Attention Deficit Disorder With HyperactivitySPARCLARNCT03832270
Support for PARents of Children Living With ADHD - a Research Trial
A study testing Parents InC and Incredible Years in people with Attention Deficit Disorder With Hyperactivity, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder characterised by problems in attention, impulse control and activity regulation that substantially burdens patients, families, and society. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Parents InC and Incredible Years
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2019to Oct 2021
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents of children aged 5-12 with a formal diagnosis of ADHD, following a standardised assessment from a paediatrician or a psychiatrist, referred to the Fife integrated ADHD pathway during the one year recruitment period will be eligible for inclusion.
Who cannot join
- Families attending other parenting groups
- Parents who have low proficiency in English (as this will compromise their ability to complete research measures or participate in a group intervention).
- Participants already taking part in research on a parenting intervention will also be ineligible to participate.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Fife Psychology Department
Dunfermline, Scotland, KY11 4UW
Hilary Maddox, Dr, 01383565400, hilarymaddox@nhs.net
Caroline Hollinsworth, 01383 565400, carolinehollinsworth@nhs.net
About this study
Official title: SPARCLAR: A Feasibility Randomised Controlled Trial of a Parenting Support Programme Focussed on Families Affected by ADHD
Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder characterised by problems in attention, impulse control and activity regulation that substantially burdens patients, families, and society. The efficacy of behavioural training for parents of children with ADHD symptoms is well established, however it is less clear which type of parenting intervention should be offered, and which aspects of parenting behaviour to focus on. It is not established whether an intervention designed specifically for families of children with a diagnosis will be more effective and cost effective than less specifically-targeted interventions. The purpose of this study is to determine the feasibility and likely size of a substantive randomised controlled trial comparing an AHDH specific parenting intervention to a diagnostically less-specific parenting intervention.
Read the detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder characterised by problems in attention, impulse control and activity regulation that substantially burdens patients, families, and society. ADHD is often associated with challenging behaviours that can induce negativity, even in parents who would otherwise cope well.The efficacy of behavioural training for parents of children with ADHD symptoms is well established, however it is less clear which type of parenting intervention should be offered, and which aspects of parenting behaviour to focus on. It is not established whether an intervention designed specifically for families of children with a diagnosis will be more effective and cost effective than less specifically-targeted interventions.
Parents In Control (Parents InC) offers specific support around empowerment, information and behaviour management specific to ADHD, as well as understanding of the child's development context. Parents InC has been used for a number of years in Scotland and has been evaluated, with promising results, but with relatively small sample sizes, no long-term follow-up, no economic evaluation and, most crucially, no comparison to an alternative intervention or to a control group. The investigators now need to understand if it: i) is at least as effective as the current best-evidenced alternative, Incredible Years, in impacting children's behaviour outcomes; ii) is cost-effective; and iii) offers something helpful and unique compared to other parenting programmes in terms of parenting self-competence and quality of life.
The purpose of this study is to determine the feasibility and likely size of a substantive randomised controlled trial comparing an ADHD specific parenting intervention to a diagnostically less-specific parenting intervention (Incredible Years). Specific objectives are to test (1) whether parents of children recently diagnosed with ADHD are willing to be randomised to Parents InC or IY; (2) whether sufficient numbers of families can be (a) recruited and (b) retained such that a full-scale RCT is likely to be feasible; (3) whether research procedures and efficacy measures are feasible and acceptable to participating families (including health economic measures and consent to link to routine datasets); (4) whether families participating in Parents InC achieve similar scores on the parenting sense of competence scale at 12 months post randomisation as those in the comparison arm (Incredible Years); (5) Whether the two intervention arms significantly differ on any other measures; and (6) the mean cost per participant of Parents InC.
- Being tested
- Parents InC, Incredible Years
- Keywords
- Parenting support
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents InCBehavioural
Based on social learning theory, Parents InC has been designed specifically for parents of children with an ADHD diagnosis with a particular focus on parenting sense of self competence.
Incredible YearsBehavioural
Also based on social learning theory but focus is not specifically on ADHD.
| Study group | Role | What they receive |
|---|---|---|
| Parents InC | Experimental | Group parenting support intervention based around four pillars: 1) empowerment/ownership; 2) education on ADHD and its effect on family identity/ values; 3) positive parenting in the context of ADHD; 4) making sense of ADHD in a developmental context. It is delivered over 5 weekly 2-hour sessions, a 6 week break, and a follow-up session. Receives: Behavioral: Parents InC |
| Incredible Years | Active comparator | A group parenting support intervention aimed at strengthening parent-child interactions and attachment, reducing harsh discipline and fostering parents' ability to promote children's social, emotional, and academic development. The IY programme is delivered over 14 weekly 2-hour sessions. IY facilitators are videotaped during sessions to maintain intervention fidelity. IY also includes 1-4 pre-intervention preparation sessions which may involve home visits and telephone support and reminders. Receives: Behavioral: Incredible Years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of parents willing to be randomised to Parents InC or Incredible Years.
Measured by number of parents agreed to randomisation throughout the study period.
Measured: Continuous over 1 year study period
Number of parents recruited and retained.
Measured by number of parents recruited and retained throughout the study period.
Measured: Continuous over 1 year study period
Research procedures feasibility and acceptability
Face to face interviews will be conducted with participating families to assess the feasibility and acceptability of research procedures.
Measured: Continuous over 1 year study period
Secondary outcomes (10)
Primary efficacy outcome: Parental Sense of Competence Scale.
17-items measure of parenting self-esteem questionnaire with 2 sub scales. Each item is rated on a 6 point Likert scale anchored by 1= "Strongly Disagree" and 6= "Strongly Agree". A higher score indicates a higher parenting sense of competency. There are no average scores or 'cut-off's' for this tool.
Measured: Baseline, 12-months post-randomisation
Eyberg Child Behaviour Inventory.
36-items measure (parent reported) that assesses the current frequency and severity of child's behaviour. Items are rated on a 7-point intensity scale and a yes/no Problem scale.
Measured: Baseline, 12-month post-randomisation
General Health Questionnaire.
12-items self-report measure of common psychiatric conditions of parents. Each item is accompanied with four responses; "Not at all", "No more than usual", "Rather more than usual" and "Much more than usual". Items are rated on a 4-point response scale.
Measured: Baseline, 12-month post-randomisation
ADHD Symptom Rating Scale-Version 1.
Self-report symptom checklist consisting of 18 DSM-IV criteria for parents. The checklist assesses occurrence frequency of each symptom.
Measured: Baseline, 12-month post-randomisation
Parenting Daily Hassles Scale.
18-items self-report measure of the frequency and intensity of 20 potential parenting 'hassles' to indicate parents stress. The items are rated on a frequency and intensity scale. The frequency scale is scored rarely =1, sometimes= 2, a lot= 3, and constantly = 4. The intensity scale is scored by adding the parents rating of 1-5 for each item. If a 0 has been scored for frequency on an item then it should be scored 0 for intensity. The range for this scale is 0 -100. This measure will be re-collected if there is > 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.
Measured: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
Goal Based Outcomes.
Taken from the Child Outcomes Research Consortium to identify goals and assess progression. Progress toward individual goal is rated on a scale from 0 (no progress) to 10 (goal has been reached). This measure will be re-collected if there is > 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.
Measured: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
EQ-5D-5L
Self-report measure of parent quality of life. The EQ-5D-5L is a descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, some problems, moderate problems, extreme problems. Parents will be also be asked to rate their health on a visual analogue scale. This measure will be re-collected if there is > 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.
Measured: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
Paediatric Quality of Life Inventory (PedsQL)
23-items questionnaire which covers 4 core dimensions (physical, social, emotional and school functioning). Each dimension has 4 levels: never = 0, almost never= 1, sometimes= 2, often= 3 and almost always= 4.
Measured: Baseline, 12-month post-randomisation
Strengths and Difficulties Questionnaire (SDQ)
25-items questionnaire which assesses child's emotional and behavioural problems. Each item is scored 0, 1 or 2. Somewhat true is always scored 1, but whether Not true and Certainly true are scored 0 or 2 depends on whether the item is framed as a strength or difficulty. This measure will be re-collected if there is > 3 months wait period between baseline data collection and the start date of the parenting groups. This will allow the investigators to detect any baseline measure changes over the wait period.
