Fetal Alcohol Spectrum DisorderSF-FASDNCT02210455
Parenting Training for Children With FASD
A study testing Strongest Families FASD intervention and Psychoeducation in people with Fetal Alcohol Spectrum Disorder, run by IWK Health Centre at 1 site in Canada.
Trial summary
Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children, and is the leading cause of mental disability in Canada. The term fetal alcohol spectrum disorders (FASD) was established to encompass the full spectrum of teratogenic effects induced by alcohol. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorder
- What is being tested?
- Strongest Families FASD intervention and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jun 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a child between 4-12 years of age with a diagnosis which falls under the umbrella term "Fetal Alcohol Spectrum Disorder" as reported by parents/caregivers.
- The child has been experiencing behavioural problems (as defined by the caregiver) for at least 6 months prior to study screening.
- Have been the primary caregiver for a minimum of 6 months prior to entry into the study.
- Have a reasonable expectation of being be the primary caregiver for at least 6 months after study enrolment.
- Read, write, and understand English.
- Have access to a telephone.
Show all 12Show fewer
- Have access to a computer connected to the Internet.
- Live in Canada.
- CBCL Externalizing t-Score must be ≥64 (clinical range)
- The child meets criteria for behaviour suggestive of FASD
- No suicide attempts within the previous 6 months
- No current risk of suicide attempts
Who cannot join
- Child is NOT able to speak in full sentences or understand everyday language and instructions.
- Parent/caregiver has previously taken part in a Strongest Families Parenting Program.
- Parent/caregiver OR child has been diagnosed with Psychosis.
- Child does not have a diagnosis of schizophrenia, bipolar disorder or major depression.
- Child does not put others as risk of serious harm (i.e., requiring medical attention).
- Parent/caregiver has not completed any of the following parenting programs in the last 6 months: Triple P, COPE, Incredible Years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strongest Families FASD: Parent Training for Challenging Behaviour in Children With Fetal Alcohol Spectrum Disorder (FASD)
Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children, and is the leading cause of mental disability in Canada. The term fetal alcohol spectrum disorders (FASD) was established to encompass the full spectrum of teratogenic effects induced by alcohol. FAS is believed to occur in approximately 1 to 3 per 1000 live births in North America, and it is estimated that FASD may occur as frequently as 1 in 100 live births, making this a public health problem of epidemic proportion. Even though considerable efforts have been aimed at identifying children with FASD, the need for access to services and supports for Canadian families affected by FASD remains unfulfilled. Additionally, there is little empirical data available to influence policy change in how these services and supports are delivered.
A key recommendation contained in the Public Health Agency of Canada's (PHAC) Fetal Alcohol Spectrum Disorder (FASD): A Framework for Action document was the need to determine the types of supports children with FASD and their families require and to develop appropriate mechanisms to provide these services at the community, provincial/territorial and federal levels. This identified need forms the basis of the current proposal.
Read more
Although a variety of psychosocial interventions have been developed to treat neurobehavioural disorders, relatively little research has been conducted that is specifically aimed at improving the behavioral challenges identified in children with FASD. Thus, we hypothesize that (i) a FASD-specific parent/guardian training intervention can be developed using input from major stakeholders to meet the current limitations in access for families seeking services and supports; and (ii) this intervention and its evaluation will provide evidence for feasibility and efficacy to support changes in policy by key decision-makers and provide the basis for developing promising practices in the area of interventions for families affected by FASD. This grant will link academic teams with parents/guardians and decision makers to develop and evaluate a training program for the parents/guardians of children with FASD.
Participants will be recruited from across Canada. The specific objectives of the proposed research program, which will be addressed in three inter-related studies, are to:
- Develop an Internet-based intervention program for parents/guardians of children with FASD between the ages of 4-12 years, that is based on information collected from interviews completed by major stakeholders (e.g., parents/guardians, clinicians, decision-makers, community-based organizations);
- Evaluate the feasibility (usability) of the intervention; and
- Obtain data on outcomes from the randomized controlled trial This research will adopt an integrated knowledge translation and exchange approach where knowledge production, dissemination, uptake and usage will occur seamlessly throughout the project and researchers and knowledge users are engaged in the project right from its inception.
The intervention will be based on the Strongest Families program that is designed to help families learn to deal with common childhood problems in the comfort and privacy of their home, and provide treatment and care via telephone contact with trained coaches, written manuals, videotapes, and audiotapes. This program has been successful in children neurodevelopmental disorders; and will be adapted for use in the FASD population, as children with FASD, share many of the same behavioral characteristics.
