Sleep ProblemsPhase 2NCT00133055
Parenting Matters: Helping Parents With Young Children
A Phase 2 study testing Self-help treatment booklet and telephone support in people with Sleep Problems and Behavior Problems, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
Sleep and discipline problems are the most common problems for parents of young children (ages 2 to 5 years old) and are the two concerns with the strongest relations to future child behavior problems. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Problems, Behavior Problems, Child Behavior
- What is being tested?
- Self-help treatment booklet and telephone support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to Mar 2009
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent (primary caregiver) of a 2-5 year old child
- Attending a medical appointment at a family medical practice
- Phone in home
- Parent concerned about child's sleep and/or discipline
- Parent interested in participating in a treatment study
Who cannot join
- Parent non-English speaking
- Child with significant physical or developmental disability
- Parent's only sleep concern is in regards to a physiological sleep disorder (e.g. sleep apnea, snoring) or bedwetting
- No phone
Trial locations and contacts
1 site in 1 country.
About this study
Sleep and discipline problems are the most common problems for parents of young children (ages 2 to 5 years old) and are the two concerns with the strongest relations to future child behavior problems. The Parenting Matters program combines treatment booklets and telephone support to help parents deal with sleep or discipline problems. Parents with concerns and who are interested in the study are identified during a visit to their family physician. We, the investigators at the University of Western Ontario, expect that parents receiving treatment booklets, along with usual care by their family physician, will have greater reductions in their child's sleep or discipline problems, improved parenting practices, and greater reductions in child behaviour problems after receiving the Parenting Matters intervention, compared to parents receiving usual medical care.
Read the detailed description
About 1 in 5 young children (ages 2 to 5 years) has a significant psychosocial problem, but over 80% do not receive treatment. Without treatment, up to half of these children will have problems into childhood and adolescence. New methods of treating and preventing children's psychosocial problems are needed.
Sleep and discipline problems (or child non-compliance) are the most common problems for parents of young children, and are the two concerns with the strongest relations to future child behavior problems. Further, parenting practices have consistently been linked to the development of psychosocial problems. The Parenting Matters program combines treatment booklets and telephone support to help parents with sleep or discipline problems among young children.
Objectives:
- Test the efficacy of the Parenting Matters program interventions for sleeping and bedtime behaviors (Trial 1), and discipline (Trial 2) in reducing problem-specific outcomes.
- Test the effects of the Parenting Matters program interventions for parents who are concerned about both their children's sleep and discipline (Trial 3) in reducing problem-specific outcomes related to sleep (Group 1) and discipline problems (Group 2) will be tested.
- Test the efficacy of the Parenting Matters program in improving parenting practices.
- Test the efficacy of the Parenting Matters program in reducing child behaviour problems in general.
- Examine predictors of treatment success.
Method:
All parents of 2 to 5 year-olds seen in a family practice for a routine appointment are asked to complete a psychosocial concerns checklist. Parents who have concerns regarding their child's sleep (Trial 1), how to discipline their child (Trial 2), or concerns about both their child's sleep and discipline (Trial 3), and meet the other study criteria, are invited to take part in the study. Mailed baseline assessment packages assess children's behavior, parenting practices and potential predictors of treatment success.
Parents are randomized to usual care, or the Parenting Matters program along with usual care. The Parenting Matters program includes treatment booklets addressing either sleep or discipline problems, and telephone coach support (3 calls over 6 weeks).
Primary outcomes are parents' ratings of their children's sleep or discipline problems measured at post-treatment (7 weeks after baseline). Parents repeat assessment packages at 3- and 6-month follow-ups.
Goals \& Relevance:
This research addresses the need for new ways of providing early interventions for young children that:
- reach the largest number of individuals in need;
- are cost effective; and
- time efficient.
By addressing the most common issues facing parents of young children, it engages parents in areas of direct relevance to them. The program focuses on parenting practices thereby building family strengths that may have a lasting impact on child development. Collaboration with family physicians builds on the ongoing positive relationships between parents and family physicians and provides a mechanism to reach a significant proportion of young children.
- Conditions
- Sleep Problems, Behavior Problems, Child Behavior
- Being tested
- Self-help treatment booklet and telephone support, Usual care by a family physician
- Keywords
- parenting, sleep problems, behavior problems, brief intervention, self-help, preschool-age children, psychosocial
- Medical subject headings
- Parasomnias, Mental Disorders, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help treatment booklet and telephone supportBehavioural
The Parenting Matters treatment program consisted of a self-help treatment booklet and two telephone coaching calls from a paraprofessional telephone coach at Weeks 2 and 5 of the program. Two booklets were used in the three trials; one addressed sleep issues and the second discipline problems.
