Child BehaviorNCT02896426
Collaborative Problem Solving vs. Positive Solutions for Families in Preschool Parent Groups
A study testing Collaborative Problem Solving and Positive Solutions For Families in people with Child Behavior and Problem Behavior, run by Massachusetts General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Behavior, Problem Behavior, Family Conflict
- What is being tested?
- Collaborative Problem Solving and Positive Solutions For Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 25 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Comparison of Collaborative Problem Solving (CPS) and Positive Solutions for Families Groups for Parents of Head Start Preschoolers
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.
Read the detailed 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.
- Conditions
- Child Behavior, Problem Behavior, Family Conflict
- Being tested
- Collaborative Problem Solving, Positive Solutions For Families
- Keywords
- Parent training, Preschoolers, Behavior problems, Oppositional Defiant Disorder, ODD, Conduct Disorder, CD, Children, Parenting, Collaborative Problem Solving, CPS, Disruptive behavior
- Medical subject headings
- Child Behavior, Problem Behavior, Mental Disorders, Oppositional Defiant Disorder, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Problem SolvingBehavioural
Also called CPS
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 FamiliesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Problem Solving | Experimental | Participants will attend parent group sessions led by trained group leaders and learn the Collaborative Problem Solving approach. Receives: 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. Receives: Behavioral: Positive Solutions For Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 6 months (immediately after group and 6 months after the group)
Secondary outcomes (7)
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.)
Measured: 8 months (changes from baseline, immediately after group, and 6 months after the group)
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.)
Measured: 8 months (changes from baseline, immediately after group, and 6 months after the group)
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.)
Measured: 8 months (changes from baseline, immediately after group, and 6 months after the group)
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.)
Measured: 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
Qualitative interviews at each time point
Measured: 8 months (changes from baseline, immediately after group, and 6 months after the group)
Parent satisfaction with a CPS group for preschool-aged children
Qualitative interviews at each time point
Measured: 8 months (changes from baseline, immediately after group, and 6 months after the group)
Parent satisfaction with a CPS group for preschool-aged children
Quantitative parent report of group acceptability at the conclusion of the groups
Measured: 8 weeks (immediately after conclusion of group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion25 Jul 2017
- Study completion25 Jul 2017
Why it stopped: Study halted prematurely due to low recruitment and will not resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Caplan Foundation for Early Childhood
- Responsible party
- Principal investigator, Alisha R Pollastri, Massachusetts General Hospital
- Investigators
- Alisha R Pollastri, Ph. D., Principal investigator, Think:Kids at Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896426
- Sponsor's protocol ID
- 2016000948/MGH
- Status last verified
- Jan 2018
- First submitted
- 31 Aug 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Collaborative Problem Solving (CPS) and Positive Solutions for Families Groups for Parents of Head Start Preschoolers
- ClinicalTrials.gov ID
- NCT02896426
- Acronym / sponsor ID
- 2016000948/MGH
- Conditions
- Child Behavior, Problem Behavior, Family Conflict
- Keywords
- Parent training, Preschoolers, Behavior problems, Oppositional Defiant Disorder, ODD, Conduct Disorder, CD, Children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely due to low recruitment and will not resume.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Caplan Foundation for Early Childhood
- Study start
- Sep 2016
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Problem Solving | Experimental | Behavioral: Collaborative Problem SolvingParticipants will attend parent group sessions led by trained group leaders and learn the Collaborative Problem Solving approach. |
| Positive Solutions For Families | Active comparator | Behavioral: Positive Solutions For FamiliesParticipants will attend parent group sessions and learn the Positive Solutions for Families approach, a group that is usually offered by Head Start. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative Problem SolvingAlso: CPSCPS 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. | Behavioural | Collaborative Problem Solving |
| Positive Solutions For FamiliesPositive 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. | Behavioural | Positive Solutions For Families |
Primary outcome
Feasibility of a CPS group for parents of preschool-age children
Time frame: 6 months (immediately after group and 6 months after the group)
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.)
7 secondary outcomes
Impact of parenting groups on parenting style
Time frame: 8 months (changes from baseline, immediately after group, and 6 months after the group)
Impact of parenting groups on parent emotion regulation
Time frame: 8 months (changes from baseline, immediately after group, and 6 months after the group)
Impact of parenting groups on the parent child relationship
Time frame: 8 months (changes from baseline, immediately after group, and 6 months after the group)
Impact of parenting groups on the parent philosophy
Time frame: 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
Time frame: 8 months (changes from baseline, immediately after group, and 6 months after the group)
Parent satisfaction with a CPS group for preschool-aged children
Time frame: 8 months (changes from baseline, immediately after group, and 6 months after the group)
Parent satisfaction with a CPS group for preschool-aged children
Time frame: 8 weeks (immediately after conclusion of group)
Results and safety
The study was stopped early (reason given: Study halted prematurely due to low recruitment and will not resume.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- The approach being studied here, Collaborative Problem Solving, is updated and disseminated from Think:Kids at Massachusetts General Hospital.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alisha R Pollastri, Ph. D. principal investigator
Think:Kids at Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Problem Solving and Positive Solutions For Families in people with Child Behavior and Problem Behavior, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study halted prematurely due to low recruitment and will not resume.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a CPS group for parents of preschool-age children (time frame: 6 months (immediately after group and 6 months after the group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.