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Trial of the Teens and Toddlers Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01310543
First received: March 4, 2011
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pregnancy in Adolescence
 Behavioral: Teens and Toddlers
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: RCT of the Teens and Toddlers Intervention

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Use of contraception at last sex [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self-report measure based on pen and paper questionnaire


Secondary Outcome Measures:
  • Frequency of sex without contraception over the previous 3 months [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Also self-report (N.B. Because of the broad aims of the intervention this outcome is being treated as a primary outcome also)

  • Expectation of teenage parenthood [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Also self report (N.B. Because of the broad aims of the intervention this outcome is being treated as a primary outcome also)

  • Youth development [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Composite score derived from scaled items (N.B. Because of the broad aims of the intervention this outcome is being treated as a primary outcome also)

  • Teenage pregnancy [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self-report

  • Use of condoms at last sex [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self-report

  • Sex without condoms over the previous 3 months [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Examines episodes of sex without condom use via self report measure

  • emotional self-reflection [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self report

  • Emotional vocabulary [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self-report

  • Dislike of school [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self report

  • Knowledge of contraception [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Composite score drawing on several self-report items

  • Doesn't positively like self [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self-report

  • Believes best age to have sex <16 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self report

  • Attitude to unprotected sex [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self report

  • Believes it would be difficult to talk openly about sex with boyfriend [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self report

  • Believes it would be difficult to talk about the pill in clinic or with doctor [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Self report


Estimated Enrollment: 360
Study Start Date: December 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teens and Toddlers
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
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.
No Intervention: Comparison
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.

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  Eligibility

Ages Eligible for Study:   13 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Young women age 13/14
  2. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310543

Contacts
Contact: Ruth Smith, MSc 020 7549 9504 ruth.smith@natcen.ac.uk
Contact: Ivonne Wollney 020 7549 9504 ivonne.wollney@natcen.ac.uk

Locations
United Kingdom
National Centre for Social Research Recruiting
London, United Kingdom, EC1V 0AX
Sub-Investigator: Ruth Smith, MSc            
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Chris Bonell, PhD London School of Hygiene and Tropical Medicine
  More Information

No publications provided

Responsible Party: Chris Bonell/Senior Lecturer, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01310543     History of Changes
Other Study ID Numbers: TTRCT, TTRCT
Study First Received: March 4, 2011
Last Updated: April 11, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
Teenage pregnancy
Adolescent
Sexual health
Youth development

ClinicalTrials.gov processed this record on May 23, 2013