Clinical trial NCT03796663: Mindful Parenting and Parent Training Program Study
Official title: Evaluation of the Effectiveness of a Combined Mindful Parenting and Parent Training Program on Children With Disruptive Behavioral Problems and Their Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Behavioral Assessment System for Children - 3 (BASC-3)
timeFrame: Seven months from start of intervention.
measure: Brief Problem Checklist-Parent (BPC-P)
timeFrame: Seven months from start of intervention.
measure: Impairment Rating Scale - Parent/Teacher Version (IRS)
timeFrame: Seven months from start of intervention.
measure: Columbia Impairment Scale (CIS)
timeFrame: Seven months from start of intervention.
measure: Mindfulness In Parenting Questionnaire (MIPQ)
timeFrame: Seven months from start of intervention.
measure: Five-Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Seven months from start of intervention.
measure: Parent-Child Interaction Questionnaire-Revised-Parent and Child Version (PACHIQ-R)
timeFrame: Seven months from start of intervention.
measure: Parenting Scale (PS)
timeFrame: Seven months from start of intervention.
measure: Parent Behavior Inventory (PBI) - Supportive/Engaged Subscale
timeFrame: Seven months from start of intervention.
measure: Family and Peer Process Code (FPP) and Five Observational Lab Tasks
timeFrame: Seven months from start of intervention.
measure: IOWA Conners Rating Scale
timeFrame: Seven months from start of intervention.
Secondary outcomes:
measure: Parent Emotion Regulation Inventory-2 (PERI-2)
timeFrame: Seven months from start of intervention.
measure: Knowledge of Parenting Strategies Scale (KoPSS)
timeFrame: Seven months from start of intervention.
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Seven months from start of intervention.
measure: Berkeley Expressivity Questionnaire (BEQ)
timeFrame: Seven months from start of intervention.
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: Seven months from start of intervention.
measure: Parenting Stress Index-Short Form (PSI-SF)
timeFrame: Seven months from start of intervention.
measure: Fragile Families Aggravation in Parenting Scale
timeFrame: Seven months from start of intervention.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University - Kimball Hall
state: New York
Study officials:
References: