Motivational Interviewing for Getting Healthy TodaY Study

Pregnancy Related Clinical Trial

— MIGHTY  

Official title:

Computer-Assisted Motivational Interviewing Intervention to Facilitate Teen Pregnancy Prevention and Fitness Behavior Changes: A Randomized Trial for Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410225
• Other study ID #: AAAR5303
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: August 28, 2019

Study information

• Verified date: October 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study aims to test and rigorously evaluate the effectiveness of a computer-assisted motivational interviewing (CAMI) intervention that has already been shown to be successful with young women by reducing the risk of rapid subsequent birth among adolescent mothers, and applying this intervention to young men.

The purpose of the intervention is to increase condom use, increase female partner use of moderately or highly effective contraception, and increase completion of a reproductive health visit and STI/HIV testing.

The primary hypothesis is that the CAMI-TPP (CAMI aimed at Teen Pregnancy Prevention) intervention will increase the proportion of participants who do not engage in risky sex, report condom use at last intercourse as well as partner use of contraception compared to those in the Fitness group. It is also predicted that young men who receive the CAMI-TPP will report higher completion of a reproductive health service visit with sexually transmitted infection (STI) testing over the course of study participation compared to those in the CAMI-Fitness (CAMI aimed at healthy diet, physical activity and tobacco avoidance) group.

Description:

Most teen pregnancies (82%) in the United States are unintended. Actively engaging young men in preventing teen pregnancy is a necessary and central component to effecting change. Young men, aged 15-19 and 20-24 years, father most of the children born to teen mothers. Few interventions have been designed specifically or shown to be effective for young men in reducing teen pregnancy.

Counseling and feedback based on Motivational Interviewing (MI) principles demonstrated greater success than standard, didactic advice in several domains of behavior change. The effectiveness of this type of counseling to alter young men's sexual and contraceptive behaviors has not been rigorously evaluated.

Participants will be randomly chosen (like flipping a coin) to take part in one of the two MI projects, and you will get coaching and use an app for that project to improve your health. One project is on teen pregnancy prevention and the other is on healthy eating, physical activity, and avoiding cigarettes. Participants will use an app via phone to do the project, answer survey questions, keep track of health, and learn more about healthy behaviors.

Three hundred young men, ages 15 to 24 years, will be randomized to one of two intervention arms, a modified CAMI aimed at Teen Pregnancy Prevention (CAMI-TPP) or a CAMI aimed at healthy diet, physical activity and tobacco avoidance (CAMI-Fitness). The two interventions are identical in length and timing but vary in the target behavior focus (pregnancy prevention versus fitness).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 28, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 24 Years

Eligibility

Inclusion Criteria:

• Young men aged 15-24

• Sexually active with female partners

• Enrolled patients at New York Presbyterian Hospital's Young Men's Clinic (YMC) in Washington Heights or the school-based health centers (SBHCs) at George Washington Educational Campus in Washington Heights or John F. Kennedy campus in the Bronx

Exclusion Criteria:

• Do not have iPhone or Android Smartphone

• Participated in any of the following programs within the last year, or have a brother who has participated in these programs:

• Fathers Raising Responsible Men (FRRM)

• Peer Group Connection (PGC)

• NYC Teens Connection

• Children's AID Society (CAS)-TPP Initiative

• Achieving Condom Empowerment-Plus (ACE+) Study

• Have had a medical treatment or surgical procedure that makes it impossible to father a child, such as a vasectomy

• Cannot commit to participating in a smartphone-based study for the next 15 months

Related Conditions & MeSH terms

• Diet Modification
• Pregnancy Related

Intervention

Behavioral:
• CAMI-TPP
The TPP group will receive four 30-minute sessions of one-on-one coaching over 12 weeks with a MI coach; the sessions will be guided by personalized feedback aimed at increasing condom use, supporting female partners in contraceptive use, and obtaining reproductive health services and STI testing. MI counseling sessions will be conducted by phone or video call.
• CAMI-Fitness
The Fitness group will also receive four 30-minute sessions of one-on-one coaching over 12 weeks with a MI coach; these sessions will be guided by personalized feedback aimed at healthy diet, physical activity and tobacco avoidance. MI counseling sessions will be conducted by phone or video call.

Locations

Country	Name	City	State
United States	George Washington Educational Campus School-Based Health Center	New York	New York
United States	John F. Kennedy Educational Campus School-Based Health Center	New York	New York
United States	The Young Men's Clinic	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Centers for Disease Control and Prevention, The Office of Adolescent Health, HHS

Country where clinical trial is conducted

United States, 

References & Publications (8)

Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. Epub 2007 Mar 10. — View Citation

Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United States, 2001-2008. Am J Public Health. 2014 Feb;104 Suppl 1:S43-8. doi: 10.2105/AJPH.2013.301416. Epub 2013 Dec 19. — View Citation

Hollis JF, Polen MR, Whitlock EP, Lichtenstein E, Mullooly JP, Velicer WF, Redding CA. Teen reach: outcomes from a randomized, controlled trial of a tobacco reduction program for teens seen in primary medical care. Pediatrics. 2005 Apr;115(4):981-9. — View Citation

Jensen CD, Cushing CC, Aylward BS, Craig JT, Sorell DM, Steele RG. Effectiveness of motivational interviewing interventions for adolescent substance use behavior change: a meta-analytic review. J Consult Clin Psychol. 2011 Aug;79(4):433-40. doi: 10.1037/a0023992. Review. — View Citation

Males MA. Adult involvement in teenage childbearing and STD. Lancet. 1995 Jul 8;346(8967):64-5. — View Citation

Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep. 2012 Aug 28;61(1):1-72. — View Citation

McCambridge J, Strang J. The efficacy of single-session motivational interviewing in reducing drug consumption and perceptions of drug-related risk and harm among young people: results from a multi-site cluster randomized trial. Addiction. 2004 Jan;99(1):39-52. — View Citation

Weinstein P, Harrison R, Benton T. Motivating mothers to prevent caries: confirming the beneficial effect of counseling. J Am Dent Assoc. 2006 Jun;137(6):789-93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of participants that had sexual intercourse without using a condom since the last assessment Condom use at last sex	In the past 3 months, how many times have you had sexual intercourse without using a condom?	Baseline and 12 weeks
Secondary	Change in number of participants that had sexual intercourse in the past without the partner using any contraception since the last assessment	In the past 3 months, how many times have you had sexual intercourse without using any of these methods of birth control?	Baseline and 12 weeks
Secondary	Number of participants completing a reproductive health service visit with STI testing	In the last 3 months, that is, since {current date minus 3 months} , have you been tested by a doctor, nurse, or health provider for a sexually transmitted disease like gonorrhea, chlamydia, herpes, or syphilis (not including HIV)?	Baseline and 12 weeks