120 Participants Needed

Stress Management Strategies for Parent-Child Relationships

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Florida International University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The goal of this randomized study is to learn if adding three additional parent training sessions (focused on alleviating parental stress) to an already well-established treatment (School Readiness Parenting Program \[SRPP\]) in improving outcomes up to 6- and 12-months later for families of children with disruptive behavior disorders. The main questions it aims to answer are: The primary objective of this protocol is to evaluate the effects of three additional cognitive behavioral therapy (CBT) based parent training sessions to the SRPP to reduce parent stress and improve parent-child interactions. The secondary objective of this protocol is to evaluate the behavioral, emotional, and physical health-based functioning among young children with ADHD. Researchers will compare families who receive the SRPP alone to families who receive the SRPP + the three additional CBT focused sessions. Parents will be sent surveys to complete prior to the baseline assessment via REDCap (online). Parent and child participants will undergo 2 hours of baseline assessments evaluating behavioral, cognitive, and academic functioning as well as parent-child interactions. Parents will provide contact information for their child's teacher and the teacher will sent three surveys to complete online via REDCap.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on parent training sessions and does not mention medication changes.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy (CBT) for improving parent-child relationships?

Research shows that Cognitive Behavioral Therapy (CBT) is effective in treating anxiety and trauma in children, especially when parents are involved in the therapy process. Studies indicate that parent participation in CBT can enhance the overall effectiveness of the treatment, leading to better outcomes for children.12345

Is Cognitive Behavioral Therapy (CBT) safe for use in humans, particularly in parent-child relationships?

Cognitive Behavioral Therapy (CBT) is generally considered safe for humans, including children and families. Studies have shown high satisfaction among caregivers and positive outcomes in managing anxiety and trauma, indicating that it is a well-tolerated treatment.46789

How does the Stress Management Strategies for Parent-Child Relationships treatment differ from other treatments for parent-child relationship stress?

This treatment is unique because it focuses on mindfulness-based approaches to improve parent-child relationships, which can enhance communication and reduce stress in both parents and children. Unlike traditional parenting programs that may focus on behavior management, this approach emphasizes emotional awareness and mindful interactions, making it particularly effective for families dealing with developmental disorders or high stress levels.310111213

Eligibility Criteria

This trial is for parents of children with disruptive behavior disorders like ADHD. Participants should be interested in improving their parenting skills and reducing stress. They must have access to the internet to complete online surveys.

Inclusion Criteria

At-risk clinical range on the BASC-Preschool Version (per parent and teacher report) or clinical diagnosis of Attention-Deficit/Hyperactivity Disorder and/or Oppositional Defiant Disorder based on the Disruptive Behavior Disorders Scale or the Diagnostic Interview Schedule for Children
Parent and teacher report of significant levels of impairment at home and at school on the Impairment Rating Scale

Exclusion Criteria

Significant sensory impairments (e.g. deafness, blindness)
Families with current Department of Children and Family (DCYF) involvement
I have a condition like cerebral palsy that affects my ability to move.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Parents and children undergo 2 hours of baseline assessments evaluating behavioral, cognitive, and academic functioning as well as parent-child interactions

1 day
1 visit (in-person)

Treatment

Participants receive a 7-week behavioral treatment and are randomized to either the School Readiness Parenting Program alone or with additional CBT sessions

7 weeks
Weekly sessions (1.5 to 2 hours each)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month and 12-month intervals

12 months
2 visits (in-person)

Treatment Details

Interventions

  • Cognitive Behavioral Therapy (CBT)
Trial OverviewThe study tests if adding three extra CBT-based sessions focused on stress management to the School Readiness Parenting Program helps reduce parent stress and improve interactions with their child, compared to just SRPP alone.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: School Readiness Parenting Program + Cognitive Behavioral TherapyExperimental Treatment3 Interventions
For those randomly assigned to the additional parenting stress modules, parents will receive the same SRPP as well as three additional modules to target parenting stress. The modules will incorporate practices based on Cognitive-Behavioral Therapy (CBT).
Group II: Traditional School Readiness Parenting ProgramActive Control2 Interventions
Parents will be required to attend a School Readiness Parenting Program for 1.5 to 2 hours weekly. Sessions include behavioral management strategies and school readiness. Behavior management strategies are delivered to the entire group via a Community Parent Education Program (COPE) style modeling problem solving approach; parents contribute to the didactic discussion. The behavioral management content is derived from Parent-Child Interaction Therapy (PCIT).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials
114
Recruited
19,400+

Findings from Research

In a study of 82 children aged 7-12 receiving parent-led cognitive behavioral therapy after trauma, lower educational achievement in parents was linked to a higher likelihood of non-completion of the treatment.
Unexpectedly, higher emotional reactions from parents regarding their child's trauma and greater perceived social support were associated with non-response, suggesting that parents may need additional emotional support to effectively help their children.
Parent-led stepped care for traumatised children: parental factors that predict treatment completion and response.Fagermoen, EM., Skjærvø, I., Jensen, TK., et al.[2023]
Cognitive Behaviour Therapy (CBT) is recognized as a promising treatment for children and adolescents with psychiatric disorders, supported by a historical development and evidence of its effectiveness.
The article discusses both the current challenges and future potential of CBT, suggesting it will remain a key therapeutic option for mental health professionals working with young people.
Jack Tizard Lecture: Cognitive Behaviour Therapies for Children: Passing Fashion or Here to Stay?Graham, P.[2020]
In a study involving 53 children with anxiety disorders, specific parent training techniques in family-based cognitive-behavioral therapy (FCBT) significantly improved children's overall functioning, particularly through parental anxiety management and transferring control from therapist to parent.
However, these parent training techniques did not show a significant impact on reducing child anxiety levels, indicating that while they may enhance global functioning, they might not directly address anxiety symptoms.
Exploring the role of parent training in the treatment of childhood anxiety.Khanna, MS., Kendall, PC.[2018]

References

Parent-led stepped care for traumatised children: parental factors that predict treatment completion and response. [2023]
Jack Tizard Lecture: Cognitive Behaviour Therapies for Children: Passing Fashion or Here to Stay? [2020]
Exploring the role of parent training in the treatment of childhood anxiety. [2018]
Child versus family cognitive-behavioral therapy in clinically anxious youth: an efficacy and partial effectiveness study. [2022]
The effects of parent participation on child psychotherapy outcome: a meta-analytic review. [2022]
An innovative child CBT training model for community mental health practitioners in Ontario. [2018]
Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent-child dyads with anxiety disorders: a mixed-methods pilot trial protocol. [2021]
Caregiver Satisfaction and Perceptions of Trauma-Focused Cognitive Behavioral Therapy. [2022]
Trauma-focused cognitive behavioral therapy for children and families. [2019]
[Parental involvement in cognitive-behavioral therapy for children with anxiety disorders]. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Parenting-focused mindfulness intervention reduces stress and improves parenting in highly-stressed mothers of adolescents. [2022]
[Parent-child relationships and mindfulness]. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Effects of parenting program components on parental stress: A systematic review and component network meta-analysis. [2023]