CBT for Young Mothers (CBTYM)

April 13, 2021 updated by: Ryan Van Lieshout, MD, PhD, McMaster University

Building Resilience in Young Mothers: A CBT-Based Curriculum

Approximately 1 in 4 adolescent mothers will develop depression after delivering a child, though some studies suggest that as many as 53% will develop postpartum depression. A frequent accompanying symptom is emotion dysregulation which not only adversely affects their mental well-being, but jeopardizes their parenting and their child's health. Unfortunately significant barriers exist for young mothers, preventing access to treatment. This study will pilot the feasibility of having public health nurses deliver this 9-session program within a curriculum for teen mothers.

Study Overview

Status

Completed

Detailed Description

Up to 50% of women who become parents during the teenage years suffer from mental disorders after the birth of their children. While they most commonly develop depression, anxiety problems and substance use disorders are also common, and in many cases they are comorbid. A significant proportion of these young women will also manifest impairing but sub-syndromal levels of symptoms. A frequent accompanying symptom is emotion dysregulation which not only adversely affects their mental well-being, but jeopardizes their parenting and their child's health, as well as longer-term labour market outcomes.

Perinatal mental disorders are associated with significant suffering and high health care costs. Indeed, a single case of postpartum depression is estimated to cost $150,000, a figure that may be even higher in young mothers. Compounding these adverse effects is the fact that just 15% of women with young children and mental disorders receive evidence-based care, numbers that are almost certainly lower in young mothers given their well-known difficulties engaging in health care.

Getting these young women to engage in treatment can be a significant challenge, but given the substantial risks and costs associated with mental disorders in this group, as well as the effectiveness of preventive and treatment interventions (particularly the psychotherapies), it is important that innovative ways to engage and support adolescent mothers be developed. Since many will attend school either in a traditional or adapted setting, the educational system provides an ideal place to deliver interventions aimed at optimizing the mental health of teenage mothers.

The purpose of this pilot study is to develop and establish the feasibility of having public health nurses deliver a 9-session group cognitive behavioural therapy-based resilience curriculum within a school program for teenage mothers at the District School Board of Niagara. In addition to establishing the feasibility and acceptability of the curriculum, estimates of intervention effect and its variance will be generated to support a later large-scale study aimed at assessing its effectiveness.

CBT-based curriculum has been developed to help build resilience and optimize mood, anxiety, and emotion regulation in 15-24 year old women attending a supported school program in Niagara Region. Sixty women will be recruited and changes in depression, anxiety, emotion regulation, parenting, and behavioural problems in their children will be measured pre-group, immediately post-group, and 6 months later.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Welland, Ontario, Canada, L3B3W9
        • Strive Niagara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • As this is a study of young mothers, women who are 15-24 years of age, speak English, and have a child under the age of 5 will be recruited.

Exclusion Criteria:

  • Only women aged 15-24 years who have a child under the age of five will be eligible. Women must be enrolled in the Strive Niagara program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioural Therapy
The women in this arm will receive a 9-week CBT-based curriculum delivered by Public Health Nurses to help build resilience and optimize mood, anxiety, and emotion regulation while attending a supported school program in Niagara Region.
The transdiagnostic CBT-based curriculum is based on the extensive clinical experience of the research team with young women and those struggling with perinatal mental disorders. The team also has significant expertise delivering CBT for depression and anxiety (including perinatal variants) in groups. The manual was developed by the research team and is based on the state-of-the-art in resilience and CBT interventions in adolescents and young adults (e.g., the Penn Resiliency Program (60), Treatment for Adolescent Depression Study (61)). After it was developed, it was subjected to further scrutiny by public health nurses and STRIVE staff, who have extensive experience working with young mothers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of delivering the group
Time Frame: 12 months
The feasibility of delivering the group will be assessed using simple counts of the number of women who agree to participate
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Beck Depression Inventory
Time Frame: 6 months
The Beck Depression Inventory is a 21-item scale that assesses the emotional, cognitive, and somatic symptoms of depression.
6 months
The Beck Anxiety Inventory
Time Frame: 6 months
The Beck Anxiety Inventory is a 21-item self-report scale that taps generalized anxiety disorder, the most common comorbidity of depression.
6 months
Difficulties in Emotion Regulation Scale
Time Frame: 6 months
The Difficulties in Emotion Regulation Scale is a 36-item measure of this construct validated in adolescents.
6 months
Adult-Adolescent Parenting Inventory
Time Frame: 6 months
The Adult-Adolescent Parenting Inventory-2 is a validated 40-item measure used to assess strengths and weaknesses in child rearing.
6 months
Strengths and Difficulties Questionnaire
Time Frame: 6 months
Impact on behavioural problems of women's other children will be assessed using the Strengths and Difficulties Questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ryan J Van Lieshout, MD, PhD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2018

Primary Completion (Actual)

March 15, 2020

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBT YM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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