Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical and Cost Effectiveness of a Parent Mediated Intervention to Reduce Challenging Behaviour in Pre-schoolers With Moderate to Severe Learning Disability: a Randomised Controlled Trial
Brief Summary: Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities.The trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual (TAU) whilst the TAU group receive available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data is also being collected to carry out a cost effectiveness and utility evaluation. Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities.


Options:
A: * INCLUSION AND EXCLUSION CRITERIA:

Inclusion and exclusion criteria for each group are outlined below. The total accrual ceiling is 2050, including subjects of both sexes, made up of the following 11 populations:

Pediatric patients with bipolar disorder or SMIBRD:

INCLUSION CRITERIA:

* Age 6-17
* Meet DSM criteria for BD
* Have a primary caregiver who can accompany him or her on trips to NIMH and provide reliable history and information.
* Have a psychiatrist who provides clinical care for their BSD.
* Be able to complete self-rating forms and to cooperate with other study procedures.

EXCLUSION CRITERIA:

* I.Q. \< 70
* Autistic disorder or more than mild autism spectrum disorder;
* Psychosis that interferes with the child s capacity to understand and comply with study procedures
* Unstable medical illness (e.g. severe asthma)
* Medical illness that could cause the symptoms of BSD (e.g. multiple sclerosis, thyroid disease)
* Pregnancy
* Substance abuse within two months of the initial evaluation, since alcohol and abused substances interfere with interpretation of fMRI and cognitive task data.
* NIMH IRP Employee family member

Adults with BD participating as individuals or as parents of at- risk children:

INCLUSION CRITERIA:

* DSM Bipolar Disorder
* Age 18-58
* Be able to complete self-rating forms and to cooperate with other study procedures.
* Medically safe to perform MRI

EXCLUSION CRITERIA:

* Diagnosis of schizophrenia or other current psychosis.
* Claustrophobia or anxiety that prevents participation in MRI
* Any serious medical illness, such as heart, liver, or kidney disease.
* A history of drug or alcohol abuse in the past 90 days.
* Current or past seizure disorder
* Currently unstable hyperthyroidism or hypothyroidism
* Currently receiving medical treatment that would affect mood, such as steroids
* Pregnant or breast-feeding.
* Active suicidal or homicidal thoughts or plans
* NIMH IRP Employee/family member

Healthy volunteer children and adolescents:

INCLUSION CRITERIA:

* Age- and sex- matched to the bipolar patients.
* Have an identified primary care physician.
* Speaks English

EXCLUSION CRITERIA

* I.Q. \< 70
* Any serious medical condition or condition that interferes with fMRI scanning
* Pregnancy
* Past or current diagnosis of any anxiety disorder (panic disorder, GAD, Separation Anxiety Disorder, Social Phobia), mood disorder (manic or hypomanic episode, major depression), OCD, PTSD, Conduct Disorder, psychosis, current suicidal ideation, Tourette
* Disorder, Autism Spectrum Disorder or ADHD.
* Substance abuse within two months prior to study participation or present substance abuse
* History of sexual abuse.
* Parent or sibling with Bipolar Disorder, recurrent MDD, or any disorder with psychosis.
* NIMH IRP Employee family member

Parents of healthy volunteer children (Amish and Non-Amish) and Healthy Adults (not parents):

INCLUSION CRITERIA:

* For healthy adults (not parents): Healthy adults age 25-58
* For parents of healthy volunteers: Parents of control subjects as outlined in B above
* Age 25-58
* Speaks English

EXCLUSION CRITERIA:

* IQ\< 70
* Any current psychiatric diagnosis
* NIMH IRP Employee/family member

Control subjects with ADHD but not BD:

INCLUSION CRITERIA:

* Age 8-17
* Currently meets DSM-IV criteria for ADHD
* t score \>65 on the Connors Parent scales
* Subjects with other psychiatric disorders including anxiety disorders, dysthymic disorder, past major depression, oppositional defiant disorder, tic disorders, and the learning, communication, and elimination disorders may be accepted

EXCLUSION CRITERIA

* IQ\<70
* Pregnancy
* Ongoing medical illness or neurological disorder other than ADHD
* Any condition that would interfere with the participants ability to perform fMRI or other research tasks
* Current Major Depression
* Any past or present manic or hypomanic episode.
* NIMH IRP Employee family member

