A Pilot Efficacy and Implementation Study of the Strengths Intervention Project

Parenting Clinical Trial

— SIP  

Official title:

A Pilot Efficacy and Implementation Study of the Strengths Intervention Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496155
• Other study ID #: 18-014922
• Status: Completed
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: October 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adolescent Behavior
• Communication
• Parent-Child Relations
• Parenting

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	John Templeton Foundation

Country where clinical trial is conducted

United States, 

References & Publications (19)

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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.

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.

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. Epub 2007 Aug 29. Review. — View Citation

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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. — View Citation

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. — View Citation

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.

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

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. — View Citation

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. Review. — View Citation

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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. — View Citation

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

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. — View Citation

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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. — View Citation

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. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Beliefs about Adolescents	26 items (parents only); Likert scale (1= very unlikely; 7= very, very likely)	Baseline (T1) and 2-months (T4)
Primary	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)
Primary	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)
Primary	Feasibility of consent rates	Feasibility will be demonstrated by consent rates =60%	9 months
Primary	Feasibility of intervention implementation	Completion of core intervention components = 70%.	1 month
Primary	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)
Primary	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)
Primary	Provider acceptability of intervention	Provider acceptability ratings =80%. Investigators will also elicit open-ended feedback.	9 months
Secondary	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.	Baseline (T1) and 2-months (T4)
Secondary	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).	Baseline (T1) and 2-months (T4)

External Links

•   Force UPST. USPSTF A and B Recommendations. 2017
•   Institute P-COR. PCORI's Stakeholders. 2016