j.jpeds.2020.03.050. Epub 2020 May 19.

  PMID: 32444221 DERIVED

MeSH Terms

Conditions

Adolescent Behavior; Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Victoria A Miller, PhD

  Children's Hospital of Phiadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment groups receive intervention and control groups receive usual care.

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 12, 2018
• Study Start: May 4, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)