Mindful Parenting and Parent Training Program Study

NCT03796663 | Completed

• 1 other identifier: IRB-FY2019-2401
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Disruptive Behavioral Problems; ADHD; Oppositional Defiant Disorder; Conduct Disorder; Mindfulness; Mindful Parenting; Behavioral Parent Training

Outcome Measures

Primary Outcomes (11)

• Behavioral Assessment System for Children - 3 (BASC-3)

  A well-standardized, multidimensional approach to evaluating the behavior of children. For this measure we will be looking at several subscales, including Hyperactivity, Agression, Conduct Problems, Externalizing Problems, Attention Problems, Anger Control, and Emotional Self-Control. For each subscale, a T-score is obtained using norms; T-scores range from 20 to 120, with higher T-Scores indicating a worse outcome/greater impairment.

  Seven months from start of intervention.

• Brief Problem Checklist-Parent (BPC-P)

  A measure designed to periodically assess the clinical progress of a child over the course of psychological treatment, specifically measuring the severity of internalizing and externalizing problems found in children. The scale scores of the BPC are based on the raw sum of item responses, each of which ranges from 0 to 2. Thus, scores on the six-item Internalizing and Externalizing scales each range from 0 to 12, and scores on the Total Problems scale range from 0 to 24, with higher scores indicating increased problem levels.

  Seven months from start of intervention.

• Impairment Rating Scale - Parent/Teacher Version (IRS)

  A multidimensional measure that assesses functioning across domains. Specifically, the IRS qualifies and quantifies impairment present in a child's life, both in school and non-school settings. No total or subscale scores are calculated, each item of this measure is considered individually.

  Seven months from start of intervention.

• Columbia Impairment Scale (CIS)

  Measures 4 major areas of functioning: interpersonal relations, broad psychopathological domains, functioning in job or schoolwork, and use of leisure time. Items are scored on a 5-point Likert-type scale ranging from 0 ("no problem") to 4 ("a very big problem"). "Not applicable/do not know" is scored as a 5. Sum scores can range from 0 to 52, with higher scores indicating greater impairment.

  Seven months from start of intervention.

• Mindfulness In Parenting Questionnaire (MIPQ)

  Assesses two factors of mindfulness in parenting: Being in the moment with the child and mindful discipline. For all 28 items, parents rate themselves for each item using the following scale: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = almost always. Standard Scores are obtained for each subscale by summing up the items that make up that subscale and then using a conversion table.

  Seven months from start of intervention.

• Five-Facet Mindfulness Questionnaire (FFMQ)

  A widely used scale to assess the tendency to be mindful in daily life.The FFMQ is a 39-item self-report measure that evaluates five facets of the tendency to be mindful in daily life and consists of the five subscales of Observing (scores range from 8 to 40), Describing (scores range from 8 to 40), Acting with Awareness (scores range from 8 to 40), Nonreactivity (scores range from 7 to 35), and Nonjudging (scores range from 8 to 40). The scale uses a five-point Likert scale for all items, where 1 = never or very rarely true and 5 = very often or always true. For all subscales a higher score is indicative of a greater tendency to be mindful in that particular facet. The two subscales are Mindful Discipline and Being in the Moment with the Child; for both scales, Standard scores between 90 and 110 fall within the average range, with higher scores indicating greater levels of mindful parenting.

  Seven months from start of intervention.

• Parent-Child Interaction Questionnaire-Revised-Parent and Child Version (PACHIQ-R)

  Assesses how parents view their relationship with their children (and how children view their relationship with their parents). There are 25 items split into two parts, part 1 with items 1 through 14 and part 2 with items 15 through 25 in the PACHIQ-R questionnaire. The Total Score ranges from 25 to 125. A high Total Score is indicative for a positive relationship.

  Seven months from start of intervention.