First- and Second-degree relatives of patients with BD:

INCLUSION CRITERIA:

* First degree relatives (parent or sibling) or second-degree relative (grandparent, grandchild, uncle, aunt, nephew, niece, half-sibling) of patients with BD
* Age 3-58

EXCLUSION CRITERIA:

* Active psychosis
* Dementia
* IQ \< 70
* Any clinical condition in need of immediate care
* Any chronic medical illness resulting in impaired CNS function
* Any condition that interferes with the participants ability to perform research tasks
* NIMH IRP Employee/family member

Amish Community children with BD:

INCLUSION CRITERIA:

* Age 8-17
* Meet DSM-IV criteria for BD
* Have a primary caregiver who can provide a reliable history
* Be able to complete self-rating forms and to cooperate with other study procedures.

EXCLUSION CRITERIA:

* IQ\<70
* Active psychosis
* Any clinical condition in need of immediate care
* Any chronic medical illness resulting in impaired CNS function
* Any condition that would interfere with the participants ability to perform behavioral research tasks
* Limitations with English that would interfere with understanding consent/assent, interview, or task instructions.
* NIMH IRP Employee family member

Amish Community Adults with BD:

INCLUSION CRITERIA:

* DSM-IV Bipolar Disorder
* Age 18-58
* Be able to complete self-rating forms and to cooperate with other study procedures.

EXCLUSION CRITERIA:

* Diagnosis of schizophrenia or other current psychosis.
* Any serious medical illness, such as heart, liver, or kidney disease.
* A history of drug or alcohol abuse in the past 90 days.
* Current or past seizure disorder
* Currently unstable hyperthyroidism or hypothyroidism
* Currently receiving medical treatment that would affect mood, such as steroids
* Active suicidal or homicidal thoughts or plans
* Limitations with English that would interfere with understanding consent/assent, interview, or task instructions.
* NIMH IRP Employee/family member

Amish Community at-risk subjects:

INCLUSION CRITERIA:

* Age 8-17
* Parent or sibling (first-degree relative) diagnosed with BD

EXCLUSION CRITERIA:

* IQ\<70
* Active psychosis
* Any clinical condition in need of immediate care
* Any chronic medical illness resulting in impaired CNS function
* Any condition that would interfere with the participants ability to perform behavioral research tasks
* Limitations with English that would interfere with understanding consent/assent, interview, or task instructions.
* NIMH IRP Employee family member

Amish Community healthy volunteer children \& adolescents:

INCLUSION CRITERIA:

* Age 8-17
* No serious physical or neurological symptoms or disorder by history

EXCLUSION CRITERIA:

* I.Q. \< 70
* Ongoing medical illness
* Neurological disorder (including seizures)
* Past or present substance abuse
* History of sexual abuse
* Limitations with English that would interfere with understanding consent/assent, interview or task instructions
* Past or present psychopathology in control subject or their first-degree relative
* NIMH IRP Employee family member

Amish Community adults who are parents of healthy volunteer children \& adolescents, healthy spouses of Amish adults with BD, or parents of adolescents with BD:

INCLUSION CRITERIA:

* Age 18-58
* No serious physical or neurological symptoms or disorder by history
* For Parents of child with BD or spouses of patient with BD: Spouse or offspring with BD

EXCLUSION CRITERIA:

* I.Q. \< 70
* Ongoing medical illness
* Neurological disorder (including seizures)
* Past or present substance abuse
* History of sexual abuse
* Limitations with English that would interfere with understanding consent/assent, interview or task instructions
* NIMH IRP Employee/family member
* For Healthy volunteers: Past or present psychopathology in participant or their first-degree relative
* For Parents of healthy volunteer children: Past or present psychopathology as in (4) above.

