Mindful Parenting and Parent Training Program Study

NCT ID: NCT03796663

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2021-06-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Mindful Parenting and Parent Training Study will be investigating the combination of Bögels and Restifo's (2014) Mindful Parenting Program and Chorpita and Weisz's (2009) Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH) Program, specifically the BPT module. The Mindful Parenting Program is an adaptation for parents of the Mindfulness-Based Cognitive Therapy, and the Mindfulness-Based Stress Reduction program; the program will consist of 7-weekly 2.5-hour parent group sessions. Following the completion of the Mindful Parenting group sessions, half of the participants will be randomly selected to receive individually-implemented MATCH BPT sessions, which will consist of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 1.5-hour sessions. The other half of families will have the opportunity to also receive the MATCH BPT program following the completion of data collection.

Both evaluation and treatment services will be offered at no cost to study participants. Parents, children, and teachers will also be offered monetary incentive to thank them for their time and effort completing study related assessments throughout the course of the study to determine if the combination of the Mindful Parenting Program with BPT improves functioning in children with disruptive behavioral problems, as well as the parent-child relationship and the parent's acquisition and enactment of the skills they learn in BPT.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disruptive Behavior Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder Conduct Disorder Disruptive Behavior Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants will receive the Mindful Parenting program at the start of their involvement in the study. Following the completion of the Mindful Parenting group sessions, half of the participants will be randomly selected to receive individually-implemented MATCH BPT sessions. The other half of families will have the opportunity to also receive the MATCH BPT program following the completion of data collection.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindful Parenting Only

Participants in this arm will receive only the Mindful Parenting Program at the start of the study. Bögels and Restifo's (2014) Mindful Parenting Program is an adaptation for parents of MBCT, and MBSR; the program will consist of 7-weekly 2.5-hour parent group sessions. In the program, parents learn to apply the skills of mindfulness to themselves and to their experience of parenting their children.

Following the completion of the Mindful Parenting Sessions, participants in this arm will be asked continue to participate in data collection for the post-intervention assessment time point (i.e. 8 weeks after the completion of the Mindful Parenting group sessions) and for the 2-month follow up assessment time point (i.e. 16 weeks after the completion of the Mindful Parenting group sessions). After they have completed both assessments, they will be offered the opportunity to participate in the MATCH BPT program if they so choose (no data will be collected).

Group Type ACTIVE_COMPARATOR

Mindful Parenting Program

Intervention Type BEHAVIORAL

The Mindful Parenting Program consists of 7, 2.5 hour weekly group sessions. In the program, parents learn to apply the skills of mindfulness to themselves and to their experience of parenting their children. Parents are introduced to formal meditation practices, including the bodyscan; choiceless awareness; mindful walking; and yoga. They are also introduced to mindfulness of everyday activities from the beginning of the sessions, with an added focus on day-to-day parenting and family activities. Additionally, short self-compassion practices occur throughout the weekly sessions, culminating in the teaching of formal loving-kindness meditation.

Additionally, the program encourages parents to engage in "home practice", where parents can experience and practice many of the new skills they are learning. This includes both formal, longer meditation practices, as well as shorter practices, which can occur throughout the day, such as mindfulness of daily routines.

Mindful Parenting and BPT Combined

Participants in this arm will receive the Mindful Parenting Program at the start of the study, which will consist of 7-weekly 2.5-hour parent group sessions. In the program, parents learn to apply the skills of mindfulness to themselves and to their experience of parenting their children.

Following the completion of the Mindful Parenting Sessions, participants in this arm will receive receive individually-implemented MATCH BPT sessions, which will consist of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 1 hour sessions. The MATCH manual is comprised of 33 modules (i.e. coping, giving effective instructions, learning to relax, etc.). For the purpose of this study we will be utilizing the section on BPT, which consists of 12 modules with corresponding handouts and worksheets.