Measured: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
Participant service use
Measured using diaries
Measured: 12-month post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start21 Jan 2019
- Primary completionDec 2019 (estimated)
- Study completionOct 2021 (estimated)
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 Attention Deficit Disorder With HyperactivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel pilot RCT (MRC feasibility phase)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Fife, Chief Scientist Office of the Scottish Government
- Responsible party
- Principal investigator, Lucy Thompson, University of Glasgow
- Investigators
- Lucy Thompson, Principal investigator, University of GlasgowHelen Minnis, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832270
- Sponsor's protocol ID
- HIPS/17/58
- Acronym
- SPARCLAR
- Status last verified
- Mar 2019
- First submitted
- 4 Dec 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The PIs will manage access rights to the data set. We anticipate that anonymised trial data may be shared with other researchers to enable international prospective meta-analyses.
Publications
Sim F, Dalgarno L, McIntosh E, Haig C, Duklas P, McConnachie A, Gillberg C, Minnis H, Thompson L. Families with neurodevelopmental diagnoses are not 'Hard to Reach': Findings from a feasibility trial comparing parenting programmes for parents of children with ADHD. PLoS One. 2025 Sep 17;20(9):e0323959. doi: 10.1371/journal.pone.0323959. eCollection 2025.
PubMed 40961127
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARCLAR: A Feasibility Randomised Controlled Trial of a Parenting Support Programme Focussed on Families Affected by ADHD
- ClinicalTrials.gov ID
- NCT03832270
- Acronym / sponsor ID
- SPARCLAR / HIPS/17/58
- Keywords
- Parenting support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Fife, Chief Scientist Office of the Scottish Government
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 6 Feb 2019 (actual)
- 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.
Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder characterised by problems in attention, impulse control and activity regulation that substantially burdens patients, families, and society. The efficacy of behavioural training for parents of children with ADHD symptoms is well established, however it is less clear which type of parenting intervention should be offered, and which aspects of parenting behaviour to focus on. It is not established whether an intervention designed specifically for families of children with a diagnosis will be more effective and cost effective than less specifically-targeted interventions. The purpose of this study is to determine the feasibility and likely size of a substantive randomised controlled trial comparing an AHDH specific parenting intervention to a diagnostically less-specific parenting intervention.
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic and pervasive disorder characterised by problems in attention, impulse control and activity regulation that substantially burdens patients, families, and society. ADHD is often associated with challenging behaviours that can induce negativity, even in parents who would otherwise cope well.The efficacy of behavioural training for parents of children with ADHD symptoms is well established, however it is less clear which type of parenting intervention should be offered, and which aspects of parenting behaviour to focus on. It is not established whether an intervention designed specifically for families of children with a diagnosis will be more effective and cost effective than less specifically-targeted interventions.
Parents In Control (Parents InC) offers specific support around empowerment, information and behaviour management specific to ADHD, as well as understanding of the child's development context. Parents InC has been used for a number of years in Scotland and has been evaluated, with promising results, but with relatively small sample sizes, no long-term follow-up, no economic evaluation and, most crucially, no comparison to an alternative intervention or to a control group. The investigators now need to understand if it: i) is at least as effective as the current best-evidenced alternative, Incredible Years, in impacting children's behaviour outcomes; ii) is cost-effective; and iii) offers something helpful and unique compared to other parenting programmes in terms of parenting self-competence and quality of life.