In addition, children with BD (Section B.1.) who wish to receive treatment, including discontinuation of medication while inpatients on the pediatric behavioral health unit at NIH, may be eligible for treatment if they meet the following additional criteria:

All inclusion criteria for B.1 (above)

Treatment failure as defined by current CGAS score \<60

The child s psychiatrist/treating physician agrees that a change in medication regimen is appropriate

EXCLUSION CRITERIA:

All exclusion criteria for B.1 (above)

Any contraindications for MRI scanning, plus claustrophobia or extreme separation anxiety

EXCLUSIONS for MRI Scanning:

* Pregnancy
* Substance abuse within two months of the initial evaluation, since alcohol and abused substances interfere with interpretation of fMRI and cognitive task data.
* Claustrophobia or anxiety that prevents participation in MRI
* Any serious medical condition or condition that interferes with fMRI scanning
* Metal in body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if you were a welder or metal worker, since there may be

small metal fragments in the eye

- Unable to lie comfortably on back for up to 90 minutes
B: Inclusion Criteria:

* Age: Parents 18 years or over; Child aged 30-59 months at identification;
* Child has moderate to severe intellectual disability (parent reported Adaptive Behaviour Assessment System (ABAS) General Adaptive Functioning 20-69);
* Written informed consent by parent/caregiver;
* Reports of challenging behaviour over a 6-month period but no less than 2 months.

Exclusion Criteria:

* Child has mild, profound or no LD on parent reported ABAS;
* Parent/carer has insufficient English language to complete study questionnaires;
* Another sibling is taking part in the study.
C: Inclusion Criteria:

* Children with intellectual deficiency (5-13 years) (40 \< total IQ \< 75) with or without autism spectrum disorders
* Native French speaker
* Clinically stable
* Parental consent

Exclusion Criteria:

* visual or auditory disorder
* history of neurological illness or trauma
* Absence of language
D: * INCLUSION CRITERIA:

  1. Inclusion criteria for children with DMDD, subthreshold DMDD:

     1.1.1 Ages 7-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25.

     1.1.2 Abnormal mood (specifically, anger, sadness, and/or irritability), present at least half of the day most days (or at least half the day at least one day per week for subthreshold), and of sufficient severity to be noticeable by people in the child s environment (e.g. parents, teachers, peers).

     1.1.3 Compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property. Such events occur, on average, at least three times a week. For subthreshold DMDD such tantrums occur on average at least once per month.

     1.1.4 The symptoms in # 1.1.2, and 1.1.3 above are currently present and have been present for at least 12 months without any symptom-free periods exceeding three months.

     1.1.5 The onset of symptoms must be prior to age 10 years.

     1.1.6 For DMDD the symptoms are severe in at least in one setting (e.g. violent outbursts, assaultiveness at home, school, or with peers) and at least mild (distractibility, intrusiveness) in a second setting. For subthreshold DMDD, there must be evidence of impairment causing distress to the child or to those around him/her in at least one setting.
  2. Parents of children and adolescents with DMDD or subthreshold DMDD enrolled in 02-M-0021

     2.1.1. Are capable of performing behavioral tasks and/or scanning.

     2.1.2. Speaks English
  3. Healthy Volunteer (Control) Children

     3.1.1. Control subjects will be group matched to the patients.

     3.1.2. Have an identified primary care physician.

     3.1.3. Speaks English
  4. Healthy Volunteer Adults

     4.1.1 Control subjects will be group matched to the patients.

     4.1.2. They will have normal physical and neurological examinations by history or checklist

     4.1.3. Have an identified primary care physician.

     4.1.4 Speaks English
  5. Children with Major Depressive Disorder (MDD) Inclusion criteria (all must be met):

     5.1.1 Ages 11-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25.

     5.1.2. DSM-IV or DSM-5 Major Depressive Disorder

     5.1.2.1 Five or more of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure.

     5.1.2.1.1 Depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feeling sad, blue, down in the dumps, or empty) or observation made by others (e.g., appears tearful or about to cry). (In children and adolescents, this may present as an irritable or cranky, rather than sad, mood.)

     5.1.2.1.2 Markedly diminished interest or pleasure in all, or almost all, activities every day, such as no interest in hobbies, sports, or other things the person used to enjoy doing.

     5.1.2.1.3. Significant weight loss when not dieting or weight gain (e.g., a change of more than 5 percent of body weight in a month), or decrease or increase in appetite nearly every day.

     5.1.2.1.4. Insomnia (inability to get to sleep or difficulty staying asleep) or hypersomnia (sleeping too much) nearly every day

     5.1.2.1.5. Psychomotor agitation (e.g., restlessness, inability to sit still, pacing, pulling at clothes or clothes) or retardation (e.g., slowed speech, movements, quiet talking) nearly every day

     5.1.2.1.6. Fatigue, tiredness, or loss of energy nearly every day (e.g., even the smallest tasks, like dressing or washing, seem difficult to do and take longer than usual).