- Conditions
- Fetal Alcohol Spectrum Disorder
- Being tested
- Strongest Families FASD intervention, Psychoeducation
- Keywords
- FASD, pFAS, ARND, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder, Static Encephalopathy (Alcohol Exposed), Neurobehavioural Disorder (Alcohol Exposed)
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strongest Families FASD interventionBehavioural
PsychoeducationOther
| Study group | Role | What they receive |
|---|---|---|
| The Strongest Families FASD intervention | Experimental | It is a web-based parent training program with a coach. The program is comprised of 11 sessions, each focusing on a different parenting strategy, delivered using easy to read text, instructional videos and audio clips. One Booster Session is conducted 1 month after completion of Session 11. Receives: Behavioral: Strongest Families FASD intervention; Other: Psychoeducation |
| Psychoeducation | Active comparator | It is a static webpage on IRIS providing FASD information and resources, including recommended book titles, websites and organizations that may be helpful. Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change on the Child Behavior Checklist from baseline to 11 months
It is a standardized questionnaire that assesses adaptive functioning and problems. We will use two versions of the CBCL (CBCL/1 ½ -5 and CBCL/6-18) to accommodate the age range of the sample
Measured: At baseline, and 5 months and 11 months after randomization
Secondary outcomes (2)
A change on the Depression Anxiety & Stress Scale Short Form (DASS-21) from baseline to 11 months
It will be used to evaluate parental distress
Measured: At baseline, and 5 months and 11 months after randomization
Client Satisfaction Questionnaire (CSQ-8)
Measured: Participants will be asked to complete this measure at the end of the intervention, which will probably last on average 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJun 2017
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 Fetal Alcohol Spectrum DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroDevNet, Canadian Institutes of Health Research (CIHR), Queen's University, Public Health Agency of Canada (PHAC)
- Responsible party
- Principal investigator, Patrick J. McGrath, IWK Health Centre
- Investigators
- Patrick McGrath, PhD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210455
- Sponsor's protocol ID
- 1017014
- Acronym
- SF-FASD
- Status last verified
- Aug 2018
- First submitted
- 30 Jul 2014
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only aggregate data will be shared.
Publications
Turner K, Reynolds JN, McGrath P, Lingley-Pottie P, Huguet A, Hewitt A, Green C, Wozney L, Mushquash C, Muhajarine N, Sourander A, Caughey H, Roane J. Guided Internet-Based Parent Training for Challenging Behavior in Children With Fetal Alcohol Spectrum Disorder (Strongest Families FASD): Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2015 Oct 13;4(4):e112. doi: 10.2196/resprot.4723.
PubMed 26462968
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strongest Families FASD: Parent Training for Challenging Behaviour in Children With Fetal Alcohol Spectrum Disorder (FASD)
- ClinicalTrials.gov ID
- NCT02210455
- Acronym / sponsor ID
- SF-FASD / 1017014
- Conditions
- Fetal Alcohol Spectrum Disorder
- Keywords
- FASD, pFAS, ARND, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder, Static Encephalopathy (Alcohol Exposed), Neurobehavioural Disorder (Alcohol Exposed)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- NeuroDevNet, Canadian Institutes of Health Research (CIHR), Queen's University, Public Health Agency of Canada (PHAC)
- Study start
- Jul 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Aug 2014 (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.
Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children, and is the leading cause of mental disability in Canada. The term fetal alcohol spectrum disorders (FASD) was established to encompass the full spectrum of teratogenic effects induced by alcohol. FAS is believed to occur in approximately 1 to 3 per 1000 live births in North America, and it is estimated that FASD may occur as frequently as 1 in 100 live births, making this a public health problem of epidemic proportion. Even though considerable efforts have been aimed at identifying children with FASD, the need for access to services and supports for Canadian families affected by FASD remains unfulfilled. Additionally, there is little empirical data available to influence policy change in how these services and supports are delivered.
A key recommendation contained in the Public Health Agency of Canada's (PHAC) Fetal Alcohol Spectrum Disorder (FASD): A Framework for Action document was the need to determine the types of supports children with FASD and their families require and to develop appropriate mechanisms to provide these services at the community, provincial/territorial and federal levels. This identified need forms the basis of the current proposal.
Although a variety of psychosocial interventions have been developed to treat neurobehavioural disorders, relatively little research has been conducted that is specifically aimed at improving the behavioral challenges identified in children with FASD. Thus, we hypothesize that (i) a FASD-specific parent/guardian training intervention can be developed using input from major stakeholders to meet the current limitations in access for families seeking services and supports; and (ii) this intervention and its evaluation will provide evidence for feasibility and efficacy to support changes in policy by key decision-makers and provide the basis for developing promising practices in the area of interventions for families affected by FASD. This grant will link academic teams with parents/guardians and decision makers to develop and evaluate a training program for the parents/guardians of children with FASD.