• Parenting Scale (PS)

  Self-report measure of dysfunctional parenting in discipline situations. The measure consists of 30 items, and each item receives a 1-7 score. The Total Score is calculated by averaging the responses on all 30 items and ranges from 1 to 7. There are 4 subscales - Laxness, Overreactivity, Verbosity, and Other - the scores for which are also calculated by averaging the responses on the items that make up each subscale. The score for each subscale ranges from 1 to 7. For each score, lower numbers indicate a higher probability of using effective discipline strategies and higher numbers indicate a higher probability of using ineffective discipline strategies.

  Seven months from start of intervention.

• Parent Behavior Inventory (PBI) - Supportive/Engaged Subscale

  Measure of parenting behavior that contains two independent scales, Supportive/Engaged and Hostile/Coercive. We will only be looking at the Supportive/Engaged Subscale, which measures levels of supportive/engagement parenting behavior. For this subscale, parents rate themselves for each item using the following scale: 0 = not at all true, 1 = a little true, 2 = somewhat true, 3= moderately true, 4 = quite a bit true, 5 = very true. To obtain To obtain the Subscale score, the responses to each item are summed together; the score can range from 0 to 50. A higher score is indicative of parents engaging in more supportive or engaged parenting behaviors.

  Seven months from start of intervention.

• Family and Peer Process Code (FPP) and Five Observational Lab Tasks

  Parenting practices will be assessed using data derived from 35 min of videotaped parent-child interaction. These interactions will sample five different tasks. Trained observers blind to intervention assignment will then code the tapes of the family interaction using the FPP and will make global ratings.

  Seven months from start of intervention.

• IOWA Conners Rating Scale

  The first half of the measure is designed to assess inattentive-impulsive-overactive behaviors while the second half captures behaviors related to oppositional-defiant activity. All 10 items of the measure are scored using a four point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3). The first five items on the IOWA are designed to measure inattentive-impulsive-overactive (IO Subscale) behaviors and the second five items are designed to measure oppositional-defiant (OD Subscale) behaviors. For both scales, higher scores indicate greater impairment and the scores can range from 0 to 15.

  Seven months from start of intervention.

Secondary Outcomes (7)

• Parent Emotion Regulation Inventory-2 (PERI-2)

  Seven months from start of intervention.

• Knowledge of Parenting Strategies Scale (KoPSS)

  Seven months from start of intervention.

• Emotion Regulation Questionnaire (ERQ)

  Seven months from start of intervention.

• Berkeley Expressivity Questionnaire (BEQ)

  Seven months from start of intervention.

• Positive and Negative Affect Scale (PANAS)

  Seven months from start of intervention.

Study Arms (2)

Mindful Parenting Only

ACTIVE COMPARATOR

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).

Behavioral: Mindful Parenting Program

Mindful Parenting and BPT Combined

EXPERIMENTAL

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.

Behavioral: Mindful Parenting Program; Behavioral: MATCH BPT Program

Interventions

Mindful Parenting Program 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 Only; Mindful Parenting and BPT Combined

MATCH BPT Program 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.

Mindful Parenting and BPT Combined

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• the child participant must be between the ages of 6 and 11 years old at baseline/time of pretreatment data collection;
• 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,
• ), 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.

You may not qualify if:

• There is evidence of significant developmental delay or psychosis that impacts the child's ability to fully engage in the intervention;
• 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);
• if the parent and/or child are not fluent English speakers;
• if the family is currently enrolled in any type of behavioral parent or parent management training program; and
• 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.

Sponsors & Collaborators

• New York University: lead

Study Sites (1)

New York University - Kimball Hall

New York, New York, 10003, United States

Location

Related Links

• FACES Lab - Study Website

MeSH Terms

Conditions

Problem Behavior; Attention Deficit Disorder with Hyperactivity; Oppositional Defiant Disorder; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 8, 2019
• Study Start: December 18, 2018
• Primary Completion: October 31, 2020
• Study Completion: June 7, 2021
• Last Updated: November 2, 2022

Record last verified: 2021-06

Locations

US (1)