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Completed

NCT Number: NCT03329144

CBT for Young Mothers

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.

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Key information

Age range

15 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Strive Niagara

Welland, Ontario, L3B3W9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Niagara Region Public Health
  • Strive Niagara

Registry information

Official study title

Building Resilience in Young Mothers: A CBT-Based Curriculum

Acronym: CBTYM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2017
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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