Usual care by a family physicianBehavioural
Parents in the usual care condition were told to continue with care from their family physician and/or any other treatment recommended by the physician.
| Study group | Role | What they receive |
|---|---|---|
| Treatment booklet and telephone coaching | Experimental | Not described Receives: Behavioral: Self-help treatment booklet and telephone support |
| Usual Care | Other | Not described Receives: Behavioral: Usual care by a family physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep and bedtime problems trial (Trial 1): parent report on the Children's Sleep Habits Questionnaire
Measured: 7 weeks post randomization
Discipline problems trial (Trial 2): parent rated total problem score on the Eyberg Child Behavior Inventory
Measured: 7 weeks post randomization
Sleep and discipline problems trial (Trial 3): parent report on the Children's Sleep Habit Questionnaire (Group 1-sleep treatment) and parent rated total problem score on the Eyberg Child Behavior Inventory (Group 2-discipline treatment)
Measured: 7 weeks post randomization
Secondary outcomes (4)
Parenting practices-total score on the Parenting Scale
Measured: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
General child behavior problems-total problem score on the Child Behavior Checklist
Measured: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Daily recall ratings of sleep and discipline problems (3 reports in total)
Measured: 4 & 6 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Parent report on the Richman sleep questionnaires (only for Trial 1-sleep and bedtime problems and for Trial 3 participants if in sleep treatment condition)
Measured: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ProblemsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario
- Investigators
- Graham J Reid, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133055
- Sponsor's protocol ID
- 67816; 280205-014
- Other IDs
- ISRCTN81511074
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2005
- Last updated
- 13 Apr 2018
- Results posted
- No
Publications
Reid GJ, Stewart M, Vingilis E, Dozois DJ, Wetmore S, Jordan J, Dickie G, Osmun WE, Wade TJ, Brown JB, Zaric GS. Randomized trial of distance-based treatment for young children with discipline problems seen in primary health care. Fam Pract. 2013 Feb;30(1):14-24. doi: 10.1093/fampra/cms051. Epub 2012 Sep 3.
PubMed 22948337
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting Matters: Helping Parents With Young Children
- ClinicalTrials.gov ID
- NCT00133055
- Acronym / sponsor ID
- 67816; 280205-014
- Conditions
- Sleep Problems, Behavior Problems, Child Behavior
- Keywords
- parenting, sleep problems, behavior problems, brief intervention, self-help, preschool-age children, psychosocial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario
- Study start
- Jul 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Aug 2005 (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.
Sleep and discipline problems are the most common problems for parents of young children (ages 2 to 5 years old) and are the two concerns with the strongest relations to future child behavior problems. The Parenting Matters program combines treatment booklets and telephone support to help parents deal with sleep or discipline problems. Parents with concerns and who are interested in the study are identified during a visit to their family physician. We, the investigators at the University of Western Ontario, expect that parents receiving treatment booklets, along with usual care by their family physician, will have greater reductions in their child's sleep or discipline problems, improved parenting practices, and greater reductions in child behaviour problems after receiving the Parenting Matters intervention, compared to parents receiving usual medical care.
Detailed description
About 1 in 5 young children (ages 2 to 5 years) has a significant psychosocial problem, but over 80% do not receive treatment. Without treatment, up to half of these children will have problems into childhood and adolescence. New methods of treating and preventing children's psychosocial problems are needed.
Sleep and discipline problems (or child non-compliance) are the most common problems for parents of young children, and are the two concerns with the strongest relations to future child behavior problems. Further, parenting practices have consistently been linked to the development of psychosocial problems. The Parenting Matters program combines treatment booklets and telephone support to help parents with sleep or discipline problems among young children.
Objectives:
- Test the efficacy of the Parenting Matters program interventions for sleeping and bedtime behaviors (Trial 1), and discipline (Trial 2) in reducing problem-specific outcomes.
- Test the effects of the Parenting Matters program interventions for parents who are concerned about both their children's sleep and discipline (Trial 3) in reducing problem-specific outcomes related to sleep (Group 1) and discipline problems (Group 2) will be tested.
- Test the efficacy of the Parenting Matters program in improving parenting practices.
