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CompletedNCT03329144CBTYMUpdated Apr 14, 2021

CBT for Young Mothers

An interventional study of Cognitive Behavioural Therapy in Anxiety, Depression and Emotion Regulation, sponsored by McMaster University. Completed at 1 site in Canada. Open to female participants aged 15 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-14.

Sponsored by McMaster University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
15 Years to 24 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Anxiety
  • Depression
  • Emotion Regulation

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Keywords

  • Young mother
  • Depression
  • Anxiety
  • Resilience
  • Emotion regulation
  • Parenting
  • CBT
03

Who can participate

Ages eligible
15 Years to 24 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • 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.

    Behavioral: Cognitive Behavioural Therapy

Interventions

  • BehavioralCognitive Behavioural Therapy

    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.

05

What researchers measure

Primary outcomes

  1. Feasibility of delivering the group

    The feasibility of delivering the group will be assessed using simple counts of the number of women who agree to participate

    Time frame: 12 months

Secondary outcomes

  1. The Beck Depression Inventory

    The Beck Depression Inventory is a 21-item scale that assesses the emotional, cognitive, and somatic symptoms of depression.

    Time frame: 6 months

  2. The Beck Anxiety Inventory

    The Beck Anxiety Inventory is a 21-item self-report scale that taps generalized anxiety disorder, the most common comorbidity of depression.

    Time frame: 6 months

  3. Difficulties in Emotion Regulation Scale

    The Difficulties in Emotion Regulation Scale is a 36-item measure of this construct validated in adolescents.

    Time frame: 6 months

  4. Adult-Adolescent Parenting Inventory

    The Adult-Adolescent Parenting Inventory-2 is a validated 40-item measure used to assess strengths and weaknesses in child rearing.

    Time frame: 6 months

  5. Strengths and Difficulties Questionnaire

    Impact on behavioural problems of women's other children will be assessed using the Strengths and Difficulties Questionnaire

    Time frame: 6 months

06

Study locations

1 site
  • Strive Niagara
    Welland, Ontario L3B3W9, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03329144
Lead sponsor
McMaster University
Collaborators
Strive Niagara, Niagara Region Public Health
Responsible party
Ryan Van Lieshout, MD, PhD (Assistant Professor, Department of Psychiatry and Behavioural Neurosciences, McMaster University) — Principal investigator
First posted
Nov 1, 2017
Start date
Jan 3, 2018
Primary completion
Mar 15, 2020
Completion
Mar 15, 2020
Last update
Apr 14, 2021

Study contacts

Ryan J Van Lieshout, MD, PhD
principal investigator · McMaster University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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