Participants will be recruited from across Canada. The specific objectives of the proposed research program, which will be addressed in three inter-related studies, are to:
- Develop an Internet-based intervention program for parents/guardians of children with FASD between the ages of 4-12 years, that is based on information collected from interviews completed by major stakeholders (e.g., parents/guardians, clinicians, decision-makers, community-based organizations);
- Evaluate the feasibility (usability) of the intervention; and
- Obtain data on outcomes from the randomized controlled trial This research will adopt an integrated knowledge translation and exchange approach where knowledge production, dissemination, uptake and usage will occur seamlessly throughout the project and researchers and knowledge users are engaged in the project right from its inception.
The intervention will be based on the Strongest Families program that is designed to help families learn to deal with common childhood problems in the comfort and privacy of their home, and provide treatment and care via telephone contact with trained coaches, written manuals, videotapes, and audiotapes. This program has been successful in children neurodevelopmental disorders; and will be adapted for use in the FASD population, as children with FASD, share many of the same behavioral characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Strongest Families FASD intervention | Experimental | Behavioral: Strongest Families FASD intervention, Other: PsychoeducationIt is a web-based parent training program with a coach. The program is comprised of 11 sessions, each focusing on a different parenting strategy, delivered using easy to read text, instructional videos and audio clips. One Booster Session is conducted 1 month after completion of Session 11. |
| Psychoeducation | Active comparator | Other: PsychoeducationIt is a static webpage on IRIS providing FASD information and resources, including recommended book titles, websites and organizations that may be helpful. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Have a child between 4-12 years of age with a diagnosis which falls under the umbrella term "Fetal Alcohol Spectrum Disorder" as reported by parents/caregivers.
- The child has been experiencing behavioural problems (as defined by the caregiver) for at least 6 months prior to study screening.
- Have been the primary caregiver for a minimum of 6 months prior to entry into the study.
- Have a reasonable expectation of being be the primary caregiver for at least 6 months after study enrolment.
- Read, write, and understand English.
Key exclusion criteria (6 listed)
- Child is NOT able to speak in full sentences or understand everyday language and instructions.
- Parent/caregiver has previously taken part in a Strongest Families Parenting Program.
- Parent/caregiver OR child has been diagnosed with Psychosis.
- Child does not have a diagnosis of schizophrenia, bipolar disorder or major depression.
- Child does not put others as risk of serious harm (i.e., requiring medical attention).
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 |
|---|---|---|
| Strongest Families FASD intervention | Behavioural | The Strongest Families FASD intervention |
| Psychoeducation | Other | Psychoeducation, The Strongest Families FASD intervention |
Primary outcome
A change on the Child Behavior Checklist from baseline to 11 months
Time frame: At baseline, and 5 months and 11 months after randomization
It is a standardized questionnaire that assesses adaptive functioning and problems. We will use two versions of the CBCL (CBCL/1 ½ -5 and CBCL/6-18) to accommodate the age range of the sample
2 secondary outcomes
A change on the Depression Anxiety & Stress Scale Short Form (DASS-21) from baseline to 11 months
Time frame: At baseline, and 5 months and 11 months after randomization
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Participants will be asked to complete this measure at the end of the intervention, which will probably last on average 5 months
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 16 Aug 2018.
- Derived from this study: PubMed 26462968Turner K, Reynolds JN, McGrath P, Lingley-Pottie P, Huguet A, Hewitt A, Green C, Wozney L, Mushquash C, Muhajarine N, Sourander A, Caughey H, Roane J. Guided Internet-Based Parent Training for Challenging Behavior in Children With Fetal Alcohol Spectrum Disorder (Strongest Families FASD): Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2015 Oct 13;4(4):e112. doi: 10.2196/resprot.4723.
- Individual participant dataSharing planned: No. Only aggregate data will be shared.
Related trials for Fetal Alcohol Spectrum Disorder
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Not yet recruitingPhase 2
FASD Prevention R33
Alcohol and Tobacco/Cannabis Use
Recruiting
Families Moving Forward (FMF) Connect Pro for Mental Health Providers
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Recruiting
The Synchrony Study: Examining Music Training for Children With FASD
Fetal Alcohol Spectrum Disorders
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.
Patrick McGrath, PhD principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strongest Families FASD intervention and Psychoeducation in people with Fetal Alcohol Spectrum Disorder, run by IWK Health Centre 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 12 inclusion and 6 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 16 Aug 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.
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?
A change on the Child Behavior Checklist from baseline to 11 months (time frame: At baseline, and 5 months and 11 months after randomization). 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 NCT02210455, 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 16 Aug 2018.