The purpose of this study is to determine the feasibility and likely size of a substantive randomised controlled trial comparing an ADHD specific parenting intervention to a diagnostically less-specific parenting intervention (Incredible Years). Specific objectives are to test (1) whether parents of children recently diagnosed with ADHD are willing to be randomised to Parents InC or IY; (2) whether sufficient numbers of families can be (a) recruited and (b) retained such that a full-scale RCT is likely to be feasible; (3) whether research procedures and efficacy measures are feasible and acceptable to participating families (including health economic measures and consent to link to routine datasets); (4) whether families participating in Parents InC achieve similar scores on the parenting sense of competence scale at 12 months post randomisation as those in the comparison arm (Incredible Years); (5) Whether the two intervention arms significantly differ on any other measures; and (6) the mean cost per participant of Parents InC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel pilot RCT (MRC feasibility phase)
| Arm | Type | Receives |
|---|---|---|
| Parents InC | Experimental | Behavioral: Parents InCGroup parenting support intervention based around four pillars: 1) empowerment/ownership; 2) education on ADHD and its effect on family identity/ values; 3) positive parenting in the context of ADHD; 4) making sense of ADHD in a developmental context. It is delivered over 5 weekly 2-hour sessions, a 6 week break, and a follow-up session. |
| Incredible Years | Active comparator | Behavioral: Incredible YearsA group parenting support intervention aimed at strengthening parent-child interactions and attachment, reducing harsh discipline and fostering parents' ability to promote children's social, emotional, and academic development. The IY programme is delivered over 14 weekly 2-hour sessions. IY facilitators are videotaped during sessions to maintain intervention fidelity. IY also includes 1-4 pre-intervention preparation sessions which may involve home visits and telephone support and reminders. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parents of children aged 5-12 with a formal diagnosis of ADHD, following a standardised assessment from a paediatrician or a psychiatrist, referred to the Fife integrated ADHD pathway during the one year recruitment period will be eligible for inclusion.
Key exclusion criteria (3 listed)
- Families attending other parenting groups
- Parents who have low proficiency in English (as this will compromise their ability to complete research measures or participate in a group intervention).
- Participants already taking part in research on a parenting intervention will also be ineligible to participate.
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 |
|---|---|---|
| Parents InCBased on social learning theory, Parents InC has been designed specifically for parents of children with an ADHD diagnosis with a particular focus on parenting sense of self competence. | Behavioural | Parents InC |
| Incredible YearsAlso based on social learning theory but focus is not specifically on ADHD. | Behavioural | Incredible Years |
Primary outcome
Number of parents willing to be randomised to Parents InC or Incredible Years.
Time frame: Continuous over 1 year study period
Measured by number of parents agreed to randomisation throughout the study period.
Number of parents recruited and retained.
Time frame: Continuous over 1 year study period
Measured by number of parents recruited and retained throughout the study period.
Research procedures feasibility and acceptability
Time frame: Continuous over 1 year study period
Face to face interviews will be conducted with participating families to assess the feasibility and acceptability of research procedures.
10 secondary outcomes
Primary efficacy outcome: Parental Sense of Competence Scale.
Time frame: Baseline, 12-months post-randomisation
Eyberg Child Behaviour Inventory.
Time frame: Baseline, 12-month post-randomisation
General Health Questionnaire.
Time frame: Baseline, 12-month post-randomisation
ADHD Symptom Rating Scale-Version 1.
Time frame: Baseline, 12-month post-randomisation
Parenting Daily Hassles Scale.
Time frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
Goal Based Outcomes.
Time frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
EQ-5D-5L
Time frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
Paediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline, 12-month post-randomisation
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline, 3 months post Baseline (if applicable), 12-month post-randomisation
Participant service use
Time frame: 12-month post-randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Derived from this study: PubMed 40961127Sim F, Dalgarno L, McIntosh E, Haig C, Duklas P, McConnachie A, Gillberg C, Minnis H, Thompson L. Families with neurodevelopmental diagnoses are not 'Hard to Reach': Findings from a feasibility trial comparing parenting programmes for parents of children with ADHD. PLoS One. 2025 Sep 17;20(9):e0323959. doi: 10.1371/journal.pone.0323959. eCollection 2025.
- Individual participant dataSharing planned: Undecided. The PIs will manage access rights to the data set. We anticipate that anonymised trial data may be shared with other researchers to enable international prospective meta-analyses.
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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.
Lucy Thompson principal investigator
University of Glasgow
Helen Minnis principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents InC and Incredible Years in people with Attention Deficit Disorder With Hyperactivity, run by University of Glasgow at 1 site in United Kingdom.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiona Sim (01413308254, sparclar@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of parents willing to be randomised to Parents InC or Incredible Years. (time frame: Continuous over 1 year study period). 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 NCT03832270, 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 Mar 2019.