- Test the efficacy of the Parenting Matters program in reducing child behaviour problems in general.
- Examine predictors of treatment success.
Method:
All parents of 2 to 5 year-olds seen in a family practice for a routine appointment are asked to complete a psychosocial concerns checklist. Parents who have concerns regarding their child's sleep (Trial 1), how to discipline their child (Trial 2), or concerns about both their child's sleep and discipline (Trial 3), and meet the other study criteria, are invited to take part in the study. Mailed baseline assessment packages assess children's behavior, parenting practices and potential predictors of treatment success.
Parents are randomized to usual care, or the Parenting Matters program along with usual care. The Parenting Matters program includes treatment booklets addressing either sleep or discipline problems, and telephone coach support (3 calls over 6 weeks).
Primary outcomes are parents' ratings of their children's sleep or discipline problems measured at post-treatment (7 weeks after baseline). Parents repeat assessment packages at 3- and 6-month follow-ups.
Goals \& Relevance:
This research addresses the need for new ways of providing early interventions for young children that:
- reach the largest number of individuals in need;
- are cost effective; and
- time efficient.
By addressing the most common issues facing parents of young children, it engages parents in areas of direct relevance to them. The program focuses on parenting practices thereby building family strengths that may have a lasting impact on child development. Collaboration with family physicians builds on the ongoing positive relationships between parents and family physicians and provides a mechanism to reach a significant proportion of young children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment booklet and telephone coaching | Experimental | Behavioral: Self-help treatment booklet and telephone support |
| Usual Care | Other | Behavioral: Usual care by a family physician |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parent (primary caregiver) of a 2-5 year old child
- Attending a medical appointment at a family medical practice
- Phone in home
- Parent concerned about child's sleep and/or discipline
- Parent interested in participating in a treatment study
Key exclusion criteria (4 listed)
- Parent non-English speaking
- Child with significant physical or developmental disability
- Parent's only sleep concern is in regards to a physiological sleep disorder (e.g. sleep apnea, snoring) or bedwetting
- No phone
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 |
|---|---|---|
| Self-help treatment booklet and telephone supportThe Parenting Matters treatment program consisted of a self-help treatment booklet and two telephone coaching calls from a paraprofessional telephone coach at Weeks 2 and 5 of the program. Two booklets were used in the three trials; one addressed sleep issues and the second discipline problems. | Behavioural | Treatment booklet and telephone coaching |
| Usual care by a family physicianParents in the usual care condition were told to continue with care from their family physician and/or any other treatment recommended by the physician. | Behavioural | Usual Care |
Primary outcome
Sleep and bedtime problems trial (Trial 1): parent report on the Children's Sleep Habits Questionnaire
Time frame: 7 weeks post randomization
Discipline problems trial (Trial 2): parent rated total problem score on the Eyberg Child Behavior Inventory
Time frame: 7 weeks post randomization
Sleep and discipline problems trial (Trial 3): parent report on the Children's Sleep Habit Questionnaire (Group 1-sleep treatment) and parent rated total problem score on the Eyberg Child Behavior Inventory (Group 2-discipline treatment)
Time frame: 7 weeks post randomization
4 secondary outcomes
Parenting practices-total score on the Parenting Scale
Time frame: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
General child behavior problems-total problem score on the Child Behavior Checklist
Time frame: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Daily recall ratings of sleep and discipline problems (3 reports in total)
Time frame: 4 & 6 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Parent report on the Richman sleep questionnaires (only for Trial 1-sleep and bedtime problems and for Trial 3 participants if in sleep treatment condition)
Time frame: 7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Derived from this study: PubMed 22948337Reid GJ, Stewart M, Vingilis E, Dozois DJ, Wetmore S, Jordan J, Dickie G, Osmun WE, Wade TJ, Brown JB, Zaric GS. Randomized trial of distance-based treatment for young children with discipline problems seen in primary health care. Fam Pract. 2013 Feb;30(1):14-24. doi: 10.1093/fampra/cms051. Epub 2012 Sep 3.
- Related InfoLink provided by the sponsor.
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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.
Graham J Reid, PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Self-help treatment booklet and telephone support in people with Sleep Problems and Behavior Problems, run by University of Western Ontario, Canada at 1 site in Canada.
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 5 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: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sleep and bedtime problems trial (Trial 1): parent report on the Children's Sleep Habits Questionnaire (time frame: 7 weeks post randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00133055, which also lists 1 linked publication.
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 13 Apr 2018.