Trial of the Teens and Toddlers Intervention

NCT01310543 | Completed Phase 3 DMC

• 1 other identifier: TTRCT
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 1

Brief Summary

Teens and Toddlers is an intervention that enables young people at risk of teenage pregnancy to spend time mentoring a toddler as well as participating in counselling and classroom work focused on youth development. This trial aims to test primary hypotheses that girls age 13/14 who are randomly allocated to participate in the T\&T intervention are more likely to report use of contraception at last sex, less likely to report frequent sex without contraception over the previous 3 months, less likely to expect to become teenage parents and more likely to report high scores for youth development indicators one year after the intervention than are similar girls who are randomised not to participate. The trial involves a total of 180 girls per arm and is being conducted across England funded by the Department for Education and conducted by the London School of Hygiene and the National Centre for Social Research.

Conditions

Pregnancy in Adolescence

Keywords

Teenage pregnancy; Adolescent; Sexual health; Youth development

Outcome Measures

Primary Outcomes (1)

• Use of contraception at last sex

  Self-report measure based on pen and paper questionnaire

  72 weeks

Secondary Outcomes (15)

• Frequency of sex without contraception over the previous 3 months

  72 weeks

• Expectation of teenage parenthood

  72 weeks

• Youth development

  72 weeks

• Teenage pregnancy

  72 weeks

• Use of condoms at last sex

  72 weeks

Study Arms (2)

Teens and Toddlers

EXPERIMENTAL

The T\&T intervention aims to prevent teenage pregnancy and promote sexual health by providing young women at risk of teenage pregnancy with regular and direct contact with a toddler and combines this with 12 modules of group-based personal-development sessions involving communication skills, anger management, discussion of positive sexual health and relationships, culminating in an accredited National Award in Interpersonal Skills. One-to-one life coaching is also provided. The intervention consists of 20 weekly afternoon sessions run in nurseries near to the secondary schools from which participating young women are recruited.

Behavioral: Teens and Toddlers

Comparison

NO INTERVENTION

Girls in the comparison group will continue with their normal afternoon of schooling, which is missed by girls attending the T\&T intervention for the 20 weeks of their attendance.

Interventions

Teens and Toddlers BEHAVIORAL

The T\&T intervention aims to prevent teenage pregnancy and promote sexual health by providing young women at risk of teenage pregnancy with regular and direct contact with a toddler and combines this with 12 modules of group-based personal-development sessions involving communication skills, anger management, discussion of positive sexual health and relationships, culminating in an accredited National Award in Interpersonal Skills. One-to-one life coaching is also provided. The intervention consists of 20 weekly afternoon sessions run in nurseries near to the secondary schools from which participating young women are recruited.

Teens and Toddlers

Eligibility Criteria

• Age: 13 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Young women age 13/14
• Perceived by teachers as:disengaged from or uninterested in school; not working to their potential in school; exhibiting poor or disruptive behaviour in class; having a poor attendance record; parents rarely/never attending parents' evenings; parent or sibling being a teenage parent; and/or being currently/previously in care

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

National Centre for Social Research

London, London, EC1V 0AX, United Kingdom

Location

Study Officials

• Chris Bonell, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 8, 2011
• Study Start: December 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 14, 2016

Record last verified: 2011-04

Locations

GB (1)