Group Type EXPERIMENTAL

Mindful Parenting Program

Intervention Type BEHAVIORAL

The Mindful Parenting Program consists of 7, 2.5 hour weekly group sessions. In the program, parents learn to apply the skills of mindfulness to themselves and to their experience of parenting their children. Parents are introduced to formal meditation practices, including the bodyscan; choiceless awareness; mindful walking; and yoga. They are also introduced to mindfulness of everyday activities from the beginning of the sessions, with an added focus on day-to-day parenting and family activities. Additionally, short self-compassion practices occur throughout the weekly sessions, culminating in the teaching of formal loving-kindness meditation.

Additionally, the program encourages parents to engage in "home practice", where parents can experience and practice many of the new skills they are learning. This includes both formal, longer meditation practices, as well as shorter practices, which can occur throughout the day, such as mindfulness of daily routines.

MATCH BPT Program

Intervention Type BEHAVIORAL

The MATCH BPT Program consists of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 60 minute individually-implemented sessions.The sessions will consist of the coach obtaining and reviewing weekly assignments completed by the parent, followed by activities and discussions that focus on a particular parenting skill (i.e. praise, active ignoring, giving effective instructions). The discussions will emphasize benefits and possible problems that the parent may encounter throughout the week while implementing the new skill. The coach will assign to the parent a practice assignment to further encourage use of the concept.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindful Parenting Program

The Mindful Parenting Program consists of 7, 2.5 hour weekly group sessions. In the program, parents learn to apply the skills of mindfulness to themselves and to their experience of parenting their children. Parents are introduced to formal meditation practices, including the bodyscan; choiceless awareness; mindful walking; and yoga. They are also introduced to mindfulness of everyday activities from the beginning of the sessions, with an added focus on day-to-day parenting and family activities. Additionally, short self-compassion practices occur throughout the weekly sessions, culminating in the teaching of formal loving-kindness meditation.

Additionally, the program encourages parents to engage in "home practice", where parents can experience and practice many of the new skills they are learning. This includes both formal, longer meditation practices, as well as shorter practices, which can occur throughout the day, such as mindfulness of daily routines.

Intervention Type BEHAVIORAL

MATCH BPT Program

The MATCH BPT Program consists of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 60 minute individually-implemented sessions.The sessions will consist of the coach obtaining and reviewing weekly assignments completed by the parent, followed by activities and discussions that focus on a particular parenting skill (i.e. praise, active ignoring, giving effective instructions). The discussions will emphasize benefits and possible problems that the parent may encounter throughout the week while implementing the new skill. The coach will assign to the parent a practice assignment to further encourage use of the concept.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. the child participant must be between the ages of 6 and 11 years old at baseline/time of pretreatment data collection;
2. he/she must have an elevated score (i.e. a t-score of 60 or greater) on one or more of the Externalizing Problems clinical scales (i.e. Hyperactivity, Aggression, and Conduct Problems) or on the Attention Problems clinical scale of the Behavior Assessment System for Children 3rd Edition - Parent Report (BASC-3; Reynolds \& Kamphaus,

2015), as assessed during the intake assessment for the study; 3) both the parent and child participants must be fluent English speakers, and; 4) the parent participant(s) must be available to attend weekly treatment sessions and assessments for up to 26 weeks at New York University - Kimball Hall.

Exclusion Criteria

1. There is evidence of significant developmental delay or psychosis that impacts the child's ability to fully engage in the intervention;
2. The youth or parent presents with emergency psychiatric needs that require services beyond that which can be managed within this intervention format (e.g. hospitalization, specialized placement outside the home);
3. if the parent and/or child are not fluent English speakers;
4. if the family is currently enrolled in any type of behavioral parent or parent management training program; and
5. if the child has an estimated Full Scale IQ below 80, based on completing two subtests of the Wechsler Abbreviated Scale of Intelligence, Second Edition during the intake assessment for the study.
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

New York University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New York University - Kimball Hall

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-FY2019-2401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Telehealth BPT in DBP Practice
NCT05301933 COMPLETED NA
Connecticut Child STEPs
NCT03153904 COMPLETED NA