Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02896426
Other study ID # 2016000948/MGH
Secondary ID
Status Terminated
Phase N/A
First received August 31, 2016
Last updated January 30, 2018
Start date September 2016
Est. completion date July 25, 2017

Study information

Verified date January 2018
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Collaborative Problem Solving (CPS) is an evidence-based approach for treating children with behavioral challenges. Unlike traditional models of discipline that use power, control and incentives to facilitate compliance, CPS does not assume that a challenging child lacks motivation for compliance, but instead that the child is motivated to behave well, but simply cannot consistently do so, due to lagging skills in one or more critical neurocognitive domains, such as those related to language and communication skills, attention and working memory skills, emotion- and self-regulation skills, cognitive flexibility skills, and/or social thinking skills. The goal of the intervention is to improve these lagging neurocognitive skills by helping adults and children work toward mutually satisfactory solutions to problems, thereby enhancing flexibility and frustration tolerance in both interaction partners. Any caregiver can use CPS with any child, and CPS can be taught to mental health providers (e.g., therapists, direct care staff), educators (e.g., teachers, administrators), or parents. Common ways to teach CPS to parents include family therapy (one provider teaching one family) or in parent group training (one provider teaching six to ten parents).

Although preschool-aged children have been included in past CPS-related research, they have not been studied separately, and research has not assessed the appropriateness of the current CPS approach for very young children. To address this gap in research, this study will support the development of a parent group curriculum specifically targeting guardians of preschool-aged children, as well as a randomized efficacy trial to evaluate the feasibility, acceptability, and effects of a CPS parent group. Outcome measures from the CPS group will be compared with those from a group that promotes operant behavioral parenting.

Approximately sixty participating guardians will be randomly assigned to attend one of two types of weekly 2-hour groups, each lasting six weeks: either a Collaborative Problem Solving group (N=30; 3 groups) or a Positive Solutions for Families group, a group routinely offered at Head Start programs (N=30; 3 groups). Participants will complete surveys prior to beginning the groups (baseline), upon completion of the group sessions (discharge), and six months after the conclusion of the groups (follow up). Results from these surveys will be compared between groups.


Recruitment information / eligibility

Status Terminated
Enrollment 22
Est. completion date July 25, 2017
Est. primary completion date July 25, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Collaborative Problem Solving
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.
Positive Solutions For Families
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Caplan Foundation for Early Childhood

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Impact of parenting groups on parenting style Parenting Styles and Dimensions Questionnaire (Measures parenting philosophy and includes scores for authoritative style, authoritarian style, and permissive style.) 8 months (changes from baseline, immediately after group, and 6 months after the group)
Secondary Impact of parenting groups on parent emotion regulation Difficulties in Emotion Regulation Scale (Measures emotion regulation skills including nonacceptance of emotional responses, difficulties engaging in goal-directed behaviors, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity.) 8 months (changes from baseline, immediately after group, and 6 months after the group)
Secondary Impact of parenting groups on the parent child relationship Parent Child Relationship Inventory (Measures how parents view the task of parenting and how they feel about their children. Measures parental support, satisfaction with parenting, communication, limit setting, parent response consistency, and parent social desirability.) 8 months (changes from baseline, immediately after group, and 6 months after the group)
Secondary Impact of parenting groups on the parent philosophy Think:Kids Measure of Change Over Time (Measures perceptions of parent-child relationship quality, parenting philosophy, and predictability of youth's challenging behavior.) 8 months (changes from baseline, immediately after group, and 6 months after the group)
Secondary Acceptability of a CPS group for parents of preschool-age children Qualitative interviews at each time point 8 months (changes from baseline, immediately after group, and 6 months after the group)
Secondary Parent satisfaction with a CPS group for preschool-aged children Qualitative interviews at each time point 8 months (changes from baseline, immediately after group, and 6 months after the group)
Secondary Parent satisfaction with a CPS group for preschool-aged children Quantitative parent report of group acceptability at the conclusion of the groups 8 weeks (immediately after conclusion of group)
See also
  Status Clinical Trial Phase
Completed NCT06039462 - Virtual Reality Distraction Therapy in Paediatrics N/A
Completed NCT02145273 - Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children N/A
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT03026335 - Childhood Resiliency Effects for School-wide Treatment in Belize City N/A
Completed NCT05334433 - Child Behavior After Local Anesthetic Injection Using Needless Systems N/A
Recruiting NCT06185413 - Children's Cooperation Denmark: a 3-year System Dynamics Trial N/A
Enrolling by invitation NCT06057090 - Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients? N/A
Terminated NCT04075071 - A Pilot Study of Teacher-Child Interaction Training - Universal in Head Start N/A
Completed NCT05828264 - The Effect of "Quantum-Touch" on Pain, Fear, and Anxiety of the Children N/A
Completed NCT04633434 - Evaluation Study of Talk Parenting Skills N/A
Completed NCT05854355 - Children- Sit Less, Move More (C-SLAMM): Increasing Physical Activity and Decreasing Sedentary Behaviour in Children N/A
Recruiting NCT04627415 - Project PEAK: Early Intervention for ADHD N/A
Completed NCT06052878 - Neurodevelopmental Outcome After Prenatal Anesthesia
Recruiting NCT04107506 - The Supporting Early Learning Study N/A
Recruiting NCT06140017 - Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya N/A
Not yet recruiting NCT06138405 - Dental-Child Interaction Training N/A
Completed NCT03015337 - Relationship of Motor Skill Competency and Physical Fitness to Physical Activity in Elementary School Students N/A
Completed NCT03400566 - Effects of Experiential Learning on Vegetable Intake in Preschool Children N/A
Recruiting NCT06064578 - The Ukrainian Student Problem Solving Project N/A
Active, not recruiting NCT04070131 - Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects N/A