     5.1.2.1.7. Feelings of worthlessness or excessive or inappropriate guilt nearly every day (e.g., ruminating over minor past failings).

     5.1.2.1.8. Diminished ability to think or concentrate, or indecisiveness, nearly every day (e.g. appears easily distracted, complains of memory difficulties).

     5.1.2.1.9. Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideas without a specific plan, or a suicide attempt or a specific plan for committing suicide

     5.1.2.1.10 Symptoms cause clinically significant distress or impairment in social, occupational/academic, or other important areas of functioning.

     5.1.2.1.11. The episode is not attributable to the physiological effects of a substance or to another medical condition.

     5.1.3. Youth with MDD who are continuing in research as adults must also be receiving psychiatric care for their MDD, if it is ongoing
  6. Children with Attention-Deficit/Hyperactivity Disorder (ADHD)

6.1.1. Age 8-17

6.1.2. Currently meets DSM-IV or DSM-5 criteria for ADHD

6.1.3. Subjects with other primary psychiatric disorders including anxiety disorders, dysthymic disorder, past major depression, oppositional defiant disorder, tic disorders, and the learning, communication, and elimination disorders may be accepted

6.1.4. Have an identified primary care physician.

6.1.5. Speaks English

EXCLUSION CRITERIA:

1.3 Exclusion criteria for those with DMDD:

1.3.1 The individual exhibits any of these cardinal bipolar symptoms:

1.3.1.1 Elevated or expansive mood

1.3.1.2 Grandiosity or inflated self-esteem

1.3.1.3 Decreased need for sleep

1.3.1.4 Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences)

1.3.1.5. Has BD symptoms in distinct periods lasting more than 1 day.

1.3.2. Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD.

1.3.3. IQ\< 70

1.3.4. The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition.

1.3.5. Currently pregnant or lactating

1.3.6. Meets criteria for alcohol or substance abuse with the last three months

2. Exclusion of parents of children and adolescents with DMDD or subthreshold DMDD

2.1 Have an I.Q. \< 70

2.2 Have any serious medical condition or condition that interferes with participation

3.2 Healthy Volunteer Exclusion criteria:

3.2.1. I.Q. \< 70;

3.2.2. Any serious medical condition or condition that interferes with fMRI or MEG/EEG scanning

pregnant or lactating;

3.2.3. Past or current diagnosis of any anxiety disorder (panic disorder, GAD, Separation Anxiety Disorder, Social Phobia), mood disorder (manic or hypomanic episode, major depression), OCD, PTSD, Conduct Disorder, psychosis, current suicidal ideation, Tourette Disorder, Autism Spectrum Disorder or ADHD.

3.2.4. Substance abuse within two months prior to study participation or present substance abuse

3.2.5. History of sexual abuse.

3.2.6. Parent or sibling with Bipolar Disorder, recurrent MDD, or any disorder with psychosis.

4.2 Healthy Volunteer Adult Exclusion criteria:

4.2.1. IQ\< 70

4.2.2. Pregnant

4.2.3. Any past or current history of Bipolar Disorder (any manic or hypomanic episode), recurrent MDD, or any disorder with psychosis

5.3 Exclusion criteria for those with MDD:

5.3.1 The individual exhibits any of these cardinal bipolar symptoms:

5.3.1.1 Elevated or expansive mood

5.3.1.2 Grandiosity or inflated self-esteem

5.3.1.3 Decreased need for sleep

5.3.1.4 Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences)

5.3.1.5. Has BD symptoms in distinct periods lasting more than 1 day.

5.3.2. Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD.

5.3.3. IQ\< 70

5.3.4. The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition.

5.3.5. Currently pregnant or lactating

5.3.6. Meets criteria for alcohol or substance abuse with the last three months

6.2. Exclusion criteria for those with ADHD:

6.2.1. IQ\<70

6.2.2. Pregnancy (excludes for scanning only)

6.2.3. Ongoing medical illness or neurological disorder other than ADHD

6.2.4.\<TAB\>Any condition that would interfere with the participants ability to perform

research tasks

6.2.5. Current Major Depression

6.2.6. Any past or present manic or hypomanic episode

Answer: B