A Pilot Efficacy and Implementation Study of the Strengths Intervention Project
NCT ID: NCT03496155
Last Updated: 2019-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
174 participants
INTERVENTIONAL
2018-05-04
2019-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of School-Based Cognitive Behavioral Therapy in Preventing Depression in Young Adolescents
NCT00360451
Strong Connections
NCT03308864
Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings
NCT01201382
Pilot Study of an Internet-based Parenting Program for Child Disruptive Behavior
NCT06386562
Targeting Adolescent Depressive Symptoms Via Brief, Web-Based Interventions
NCT04066985
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group (Arm 1- Main)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
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.
Control Group (Arm 1- Main)
Will receive usual care at well-child visit.
No interventions assigned to this group
Intervention Group (Arm 1-asthma subgroup)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
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.
Control Group (Arm 1-asthma subgroup)
Will receive usual care at well-child visit.
No interventions assigned to this group
Control Group (Arm 2)
Convenience sample used for a post-hoc, exploratory analysis. Will receive usual care at well-child visit.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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)
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
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:
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)
13 Years
15 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
John Templeton Foundation
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Victoria A Miller, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Phiadelphia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Buchanan, C. M., & Holmbeck, G. N. (1998). Measuring beliefs about adolescent personality and behavior. J. Youth Adolescence 27(5): 607-627
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
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.
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.
Hair, EC et al. (2005). The Parent-Adolescent Relationship Scale. Adolescent & Family Health, 4(1), 12-25.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-014922
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.