NCT02896426

Brief Summary

The main objectives of this study are to evaluate the feasibility, acceptability, and effects of a CPS parent group on outcomes for a sample of parents of children ages 3 to 5 compared to outcomes after attending a parenting group that promotes behavioral (operant) parenting. We hypothesize that guardians in the CPS group will report a better understanding of how neurocognitive skills relate to children's behaviors, greater improvements in child functioning and behavior, and greater reductions in parents' stress than those in the comparison group.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

August 31, 2016

Last Update Submit

January 30, 2018

Conditions

Keywords

Parent trainingPreschoolersBehavior problemsOppositional Defiant DisorderODDConduct DisorderCDChildrenParentingCollaborative Problem SolvingCPSDisruptive behavior

Outcome Measures

Primary Outcomes (1)

  • Feasibility of a CPS group for parents of preschool-age children

    Therapy Attitude Inventory (The TAI is a self-report questionnaire that we will use to measure satisfaction with the parenting groups. We will compare the scores on this measure between the two groups.)

    6 months (immediately after group and 6 months after the group)

Secondary Outcomes (7)

  • Impact of parenting groups on parenting style

    8 months (changes from baseline, immediately after group, and 6 months after the group)

  • Impact of parenting groups on parent emotion regulation

    8 months (changes from baseline, immediately after group, and 6 months after the group)

  • Impact of parenting groups on the parent child relationship

    8 months (changes from baseline, immediately after group, and 6 months after the group)

  • Impact of parenting groups on the parent philosophy

    8 months (changes from baseline, immediately after group, and 6 months after the group)

  • Acceptability of a CPS group for parents of preschool-age children

    8 months (changes from baseline, immediately after group, and 6 months after the group)

  • +2 more secondary outcomes

Study Arms (2)

Collaborative Problem Solving

EXPERIMENTAL

Participants will attend parent group sessions led by trained group leaders and learn the Collaborative Problem Solving approach.

Behavioral: Collaborative Problem Solving

Positive Solutions For Families

ACTIVE COMPARATOR

Participants will attend parent group sessions and learn the Positive Solutions for Families approach, a group that is usually offered by Head Start.

Behavioral: Positive Solutions For Families

Interventions

CPS is an approach for understanding and reducing challenging behavior in youth. Under CPS, caregivers are taught to understand and identify the specific neurocognitive skill deficits that underlie their child's challenging behavior. Then the caregivers are taught to interact with the child in a way that solves chronic behavior problems while building the lagging neurocognitive skills to avoid future problems.

Also known as: CPS
Collaborative Problem Solving

Positive Solutions for Families groups provide information for families on how to promote children's social and emotional skills, understand their problem behavior, and use positive approaches to help children learn appropriate behavior.

Positive Solutions For Families

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Guardian of a child between the ages of three and five currently enrolled at participating Head Start center
  • Speaking and writing English at level necessary to complete study requirements

You may not qualify if:

  • A diagnosis of significant Autism that currently impacts day to day functioning
  • A diagnosis of a psychotic disorder including schizophrenia, schizoaffective disorder, schizophreniform disorder
  • An intellectual disability that impairs day to day functioning
  • Participation in a similar parenting group at the Head Start site within the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Child BehaviorProblem BehaviorMental DisordersOppositional Defiant DisorderConduct Disorder

Condition Hierarchy (Ancestors)

BehaviorBehavioral SymptomsAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Study Officials

  • Alisha R Pollastri, Ph. D.

    Think:Kids at Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research and Evaluation, Think:Kids

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 12, 2016

Study Start

September 1, 2016

Primary Completion

July 25, 2017

Study Completion

July 25, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share